Job Summary: 

• Assist with daily oversight of projects, including successfully maintaining relationships with other departmental staff to ensure the success of each research project.
• Support Institutional Review Board submissions and modifications.
• Assist with the management of project finances and the ordering of study supplies.
• Manage study research assistants.
• Oversee recruitment and screening of study populations by research assistants.
• Manage and utilize participant tracking to facilitate longitudinal follow-up of participants.
• Assist research assistants in successfully carrying out study procedures.
• Complete a study visit (e.g., screening, informed consent, surveys, qualitative interviews, collection of drug specimens) when research assistants are unavailable.
• Assist the PI in maintaining research/lab social media and websites up-to-date.
• Assist with literature reviews and other tasks to facilitate publications (e.g., formatting of manuscripts).
• Assist the PI in carrying out the aims of research projects via other tasks as they arise.
• Participate in publications and research presentations.

Skills on Resume:

• Project Oversight (Hard Skills)
• IRB Compliance (Hard Skills)
• Team Supervision (Soft Skills)
• Participant Recruitment (Hard Skills)
• Data Tracking (Hard Skills)
• Clinical Procedures (Hard Skills)
• Manuscript Preparation (Hard Skills)
• Stakeholder Collaboration (Soft Skills)

Job Summary: 

• Assist with administrative tasks for the Principal Investigator, including scheduling and taking notes at internal and external meetings and managing multiple calendars.
• Track participant completion of surveys and intervention requirements to monitor progress.
• Conduct racial equity analysis on state and federal evaluation projects.
• Conduct data entry, cleaning, and analysis for use in the development of government reports and peer-reviewed publications.
• Coordinate with grant partners to roll out youth engagement interventions nationwide.
• Participate in national and state-level special interest groups, providing research and information about the child welfare system’s role in addressing cross-sectional social welfare issues.
• Manage communications for the National Research Collaborative for Foster Alumni and Higher Education.
• Produce written materials (research/policy briefs, reports, peer-reviewed research articles, blog and social media posts, newsletters) about child welfare-related research and policy for varied audiences.
• Write comprehensive literature reviews on topics related to child welfare for use in government reports and publications.
• Assist with the submission of IRB forms to conduct research.
• Develop online surveys to evaluate youth engagement.

Skills on Resume:

• Calendar Management (Hard Skills)
• Participant Tracking (Hard Skills)
• Equity Analysis (Hard Skills)
• Data Management (Hard Skills)
• Partner Coordination (Soft Skills)
• Research Communications (Hard Skills)
• Literature Review (Hard Skills)
• Survey Design (Hard Skills)

Job Summary: 

• Coordinate with Project Manager, Scientists and laboratory staff, as well as other departments on study coordination activities, including administrative tasks associated with projects.
• Coordinate with the PI and Project Manager on the management of internal and external research projects and timelines, including budgets.
• Create and maintain a research laboratory web page and business communications.
• Coordinate the implementation of databases for research studies and protocols, including IACUC, IBC and IRB.
• Assist the Project Lab Manager with basic laboratory functions, including maintenance of laboratory equipment and ordering supplies.
• Identify areas of process improvement and contribute to the development of SOPs and databases.
• Maintain schedules/calendars, screens and handles all telephone communications with research and clinical collaborators, evaluates incoming and outgoing correspondence and prepares responses.
• Organize and facilitate meetings, conferences, and other special events, including identifying resources and arranging for required support (i.e., Technical, A/V, etc.) for meetings and events.
• Research and analyze data related to administrative functions, supply/inventory management, clinical/regulatory compliance, etc.
• Prepare a variety of communications, reports, charts, written documents, etc. detailing the findings, which may be highly sensitive and confidential in nature.
• Review findings with the lab PI and Project Manager.
• Support the Project Manager in problem-solving and project planning/coordination to ensure efficient service.
• Assist in the development and execution of stated goals and objectives, and serve as a primary point of contact for all administrative issues affecting research collaborators.
• Coordinate the administrative efforts of the research lab for the PI and the Project Manager.

Skills on Resume:

• Study Coordination (Hard Skills)
• Budget Management (Hard Skills)
• Website Maintenance (Hard Skills)
• Regulatory Oversight (Hard Skills)
• Lab Operations (Hard Skills)
• Process Optimization (Hard Skills)
• Meeting Facilitation (Soft Skills)
• Stakeholder Liaison (Soft Skills)

Job Summary: 

• Responsible for collecting and analyzing data on San Diego’s economy.
• Collect, maintain, and analyze EDC’s public and proprietary databases.
• Assist with data collection, analysis, and writing of in-depth reports on emerging economic and industry trends.
• Analyze and write about emerging trends in the San Diego region for a diverse group of stakeholders.
• Assist in the creation of data visualizations, research publications, industry reports, and stakeholder presentations.
• Help source and procure novel data and information for large-scale economic impact studies.
• Work with the research team and outside partners to meet quarterly goals.
• Track progress on various projects and report weekly to the Research Director and team.
• Maintain and streamline internal data tools and controls.
• Manage inbound requests to the general research inbox.
• Track team program budgets.
• Assist with research and the broader team.

Skills on Resume:

• Economic Data Analysis (Hard Skills)
• Database Management (Hard Skills)
• Trend Reporting (Hard Skills)
• Data Visualization (Hard Skills)
• Research Sourcing (Hard Skills)
• Project Tracking (Hard Skills)
• Budget Tracking (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary: 

• Conduct patient screenings and research testing as outlined in protocols primarily at the Puget Sound HCS and other affiliated institutions (American Lake VA, Fred Hutchinson Cancer Center, Valley Medical Center, UW Medical Center, among others).
• Keep an accurate record of research data.
• Blood drawing, hormonal testing, sample handling and processing.
• Muscle function assessment.
• Maintain regulatory/compliance paperwork.
• Perform other duties as specified in IRB-approved protocols.
• Design studies based on research questions of interest for clients and the Moore enterprise.
• Collect data and assist with respondent pool management.
• Analyze data from physiological, quantitative, and qualitative measures.
• Communicate results to a non-technical audience.

Skills on Resume:

• Patient Screening (Hard Skills)
• Clinical Testing (Hard Skills)
• Specimen Handling (Hard Skills)
• Muscle Assessment (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Study Design (Hard Skills)
• Data Analysis (Hard Skills)
• Results Communication (Soft Skills)

Job Summary: 

• Recruit, schedule, and record progression of patients through the research protocol and direct the time course of evaluations and ratings according to standard operating procedures (SOPs).
• Complete informed consent process with participants.
• Conduct ratings and collect data in accordance with the study protocol in a standard, orderly manner, and check for accuracy and completeness.
• Competent in the creation of source documentation and case report forms (CRFs) for research studies and updates.
• Develop proficiency in the use of rating instruments specified in the protocol.
• Achieve rater certification for protocols.
• Collect laboratory samples as mandated by protocol and ensure receipt of laboratory results.
• Procure supplies and related equipment.
• Comply with established Good Clinical Practices (GCP).
• Attend regular research meetings.
• Competent in RedCap or other database software, and able to create basic databases for projects and complete data entry accordingly.
• Complete required clinical research education and training programs (such as CITI Good Clinical Practice and IATA lab specimen transport training).
• Act as liaison between physicians, clinical staff and the IRB office, grant sponsors and regulatory agencies to ensure priorities are clearly communicated and resources are allocated appropriately across multiple ongoing projects.
• Coordinate outreach to and liaison with staff to make research presentations and recruit new clients for various research projects.
• Extract data from complex medical records with expert accuracy.
• Develop rapport with study participants.
• Apply legal, regulatory and policy parameters to promote ethical practices in research involving human participants and to ensure compliance with those regulations and report to the supervisor any concerns.
• Identify and record serious adverse events and adverse events (SAEs and AEs) and report them to the principal investigator.
• Complete institutional review board (IRB) continuing review reports and submit appropriate forms to the IRB for protocol amendments.
• Assist with marketing and promotion of research studies through various marketing channels, such as digital media, television, radio, or other media.

Skills on Resume:

• Patient Recruitment (Hard Skills)
• Informed Consent (Hard Skills)
• Clinical Data Collection (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Database Management (Hard Skills)
• Clinical Liaison (Soft Skills)
• Adverse Event Reporting (Hard Skills)
• Participant Engagement (Soft Skills)

Job Summary: 

• Coordinate activities pertaining to federally-sponsored clinical research, including oversight of research data, organization of regulatory binders and study folders, and management of study databases.
• Oversee submission of documents required by the Institutional Review Board.
• Manage data from and into the database for results and conduct backups.
• Complete recruitment and phone screens for research participants.
• Assist in taking participants to different study locations within the NYU Langone facilities.
• Work collaboratively with many team members within and across BNP at NYU, as well as in other collaborations at different institutions.
• Keep records of all study documentation and documents related to the IRB.
• Accountable for processing and basic analyses of functional MRI data and psychophysiological data within the lab.
• Conduct basic analyses on the data to be gathered.
• Maintain records related to the clinical trial.
• Track participant flow and enrollment, schedule and consent participants.
• Acquire data from patients.
• Manage shipping and transport of samples and materials to be obtained from study participants.
• Coordinate with the pharmacy and clinical labs regarding patients' pills and blood sample processing.
• Coordinate participants' reimbursements and travel reimbursements.
• Process purchases for the lab, including supplies for the experiments.
• Complete all regulatory files and binders as per departmental rules and guidelines, clinical trial guidelines, and IRB guidelines.
• Assist with the training of additional personnel on the team.
• Act as a research contact for patients enrolled in studies.
• Manage case report forms and coordinate visit schedules.
• Assist in dissemination efforts on findings of research activities, including preparation of posters, presentations, and manuscripts.
• Coordinate all study recruitment activities.
• Coordinate and assist with the design and management of advertisements and campaigns to recruit specific populations for research studies.
• Participate in special projects and perform other duties.

Skills on Resume:

• Study Coordination (Hard Skills)
• IRB Compliance (Hard Skills)
• Data Oversight (Hard Skills)
• Participant Recruitment (Hard Skills)
• Neuroimaging Analysis (Hard Skills)
• Sample Handling (Hard Skills)
• Regulatory Filing (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary: 

• Lead the initial submission, modifications, and continuations of the study's Institutional Review Board (IRB) application and any other appropriate parties in order to obtain approval to conduct human subjects research (e.g., ensure the update and submission of necessary documents and/or forms to the appropriate destination).
• Assist with study measure development (e.g., surveys, interview guides).
• Assist with the collection and management of study data.
• Organize and maintain research records.
• Conduct scientific literature reviews.
• Plan and schedule study meetings.
• Assist with the management of study budgets.
• Play an active role in the dissemination of findings, including the preparation of manuscripts and presentations.

Skills on Resume:

• IRB Submissions (Hard Skills)
• Measure Development (Hard Skills)
• Data Management (Hard Skills)
• Record Maintenance (Hard Skills)
• Literature Review (Hard Skills)
• Meeting Coordination (Soft Skills)
• Budget Management (Hard Skills)
• Research Dissemination (Hard Skills)

Job Summary: 

• Establish strong working relationships with a diverse matrix of educational program faculty and staff.
• Together with the project manager and/or principal investigator, collaborate with the research project team internally and externally to address study aims by planning, coordinating and monitoring research activities.
• Participate in ongoing data review and planning.
• Provide backup to the Project Manager.
• Participate in the development of new, related research projects, including new internal or extramural grant submissions.
• Assist with the preparation of grant applications and other grant-related activities.
• Assist with the preparation of progress reports to funding agencies and presentations to sponsoring and regulatory agencies and reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study.
• Assist with the submission of necessary documents required by the NYU Institutional Board (IRB), secure accurate signatures and forward documents and/or forms to the appropriate destination.
• Assist with consultant payments under the principal investigator's current grants.
• Manage course websites and portals for two training programs, the Population Health PhD and the Comparative Effectiveness and Implementation Research Training Program.
• Add students at the start of each semester, update course materials weekly, manage course invites and recordings, and schedule student/instructor meetings.
• Assist with training program outreach and recruitment.

Skills on Resume:

• Stakeholder Engagement (Soft Skills)
• Research Planning (Hard Skills)
• Grant Administration (Hard Skills)
• Progress Reporting (Hard Skills)
• IRB Submissions (Hard Skills)
• Budget Administration (Hard Skills)
• Course Platform Management (Hard Skills)
• Outreach Coordination (Soft Skills)

Job Summary: 

• Responsible for certain clinical research components, including but not limited to data collection from study subjects at multiple sites, including the UW Biomedical Research Lab, UW Hospitals (Harborview and the Montlake Hospital) and Swedish Medical Center, Cherry Hill Campus.
• Independently establish and organize study files, including but not limited to informed consent documents, case report forms, and enrollment/screening logs.
• Screen potential participants via electronic medical record review and discussions with the clinical care team (e.g., attending physician in the UW emergency department).
• Introduce the study to potential participants and obtain informed consent.
• Understand and comply with established IRB policies and protocols for multiple research projects.
• Collect optical data with a custom-designed optical spectrometer system in a clinical setting, including the operating room, emergency department, and in ICU.
• Collect optical data from healthy adult participants in the Biomedical Optics Laboratory.
• Perform basic calibration of the optical equipment.
• Assist in developing and modifying data collection forms.
• Perform data recording and archiving to established standards.
• Report data relevant to carrying out research projects, including any adverse events that occur.
• Coordinate retrieval of clinical data from the Swedish Research Team.
• Transfer, back-up and store data files.
• Maintain accurate and complete data records for all subjects studied, including being responsible for data entry in REDCap databases for multiple studies.
• Maintain confidentiality of subject records and ensure HIPAA compliance.
• Collaborate with study monitors for monitoring visits (on-site and remote) and applicable follow-up.
• Review optical data for sufficient quality.
• Collaborate with external companies for product development feedback, including usability input.
• Assist with the IRB approval process, the design and implementation of investigator-initiated research protocols.

Skills on Resume:

• Clinical Data Collection (Hard Skills)
• Participant Screening (Hard Skills)
• Informed Consent (Hard Skills)
• IRB Compliance (Hard Skills)
• Optical Data Acquisition (Hard Skills)
• REDCap Data Entry (Hard Skills)
• Data Quality Review (Hard Skills)
• Cross-Site Collaboration (Soft Skills)

Job Summary: 

• Conduct recruitment and screening of potential participants for study eligibility.
• Conduct phone screens, obtaining and reviewing physician referrals, developing advertisements, completing and administering questionnaires and assessments/paperwork, and scheduling study visits.
• Review all elements of the screening process with the Principal Investigator, Co-Investigators, and Clinicians, including potential inclusion/exclusion criteria, completed informed consent, documentation of events, and the subject's willingness to participate in the study.
• Schedule participants for all visits and coordinate study activities with external services, including mobile phlebotomy services, LabCorp, CTSI, CBRD and FedEx.
• Conduct the informed consent process and ensure that the participants fully understand what they throughout the study.
• Follow up regularly with participants to remind them of visits and compliance.
• Track participants' flow/visits, study procedures, and regulatory issues.
• Update tracking logs in an organized, timely and accurate manner.
• Conduct study visits and collect participant information for research projects.
• Complete questionnaires, assessments and study tasks with participants, psychophysics procedures, neuro-cognitive tasks, abstraction of data from the electronic medical record, use of tools such as calendars, schedules, and tracking logs to facilitate data collection, and send letters/emails to participants.
• Make referrals to treatment (with proper training and PI approval).
• Complete and document participant reimbursement.
• Complete data entry in a timely manner, resolve data queries, obtain missing information, and maintain participants' charts, case report forms, enrollment logs, and all participants' records.
• Collect, prepare, track, ship, and/or store biological materials following study protocol and using universal precautions.
• Update and submit necessary documents required by the NYU Institutional Review Board (IRB), NYU Office of Clinical Trials, and other appropriate parties in order to secure and maintain approval to conduct human subjects research.
• Maintain regulatory records.
• Assist in preparing reports and required documentation for the IRB and FDA.
• Establish and maintain positive relationships with study team members.
• Coordinate study activities through open communication with Sr. Research Coordinator, Research Coordinators, Research Assistants, Principal Investigator, clinical staff, and site staff.
• Assist in grant writing, presentation development, and manuscript preparation.
• Participate in special projects and other tasks.

Skills on Resume:

• Participant Recruitment (Hard Skills)
• Eligibility Screening (Hard Skills)
• Informed Consent (Hard Skills)
• Visit Coordination (Hard Skills)
• Data Entry (Hard Skills)
• Specimen Handling (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary: 

• Coordinate two recently awarded and related National Institute of Mental Health projects, one which focuses on user-centered design, development, and testing of a mobile health intervention for young adults with early psychosis, and another similarly aiming to build and test a mobile health intervention for early psychosis caregivers.
• Lead and manage the agenda of co-investigator meetings, managing each project.
• Maintain and track project progress through maintaining assessment schedules and project timelines.
• Interact independently with research participants.
• Interact with community mental health centers partnering in the recruitment of individuals from the target population.
• Ensure the protection of human subjects in day-to-day study activities.
• Troubleshoot research protocols and techniques.
• Research literature and consults with other investigators within and outside of the institution to identify and resolve complex issues or problems.
• Monitor data collection through the use of REDCap data capture, Qualtrics, and other data collection software, and tracking the progress of participants.
• Interview participants (i.e., young adults at risk for psychosis and their caregivers) about their experiences in the mental health system and with digital technologies.
• Administer clinical interviews to participants who experience serious mental illness.
• Work directly with participants to troubleshoot technical issues and provide technical support.
• Design and perform all activities related to the project using sophisticated research and data management techniques.
• Collaborate with the PI, preparing relevant portions of grant applications, ensuring compliance of submission with the sponsor requirements.
• Track and coordinate project progress by maintaining assessment schedules and project timelines.
• Assure deadlines are met, and notify project partners of impending deadlines to ensure compliance.
• Work to ensure that all Federal and funding agency guidelines and requirements are met.
• Communicate with the BRiTE Center Investigators as well as study sites and decentralized project staff.
• Assist in preparation of findings for grant proposals, reports, publications and other research projects.

Skills on Resume:

• Project Management (Hard Skills)
• Participant Engagement (Soft Skills)
• Human Subjects Protection (Hard Skills)
• Protocol Optimization (Hard Skills)
• Literature Research (Hard Skills)
• Data Oversight (Hard Skills)
• Clinical Interviewing (Hard Skills)
• Stakeholder Communication (Soft Skills)

Job Summary: 

• Develop and adhere to study protocols, consents, case report forms, and standard operating procedures (SOPs).
• Lead the team’s ethical review process at UW and partner institutions in Kenya, including preparing and submitting applications, modifications, and status reports.
• Lead weekly operational and leadership calls between collaborators in Kenya and Seattle.
• Facilitate communication through coordination of additional project-related meetings and calls.
• Serve as the point-person for SOP, tasks and other document tracking between Kenya, UW, and other collaborative sites.
• Identify operational obstacles and find solutions for proper study implementation.
• Perform related duties with other related projects.
• Coordinate ongoing study activities and respond to project staff questions and concerns.
• Prepare reports and presentations.
• Conduct literature reviews.
• Coordinate routine study reporting requirements, including Progress Reports.
• Responsible for data management.
• Lead development of data management systems.
• Develop and oversee data quality monitoring systems.
• Perform data analysis, report generation, and manuscript writing.
• Coordinate data collection activities.

Skills on Resume:

• Protocol Design (Hard Skills)
• Ethics Oversight (Hard Skills)
• Multisite Coordination (Soft Skills)
• Operational Troubleshooting (Hard Skills)
• Study Coordination (Hard Skills)
• Data Management (Hard Skills)
• Quality Monitoring (Hard Skills)
• Scientific Writing (Hard Skills)

Job Summary: 

• Prepare proposals for new studies by developing schedules of assessments, defining the study objectives, inclusion and exclusion criteria, sample collection/analysis, etc., based on the information provided by the sponsor.
• Uphold Atlantia’s Data Protection processes, ensuring that Data Protection Agreements are sent to Sponsors and signed, and that the principles of GDPR are followed in all clinical trials.
• Search literature and other resources (assessment library, clinicaltrial.gov, etc.) to help determine the gold standard for study design, whilst continuously adding to the assessment tool library.
• Liaise with the Sales Team to gather client requirements for the study outline, including biomarker and other outcomes.
• Liaise with the Science Team to identify suitable tools (questionnaires, assessments, biomarkers) for the required endpoints.
• Liaise with the Operations Team to ensure that the design is feasible within the proposed timeline and resources allocated.
• Liaise with Recruitment, Science, and Medical Team staff to ensure the population definitions are feasible for recruitment, medically relevant to the condition under study, and that the criteria can be assessed in clinic with the resources available.
• Liaise with the statistician if a power calculation is to be performed.
• Contact labs for quotes for sample analysis.
• Liaise with license holders for the costs of copyright fees for questionnaires.
• Maintain the Master Proposal Template document by updating staff names and titles, Ethics submission/meeting dates and ensuring that the department processes are updated appropriately.
• Ensure all information relevant to the study design is shared with the science team to support them with the protocol development.
• Identify sub-processors and update the Sub-processor List.
• Send SLA template to sub-processor, detailing description of services, timelines, budget and payment terms.
• Follow the submission of the final protocol and all subsequent amendments to Ethics/IRB/HPRA, and conduct a final review to ensure any changes are captured.
• Report updates to the sales team, so a budget amendment/change order can be initiated.
• Assist the Science Team with the preparation, quality control checks, and submission of the documentation for ethics, IRB and regulatory applications, and store according to Atlantia’s SOPs and regulatory requirements.
• Liaise with the sponsor for investigational product production, labelling and shipping.
• Act as an unblinded team member and request Randomization Lists from independent statisticians, or set up IWRS with the vendor and create unblinding envelopes.
• Assist with the development and maintenance of the library of scientific resources relevant to commonly used processes at Atlantia.
• Apply knowledge and experience of clinical research operations.

Skills on Resume:

• Study Design (Hard Skills)
• Data Protection (Hard Skills)
• Design Research (Hard Skills)
• Team Liaison (Soft Skills)
• Vendor Management (Hard Skills)
• Ethics Submissions (Hard Skills)
• Protocol Coordination (Hard Skills)
• Clinical Operations (Hard Skills)

Job Summary: 

• Assist in the implementation of an initiative to support long-term care facilities, shelters.
• Conceptualize, create, and write high-quality, innovative KT products and content.
• Work collaboratively with key stakeholders in research, hospitals, and long-term care facilities and other congregate care settings to support the tailoring and implementation of infection prevention and control, wellness, mental health and wraparound resources in a variety of settings, including the development and implementation of a robust, multi-stakeholder dissemination plan.
• Oversee and undertake the collection and management of study-related data, ensuring quality control.
• Monitor the progress of project activities, develop and maintain records of project activities and prepare periodic reports as required by investigators, administrators, funding agencies, and/or regulatory bodies.
• Maintain data documentation and storage of records, in accordance with hospital policies and relevant privacy regulations.
• Collaborate with team members to analyze study-related data, write and edit presentations, reports, proposals, and publications.

Skills on Resume:

• Program Implementation (Hard Skills)
• Knowledge Translation (Hard Skills)
• Content Development (Hard Skills)
• Stakeholder Engagement (Soft Skills)
• Data Management (Hard Skills)
• Project Monitoring (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Research Collaboration (Soft Skills)

Job Summary: 

• Assist in building the pipeline of leads of potential national and international (association, corporate, governmental) business meetings, exhibitions and events.
• Research of potential clients' websites, meeting calendars and various databases to identify potential meetings and find current client contact details.
• Undertake search engine research to complete client account details such as their past and future meetings, attendance figures, exhibition details, decision-making processes and background information.
• Assist in the analysis of information and determine the potential and urgency of collected data for lead generation.
• Assist with qualifying meeting information to identify its potential for ICC Sydney by desktop research and contacting potential clients by email and phone.

Skills on Resume:

• Lead Generation (Hard Skills)
• Client Research (Hard Skills)
• Database Research (Hard Skills)
• Market Analysis (Hard Skills)
• Data Qualification (Hard Skills)
• Account Profiling (Hard Skills)
• Email Outreach (Soft Skills)
• Phone Communication (Soft Skills)

Job Summary: 

• Submit studies for review and approval and provide status updates throughout the startup process.
• Assist the regulatory team with Institutional Review Board (IRB) preparation and submission.
• Screen, schedule, and consent participants in a variety of clinical research programs and/or studies.
• Explain the difference between clinical activities and research activities, risks and benefits of study participation to participants.
• Assist with developing or developing protocol-specific systems and documents, including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs).
• Maintain subject-level documentation and prepare documents, equipment and/or supplies.
• Prepare for and take part in site initiation, monitoring, closeout visits, and document storage activities.
• Conduct and document visits and testing/interviews according to all regulatory and organizational protocols.
• Collect, prepare, process, ship and maintain inventory of research specimens.
• Collect information to determine feasibility, recruitment and retention strategies.
• Employs strategies to maintain participant recruitment and retention rates and assists participants with individual needs.
• Collect, prepare and/or process Adverse Event (AE) information per protocol and provide input for AE reports.
• Complete and submit AE reports, according to institution and sponsor-specific reporting requirements.
• Provide input for and assist with developing IRB-related documents.
• Maintain or collaborate to maintain appropriate documentation.
• Assist with identifying issues related to operational efficiency and share results with management.
• Maintain compliance with institutional requirements and policies.
• Develop and maintain a familiarity with the ethical conduct of research and safeguards when conducting clinical research.
• Assist with the design of safeguards to ensure ethical conduct and to protect vulnerable populations.
• Participate in sponsor-required training.

Skills on Resume:

• IRB Submissions (Hard Skills)
• Participant Screening (Hard Skills)
• Informed Consent (Hard Skills)
• Protocol Documentation (Hard Skills)
• Clinical Visit Management (Hard Skills)
• Specimen Processing (Hard Skills)
• Adverse Event Reporting (Hard Skills)
• Ethical Compliance (Hard Skills)

Job Summary: 

• Obtain information for or coordinate operational plans for multiple research programs and/or studies.
• Prepare for and participate in team meetings.
• Proactively includes others in decision-making and escalates issues to management.
• Assist with the development of proposals or protocols.
• Identify and communicate related shortcomings.
• Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of the clinical research program and/or study aims.
• Participate in the determination of operational/statistical elements for the conduct of clinical and translational programs and/or studies.
• Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data.
• Recognize and report vulnerabilities related to the security of physical and electronic data.
• Adhere to and participate in the development and assessment of quality assurance.
• Assist with recognizing trends related to data quality and escalation.
• Recognize when data agreements or special regulatory requirements exist.
• Assemble the necessary parties to ensure that all required agreements are in place.
• Utilize electronic data capture systems, technologies and software necessary for clinical research program and/or study operations.
• Score tests, enter data and complete required forms accurately and according to protocol.
• Assist with the development of data collection documents and instruments.
• Identify issues related to data capture, collection, or management and recommend solutions.
• Assist with the management of Investigational Products (IP).
• Utilize the required system for handling, dispensing and documenting IP for sponsored protocols.
• Maintain appropriate related documentation and track IP compliance at both protocol and subject levels.
• Participate in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.

Skills on Resume:

• Operations Planning (Hard Skills)
• Stakeholder Coordination (Soft Skills)
• Protocol Development (Hard Skills)
• Data Quality (Hard Skills)
• Regulatory Awareness (Hard Skills)
• EDC Systems (Hard Skills)
• IP Management (Hard Skills)
• Financial Tracking (Hard Skills)

Job Summary: 

• Coordinate pre-launch activities, including drafting protocols, Manual of Procedures, Standard Operating Procedures, and other forms as requested by funders, study documents (e.g., consent, assent, information forms, study advertisements, social media posts), and completing IRB applications.
• Coordinate launch activities, including preparing data collection protocols, case report forms, and other forms (e.g., paper, REDCap, clinical data forms, surveys).
• Coordinate data collection activities (e.g., scheduling data collection dates, coordinating schedules of staff who are participants, coordinating transportation).
• Manage and analyze data and prepare results for publication.
• Prepare reports for funders, tracking volunteer activities and hours, scheduling meetings and other lab gatherings, managing supplies, managing the lab website and social media sites, and other miscellaneous activities.

Skills on Resume:

• Protocol Drafting (Hard Skills)
• IRB Submissions (Hard Skills)
• Study Launch (Hard Skills)
• Data Collection (Hard Skills)
• Data Analysis (Hard Skills)
• Report Preparation (Hard Skills)
• Web Management (Hard Skills)
• Team Coordination (Soft Skills)

Job Summary: 

• Schedule and/or call subjects for appointments, contact participants with reminders or other requirements.
• Prepare, distribute, and process questionnaires.
• Perform clerical duties in the preparation of regulatory documents.
• Maintain all forms and documents, including consent forms and master subject logs.
• File all appropriate correspondence.
• Assist with the screening, recruiting, and obtaining consent of study participants.
• Review medical records and/or perform telephone or in-person interviews to gather data.
• Administer standard study questionnaires and tests, score test measurements and questionnaires, and code data for computer entry.
• Perform quantitative review of forms, tests, and other measurements for completeness and accuracy.
• Extract data from source documents for research studies.
• Collect data and complete case report forms.
• Prepare, process, and ship specimens/samples accurately under well-defined requirements.
• Order and maintain equipment and supplies.
• Process study compensation payments and thank letters to subjects upon completion of trial activities.
• Assist with post-study activities.

Skills on Resume:

• Participant Scheduling (Hard Skills)
• Survey Administration (Hard Skills)
• Regulatory Documentation (Hard Skills)
• Participant Enrollment (Hard Skills)
• Record Review (Hard Skills)
• Data Entry (Hard Skills)
• Sample Handling (Hard Skills)
• Study Support (Hard Skills)