• Arranges/schedules required appointments
• Learns and supports all aspects of the study operations (subject management/regulatory) with substantial oversight from the investigator or their designee.
• Primarily supports subject management, such as subject visit preparation, performs data entry in the Clinical Trial Management System (CTMS), scans informed consents into the Electronic Medical Record (EMR), and supports data entry needs of the study.
• Assists with the compiling and maintaining essential records and documents required by Dartmouth-Hitchcock Medical Center (DHMC) and various sponsor organizations in compliance with applicable standards and operating procedures for the execution of clinical trial operations, including timely Institutional Review Board (IRB) submissions meeting sponsor and departmental requirements.
• Provides support to the supervisor and IRB about regulatory and sponsor-related issues.
• Assists with maintaining accurate and timely sponsor communications regarding the status of research studies.
• Under the direction of the supervisor, assists DHMC investigators with regulatory processes.
• Maintains basic current understanding of IRB and Dartmouth-Hitchcock Health (D-HH) Institutional processes.
• Maintains and tracks on-site and off-site storage of required study records and assists with data entry and accurate use of a tracking system for maintaining required essential documents.
• Assists with local and commercial IRB, including initial submissions, modifications, renewal applications, and study closeout procedures.
• Assists with scheduling and coordination of site visits, participates in site visits, and tracks and ensures action items noted during site visits are completed and closed.
• Tracks all required essential regulatory documents according to International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines, including investigators' Curriculum Vitae (CVs), medical licenses, Collaborative Institutional Training Initiative (CITI), clinical laboratory certifications, etc.
• Adheres to the principles for the ethical conduct of research and safeguards for the protection of human subjects, especially when conducting research with vulnerable populations.
• Understands and prioritizes the safety of research participants.
• Utilizes Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations.
• Completes data entry related to test results and/or measures according to protocol, and appropriate to role, and completes paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.
• Assists with investigating incomplete, inaccurate, or missing data and or documents to ensure accuracy and completeness of data, follows Standard Operating Procedures (SOPs) for data quality assurance.
• Appropriately utilizes standard processes, policies, and systems to ensure data integrity, attribution, and security.
• Understands and demonstrates the professional guidelines and code of ethics related to the conduct of clinical research.
• Completes all D-H and project-specific training requirements.
• Assists with administrative tasks associated with clinical research studies (e.g., document and supply management).
• Maintains lab kits and creates and maintains regulatory and subject binders.
• Participate in manuscript/abstract development.
• Communicates appropriately (written and oral) between stakeholders.
• Assists with communications between principal investigators, regulatory agencies, D-H stakeholders, and study participants to resolve problems.

Skills: Appointment Scheduling, Clinical Data Entry, Regulatory Compliance, Document Management, IRB Submission Support, Electronic Medical Record Management, Site Visit Coordination, Stakeholder Communication

• Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subjects' research and incorporates them in the conduct of research:
• With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional and departmental policies and procedures and federal regulations
• Communicates a basic knowledge and understanding of the management and implementation of clinical/translational research operations
• Uses coordination skills and works collaboratively with study participants, other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures
• Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor before, during and after the conduct of a clinical/translational trial
• Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
• Procures equipment and supplies needed to fulfill project requirements
• Participates in the determination of eligible candidates for study participation, assuring that participants fulfill eligibility requirements
• Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness, and timeliness
• Attends to query resolution on time
• Ensures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
• In a timely fashion, monitors, detects and reports adverse events meeting the requirements of regulatory bodies
• Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
• Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory following sponsor and shipping guidelines and regulations, maintaining appropriate documentation
• With direction, assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports
• With supervision, develops and manages study budgets, monitors efficient invoicing and takes appropriate action to maintain clinical trial billing compliance

Skills: IRB Submission Preparation, Clinical Research Operations, Participant Recruitment, Data Collection and Entry, Regulatory Documentation, Site Visit Support, Specimen Handling and Shipping, Study Budget Management

• Collaboratively participates in study team meetings
• Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors
• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
• With guidance, assesses and evaluates potential participants' pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation
• Engages in open and positive communication with study participants and coworkers
• Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial
• Encourages open communication with participants by providing them with contact information and being available to answer, address or refer their calls
• With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and on time reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required
• Utilizes or obtains knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
• Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development
• Pursues avenues to continue education (i.e., in-services, seminars, etc.)
• Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
• Participates in research-related programs, such as the Clinical/Translational Research Staff Council, by reviewing information and attending meetings open to research staff

Skills: Team Collaboration, Stakeholder Communication, Participant Advocacy, Eligibility Assessment, Informed Consent Process, Protocol Compliance, Adverse Event Reporting, Professional Development

• Report to the Study Manager or CVS Health Leaders.
• Train trial delivery staff on protocol-specific requirements, terminology, and procedures.
• Manage and prepare study materials/equipment, documentation, storage, and disposal/return.
• Ensure essential documents (IB, protocol, ICFs, and CRFs) are current and maintained.
• Coordinate internal and external study events/meetings, including SQV, SIV, IMV and trainings, audits and inspections.
• Draft and submit IRB submissions, including initial submission, annual review, study closeout SAE reporting and protocol deviations.

Skills: Staff Training, Study Material Management, Documentation Maintenance, Meeting Coordination, IRB Submission, Protocol Compliance, Audit Support, Event Planning

• Manage all aspects of the assigned clinical study activities, including remote and site monitoring. 
• Conduct the Initiation visits, routine monitoring, the close-out of clinical sites and maintenance of the Investigators' study files
• Monitor the assigned study sites according to protocol regulations, SOPs, GCP and ICH guidelines
• Provide timely and accurate visit reports
• Ensure that all the site staff involved in the study will receive accurate instructions and tools to ensure patients' safety and quality data

Skills: Clinical Study Management, Remote and On-Site Monitoring, Site Initiation, Routine Monitoring, Site Closeout, Regulatory Compliance, Visit Report Preparation, Staff Training and Support

• Site development and training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites following regulatory requirements, GSK operating standards, and good clinical practices
• Assist sites and the study team during audits/inspections
• Ensure study objectives and optimal study conduct by partnering with Study Management and other relevant stakeholders
• Proactively manage the Trial Master File and Country File to the required SOP and regulatory standards
• Identify, escalate, and resolve all monitoring and regulatory issues in partnership with the investigator, site personnel, and study teams

Skills: Site Development, Site Training, Site Initiation, Site Monitoring, Site Closeout, Audit and Inspection Support, Trial Master File Management, Regulatory Issue Resolution

• Prepare clinical study training material and reagent kits for clinical test sites
• Prepare research/study protocols and process documentation that meet IRB requirements
• Work with clinical sites, Clinical Affairs, or CRO’s to review and troubleshoot data and ensure compliance with research protocols
• Maintain project databases and study binders
• Have an understanding of product design, development, and commercialization for molecular diagnostic products
• Be a strong collaborator and operate efficiently in a fast-paced environment

Skills: Training Material Prep, Reagent Kit Prep, Protocol Development, Process Documentation, Data Troubleshooting, Database Management, Product Development, Team Collaboration

• Perform all types of site visits (selection, initiation, interim and close out)
• Work following company SOPs, GCP guidelines and country-specific regulations
• Site management activities to ensure adherence to protocol, SDV and CRF
• Develop, collect, review and edit clinical trial documentation
• Assist in protocol design
• Ensure the adequacy of drug shipment and drug accountability
• Liaise and form positive working relationships with all colleagues, study site staff and sponsor representatives
• Work closely and provide support to the study Project Manager
• Organise and/or attend investigator meetings

Skills: Site Visit Management, SOP Compliance, Site Management, Document Review, Protocol Design Support, Drug Accountability, Stakeholder Liaison, Project Manager Support

• Assist in overseeing TP Therapeutics’ clinical trials from initiation, planning, execution, maintenance and close-out.
• Coordinate investigational site startup activities, including the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions and approvals, reviewing/approving Essential document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
• Coordinate contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
• Review invoices from vendors/consultants as per the contract.
• Coordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, and query resolution.
• Review and approve Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
• Participate in Site Initiation Visits.

Skills: Trial Oversight, Site Startup Coordination, Document Preparation, Ethics Submission, Vendor Coordination, Invoice Review, Data Tracking, Visit Report Review

• Conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.
• Support in the review of CRFs, study guides, study reference binders, patient diaries, and forms, including participating in the EDC and IxRS specification process and UAT.
• Assist in the planning of Investigational Meetings and/or Site and CRA trainings.
• Assist with protocol, case report form, source document template development, internal SOP/guideline development, and final report preparation.
• Review clinical databases on a real-time basis to identify/resolve data entry issues, track the query process to identify/report evolving trends in the data.
• Coordinate the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples).
• Coordinate the exchange of TMF documents with external service providers, and periodic reviews and QC of the Trial Master File to ensure audit and inspection readiness.
• Serve as a liaison and resource for investigational sites.
• Participate in the development, review, and implementation of departmental SOPs and processes.

Skills: Co-Monitoring Visits, CRF Review, Meeting Planning, Protocol Development, Data Query Management, Sample Oversight, TMF Coordination, Site Liaison

• Prior experience in research or a related field/setting.
• Proficiency in a second language via successful completion of a language assessment may be required for certain departments.
• Pediatric research experience.
• Communicate and work well in a team environment
• Able to effectively prioritize work daily
• Self-motivated and able to work independently as well as in a team.
• Ability to prioritize and problem-solving skills, with demonstrated competency in applying clinical knowledge to patient management.
• Able to meet multiple deadlines for concurrent projects.

Qualifications: . BS in Health Sciences with 2 years of Experience

• Must have knowledge of cancer and clinical protocols.
• Related clinical research experience.
• Experience in project management.
• Ability to communicate effectively, both orally and in writing.
• Ability to create and conduct presentations to public and professional audiences.
• Ability to analyze and synthesize data, prepare and present reports
• Ability to maintain patient confidentiality.
• Ability to understand federal regulations and translate those regulations to guide the research work.
• Ability to facilitate and lead a multidisciplinary team of professionals involved in research studies.
• Prior experience with regulatory (work with IRB, work with study sponsor)
• Experience in data management and data abstraction
• Experience in research patients’ management (consenting, checking study eligibility, scheduling visits, reporting adverse events/serious adverse events, response to treatment, etc.)

Qualifications:  BS in Public Health with 3 years of Experience

• Prior clinical research coordination or nursing experience 
• Certified as a Clinical Research Professional, or will obtain CCRP within 6 months of becoming eligible, but no later than 2 years after hire
• Demonstrates knowledge and skills following Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations, and other federally mandated guidelines
• Must be comfortable working with patient populations
• Computer competency in using Microsoft Office, including Word, Excel, and Outlook, prior experience with Electronic Data Capture (EDC) systems or databases
• Ability to follow protocols and directions very closely
• Ability to grasp the rationale for the methods used and careful attention to the details of the protocols
• Proficient knowledge of medical terminology and human subject research
• Ability to read, write, speak, and understand English
• Ability to communicate effectively, both verbally and in writing
• Ability to travel throughout the Johns Hopkins All Children's Hospital's service areas on time.

Qualifications: BS in Biology with 5 years of Experience

• Experience in a healthcare setting or clinical research (CRA, Regulatory, clinic, CRO, pharma/biotech/device company, or other related experience)
• Certification in clinical research (ACRP/SOCRA or equivalent)
• Knowledge of complex clinical research concepts gained through education and experience.
• Works with a high degree of independence, using discretion and independent judgement in the execution of tasks.
• Human relations and interpersonal skills for interacting with patients and team members.
• Attention to detail and accuracy
• Ability and willingness to work irregular hours as necessitated by research protocols.
• Excellent verbal and written communication skills with telephone diplomacy.
• Working knowledge of Information Systems and database management.
• Excellent analytical and time management skills.
• Knowledge and assessment skills to provide age-appropriate care and protocol requirements.

Qualifications: BS in Clinical Research with 4 years of Experience

• Experience in a research environment
• Knowledge of protocol designs, study objectives and study procedures
• Knowledge of the drug development process, ICH guidelines and GCP
• Excellent written and oral communication skills
• The ability to prioritize workloads
• Good organizational skills
• Previous customer service experience
• Previous experience in coordinating people or processes

Qualifications: BS in Pharmacology with 2 years of Experience

• Related research support experience or the equivalent combination of education and experience.
• Experience must indicate the ability to work with minimal supervision in a team environment.
• Demonstrated ability to create and follow research project-related supporting documents.
• Proven ability to schedule and coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to the timeline.
• Demonstrated ability to report on the status of project deliverables and draft and submit project updates to the study sponsor.
• Strong clinical and analytical skills.
• Proven ability to evaluate and assess subjects’ suitability for inclusion into studies, obtain informed consent, determine patient eligibility, and coordinate patient enrollment.
• Oncology clinical trial experience.
• Experience indicating ability to work with minimal supervision in a team atmosphere and receptiveness to direction.

Qualifications: BS in Psychology with 3 years of Experience

• Clinical trial regulatory experience.
• Knowledge of standard qualitative and quantitative data collection techniques.
• Must have human subjects training.
• Familiarity with social science research methodology.
• Prior experience within the DoD/VA systems of care.
• ACRP/CCRP and Specialty Healthcare License
• Ability to follow detailed instructions.
• Excellent communication skills, basic clinical acumen, knowledge of universal precautions, organizational skills, and proficiency in research conduct.

Qualifications: BS in Health Sciences with 2 years of Experience

• Completion of an accredited Medical or Phlebotomy training program.
• Experience in a Clinical Research setting
• MA or Phlebotomy Certificate, and a current BLS (CPR) Certificate
• Basic computer skills, including Microsoft Word, Windows, and an e-mail system.
• Working knowledge of medical terminology.
• High level of customer service skills with a genuine caring approach to helping people.
• Maintain a positive attitude with changing conditions.
• Strong written and verbal communication skills to communicate effectively with individuals at all levels of the organization.
• Must have a professional and mature demeanor.
• Must be able to work in a fast-paced department and handle multiple tasks, work with interruptions, and deal effectively with confidential information.
• Excellent interpersonal skills for effective interactions with patients and staff.

Qualifications: BS in Pharmacology with 4 years of Experience

• Previous clinical research experience
• Knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting.
• Excellent written and oral communication skills.
• Ability to understand complex written and oral instructions.
• Basic computer knowledge and applications for the generation of business correspondence and the preparation of regulatory and other study documents.
• Strong interpersonal skills with excellent attention to detail.
• Exceptional organizational skills with the ability to set and meet deadlines with high-quality work.
• Ability to set and meet deadlines with high-quality work.

Qualifications: BS in Nursing with 2 years of Experience

• Previous professional research coordination and/or patient navigator experience.
• Previous experience recruiting and enrolling participants for the All of Us Research Program.
• CPR/BLS certification, Phlebotomy certification.
• Experience with laboratory equipment.
• Demonstrated knowledge of and regulations related to state and federal guidelines, and Good Clinical Practices.
• Advanced analytical skills to evaluate information, practices, and procedures, formulate logical and objective conclusions, and make recommendations for effective solutions.
• Experience and working knowledge of research databases, electronic data capture systems, medical record systems, Microsoft Word, Excel, and associated software.
• Knowledge of regulatory processes and guidelines, as well as a working knowledge of data management activities.
• Demonstrated organizational skills with experience in multi-tasking with excellent judgment
• Working knowledge of HIPAA.
• Demonstrated experience working directly with customers and/or patients.
• Experience working individually and as a team member in a diverse workforce.
• Demonstrated oral communication and interpersonal skills for effective, positive, and congenial interactions and correspondence with the public, co-workers, patients, clinic staff, PIs, and other health care professionals.

Qualifications: BS in Medical Technology with 7 years of Experience