Job Summary: 

• Acts as a resource person between SUNY Oncology Divisions outside community attendings, cooperative groups, and drug companies for protocol monitoring and information.
• Participates and organizes the initiation of studies with pharmaceutical companies and cooperative groups.
• Chart reviews and data collection.
• Determines patient eligibility for protocol participation by way of review of patient's medical records.
• Ensures that treatments, evaluations and dosing modifications are administered per protocol.
• Patient Evaluation/Assessment-Identification of protocol candidates is a major function.
• Attends Tumor Board conferences, and participates in hospital rounds and staff meetings.
• Reviews surgical and pathology reports of cancer patients for protocol candidates.
• Reviews present protocol patients on therapy to ensure toxicity and response to treatment.
• Follows and maintains records on protocol patients for the duration of the study.
• Educates patients and families, as well as oncology staff on the research process and investigational drugs.
• Perform phlebotomy, EKG and process blood and/or urine specimens.

Skills on Resume: 

• Protocol Management (Hard Skills)
• Patient Assessment (Hard Skills)
• Data Collection and Chart Reviews (Hard Skills)
• Clinical Knowledge (Hard Skills)
• Patient Education (Soft Skills)
• Phlebotomy and Specimen Processing (Hard Skills)
• Interdisciplinary Collaboration (Soft Skills)
• Toxicity Monitoring and Treatment Evaluation (Hard Skills)

Job Summary: 

• Contribute to the identification, recruitment and assessment of patients and population-based controls.
• Monitor and ensure the progress of case and control recruitment, and collection of all data (including
• clinical and Neuroimaging data including the acquisition of PET, MR and MEG data).
• Assess and monitor patients receiving standardized treatment (clinical sessions) working closely with collaborators
• Monitor and ensure data quality and integrity.
• Oversee and contribute to, the development of a study database and data entry.
• Contribute to the administration of the study.
• Organise and oversee weekly case and control tracking meetings and quarterly steering group meetings.
• Ensure an effective collaborative relationship with other research workers on the project, as well as with local clinical services and researchers on other related projects.
• Prepare progress reports and papers for publication, as required.
• Contribute to reports, the analysis of data and the dissemination of findings.

Skills on Resume: 

• Patient Recruitment and Assessment (Hard Skills)
• Data Collection and Monitoring (Hard Skills)
• Clinical and Treatment Monitoring (Hard Skills)
• Data Quality and Integrity (Hard Skills)
• Database Management (Hard Skills)
• Project Administration (Hard Skills)
• Collaboration and Relationship Management (Soft Skills)
• Report Preparation and Dissemination (Hard Skills)

Job Summary: 

• Play a key role in the maintenance and scale-up of cell line(s) for performing critical clinical testing in a GCLP environment.
• Play a key role in performing technical laboratory processes, including training on existing assays and clinical testing-related activities as per the schedule and under management discretion in a GCLP environment.
• Perform routine assays with high sample throughput.
• Record all data in specified formats (including electronic) following Good Documentation Practices.
• Responsible for activities related to assay development including optimization and qualification of assays.
• Assist the Laboratory Lead or above with analysis and interpretation of clinical and/or experimental data.
• Ensure that corporate, quality, regulatory and safety procedures/requirements are being observed and followed at all times.
• Maintain accurate inventories and will be responsible for informing lab support about ordering supplies.
• Responsible for facility housekeeping according to regulations.
• Responsible for drafting SOPs, writing reports, and presenting data in various formats.
• Responsible for performing cell culture and will be involved in performing MN assays as per the Manager’s direction.
• Responsible for performing ELISA and cell-based assays as per the Manager’s direction.

Skills on Resume: 

• Cell Line Maintenance and Scale-Up (Hard Skills)
• Technical Laboratory Processes (Hard Skills)
• High-Throughput Assay Execution (Hard Skills)
• Good Documentation Practices (GDP) (Hard Skills)
• Assay Development and Optimization (Hard Skills)
• Data Analysis and Interpretation (Hard Skills)
• Regulatory and Safety Compliance (Hard Skills)
• Inventory Management and SOP Development (Hard Skills)

Job Summary: 

• Responsible for overall clinical study management, including planning, communication, coordination and practical tasks for the studies.
• Coordinates Ethical Committee and Institutional Review Board notifications.
• Creates, maintains and oversees study files and archiving.
• Manages testing laboratories including selection of laboratories for the studies.
• Manages Clinical Research Organizations and ensures monitoring of studies, data collection and handling.
• Prepares, revises, and maintains procedures for the conduct of studies.
• Responsible to design and execute experiments to bridge new lots of critical reagents under Scientist and Manager’s discretion.
• Responsible for performing qualification of assays under the Scientist and Manager’s direction.
• Be responsible for troubleshooting assay-related problems and perform follow-up experiments for assays.
• Able to peer review data for both Good Documentation Practices and scientific content
• Develop the research interests
• Comply with all company policies, procedures

Skills on Resume: 

• Clinical Study Management (Hard Skills)
• Ethics and Regulatory Coordination (Hard Skills)
• Documentation and Archiving (Hard Skills)
• Laboratory Management (Hard Skills)
• Clinical Research Organization Management (Hard Skills)
• Procedure Development and Maintenance (Hard Skills)
• Assay Qualification and Troubleshooting (Hard Skills)
• Scientific Review and Compliance (Hard Skills)

Job Summary: 

• Be expected to take charge of the management of human samples and contribute to a good relationship with clinical partners.
• Collaborate in a multidisciplinary research team in an exciting, fast-paced discovery-oriented environment, and at the interface of several departments, Evotec sites, and with several hospitals.
• Set up and coordinate prospective clinical studies (RIPH2 and RIPH3), helping in creating the design, schedule, and follow-up.
• Write the associated operating procedures in close collaboration with the clinical units involved, and manage the documentation and internal archiving.
• Be the link between clinical centers and the project leader to develop and update the workflow of the human samples and associated clinical data.
• Take charge manage the logistic aspects for the collection of data to the clinical center until their integration into a database, in compliance with GDPR.
• Help to implement all documentation by the quality standard of the company.
• Monitor and track patients at clinical sites
• Work with sites to address enrollment-related issues
• Provide support for the processing of data queries
• Data collection of clinical research cases
• Help implement and monitor clinical studies and trials

Skills on Resume: 

• Clinical Sample Management (Hard Skills)
• Interdisciplinary Collaboration (Soft Skills)
• Study Design and Coordination (Hard Skills)
• Documentation and Procedure Writing (Hard Skills)
• Workflow Development (Hard Skills)
• Logistics and Data Integration (Hard Skills)
• Quality Standards Implementation (Hard Skills)
• Patient Monitoring and Data Query Management (Hard Skills)

Job Summary: 

• Work on studies/projects from start-up to close-out
• Assist in writing and developing clinical protocols, data and tracking forms, case report forms, informed consent documents, training, and clinical study reports, and other study-related documents
• Ensure that study data (such as case report forms, patient records, etc) are reviewed and submitted from sites promptly
• Verify that the rights and well-being of human subjects are protected
• Create, review monitoring visit reports and prepare study binders and provide them to sites
• Assist with protocol writing, ICF creation, and CRF creation and development
• Recruit, select, and train new and existing investigators for studies
• Verify that the investigator(s), and any study staff/coordinators are trained and follow the approved protocol and Good Clinical Practice, and follow any procedures applicable to the study based on local regulatory requirements
• Ensure the conduct of studies/trials complies with approved protocol/amendments
• Monitor investigator performance and adherence to protocols
• Serve as a liaison between Align Technology and the study site, investigators, study coordinators, and staff members
• Work with cross-functional teams to successfully coordinate clinical studies, trials, and projects
• Work cross-functionally to contribute to the design of clinical studies/trials

Skills on Resume: 

• Clinical Protocol Development (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Data Management (Hard Skills)
• Training and Recruitment (Soft Skills)
• Monitoring and Reporting (Hard Skills)
• Human Subject Protection (Hard Skills)
• Cross-functional Coordination (Soft Skills)
• Liaison and Communication (Soft Skills)

Job Summary: 

• Track data query forms, reports, and documents necessary for completion of a clinical study, both in-house and from participating study sites
• Provide technical assistance to study sites regarding the conduct of clinical research
• Ensure proper site training is provided and up-to-date
• Ensure accurate, up-to-date records of all documents and protocols of all clinical studies/trials
• Oversee the status of study devices and traceability for clinical studies/trials
• Assist in writing annual and final clinical study reports
• Ensure the effective fulfillment of objectives and deadlines assigned to the group.
• Follow all departmental and company procedures as indicated in SOPs, quality, administrative, or other systems
• Comply with all safety policies, GCP, local and/or global regulations, standards and procedures.
• Report all unsafe activities to appropriate parties.
• Work closely with data team and other team members of clinical affairs
• Participate in proactive team efforts to achieve departmental and company goals.

Skills on Resume: 

• Clinical Study Documentation Management (Hard Skills)
• Technical Support and Training (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Data Accuracy and Record Keeping (Hard Skills)
• Report Writing (Hard Skills)
• Project Management (Hard Skills)
• Collaboration and Teamwork (Soft Skills)
• Safety and Quality Assurance (Hard Skills)

Job Summary: 

• Assists in design and coordinates the development of complex Orthopedic research projects utilizing specialized knowledge to ensure high-quality outcomes.
• Assists in the development of grant proposals and ensures effective utilization of project resources.
• Prepares and submits protocols, consent forms, progress reports and adverse event reports to the hospital’s Review Committees to gain and maintain hospital approval to conduct research with human subjects.
• Recruit appropriate study patients by determining eligibility status, obtaining permission of patient’s physician and obtaining informed consent to fulfill study contract obligations and to comply with regulatory requirements.
• Collects and records data, and maintains regular contact with study participants to document patient progress accurately and ensure compliance to study protocol.
• Serves as a key contact for the study sponsor, responds to sponsor requests, attends study-related meetings, and collaborates with other study personnel to facilitate the research process.
• Assists with manuscript writing for journal publication and coordinates the development of clinical research protocols, provides data for statistical evaluation, and prepares data for presentation at local and national meetings.
• Participate in study-specific tasks such as investigator identification, recruitment, collection of regulatory documents, and site activation
• Contribute to the development/review of study-specific Monitoring Plans
• Tracks timing/planning of site visits to ensure compliance
• Contribute to the development of study materials, case report forms (CRFs), and informed consent documents for clinical studies
• Review monitoring reports and perform occasional co-monitoring visits with CRO CRAs to ensure a quality process

Skills on Resume: 

• Orthopedic Research Expertise (Hard Skills)
• Grant Writing and Proposal Development (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Patient Recruitment and Management (Hard Skills)
• Data Collection and Analysis (Hard Skills)
• Communication and Collaboration (Soft Skills)
• Manuscript Preparation and Presentation (Hard Skills)
• Study Monitoring and Quality Assurance (Hard Skills)

Job Summary: 

• Support Study Lead to execute study milestones against study timelines
• Tracking of key deliverables during start-up, study maintenance, and close-out
• Generate, review, and distribute reports from internal tracking at requested intervals (Site Status, Enrollment, Dosing)
• Collaborate with the Study Lead to develop/review certain study-specific plans and/or processes
• Present updates at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
• Collect and review essential documents from investigational sites
• Support CTAs with TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Assist in the preparation and review of site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Act as CROs’ CRA/CTA first line of contact for study-related questions/issues
• Work with the CRO to arrange and prepare for Site Qualification Visits, Site Initiation Visits and Site Investigator Meetings
• Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on ClinicalTrials.gov or the EU equivalent

Skills on Resume: 

• Project Management (Hard Skills)
• Reporting and Documentation (Hard Skills)
• Collaboration (Soft Skills)
• Communication (Soft Skills)
• Attention to Detail (Hard Skills)
• Organizational Skills (Hard Skills)
• Site Management (Hard Skills)
• Regulatory Knowledge (Hard Skills)

Job Summary: 

• Contributes to the maintenance of a patient registry for the assigned population.
• Maintains well-organized and accurate documentation in regard to patient information obtained during interviews or through questionnaires that may include surgical information, health history, test results, education, survey responses as well as all other source documents related to the maintenance of the patient registry database. 
• Alert the manager of significant findings and events.
• Audits patient data registry for completeness of the information and contacts patients for interviews who are unable to complete electronically.
• Maintains research and quality data ensures completeness of patient-reported outcomes data and assists in clinical/outcomes research when applicable.
• Review patient-reported outcomes reports and identify pending questionnaires and missing 90-day quality reporting.
• Aids patients with survey completion, either via telephone or in-person, if applicable, for those patients otherwise unable to complete these on their own.
• Collects and reviews, for completeness, all required forms before forwarding them to respective cooperative groups within the required timeframe.
• Contributes to the effective management of clinical research activities.
• Schedules meetings of principal investigators and data managers when requested within the specified timeframe.
• Assists in preparing clinical study documents including revising informed consents and study protocols for submission and continuing review

Skills on Resume: 

• Data Management (Hard Skills)
• Documentation (Hard Skills)
• Attention to Detail (Soft Skills)
• Communication (Soft Skills)
• Clinical Research (Hard Skills)
• Organizational Skills (Soft Skills)
• Quality Assurance (Hard Skills)
• Compliance (Hard Skills)

Job Summary: 

• Reviews and develops a familiarity with the protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Serve as liaison between the neuroscience office and physicians, hospital departments, pharmaceutical companies, research bases, and institutional review board and affiliates.
• Serve as a professional resource and/or instructor regarding clinical trials, protocol procedures, and protocol compliance for investigators, nurses, pharmacists, pathologists, radiologists, and other health care personnel both inside and outside of Memorial.
• Assists in the communication of study requirements to all individuals involved in the study.
• Provides appropriate training and tools for study team members.
• Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study.
• Obtains appropriate signatures and dates on forms in inappropriate places.
• Assures that amended consent forms are appropriately implemented and signed.
• Work with physicians to find new patients for trials, screen for eligibility, and consent/enroll.
• Abstract and submit patient information at required intervals for both current patients as well as those in the follow-up phase.
• Responsible for data management activities that relate to any neuroscience data coordinated through the Comprehensive Stroke Center.
• Responsible for data extraction and data entry into the national registry for stroke patients.

Skills on Resume: 

• Clinical Protocol Management (Hard Skills)
• Liaison and Communication (Soft Skills)
• Clinical Training and Instruction (Hard Skills)
• Informed Consent Process (Hard Skills)
• Patient Recruitment and Enrollment (Soft Skills)
• Data Management and Reporting (Hard Skills)
• Data Extraction and Entry (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary: 

• Be responsible for supporting the clinical studies and for clinical study management especially:
• Prepare the study sites for site initiation, and develop the monitoring plan and related documents.
• Support the regulatory submission process.
• Assist Study Lead with the design and preparation of study-related materials for the training of CRO staff
• Assist Study Lead with oversight of study vendors (CRO, Drug Supply, Central Lab)
• Perform remote query and data review as needed to assist CDM
• Assist clinical finance and study lead with the review, tracking and management of study-specific budgets
• Coordinates and assists in the preparation of progress reports to appropriate Investigational Review Boards within the prescribed timeframe.
• Maintain well-organized and accurate paper and electronic documents recording all subjects’ demographic, testing and training information as well as all other source documents related to the ongoing research.
• Alert the principal investigator of significant findings and events.
• Conduct site initiation, monitoring, and site closure, ensuring the documentation is maintained.
• Support the development of a patient enrolment plan and investigate patient enrolment delays.

Skills on Resume: 

• Clinical Study Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Training and Support (Soft Skills)
• Vendor Oversight (Hard Skills)
• Data Review and Query Management (Hard Skills)
• Budget Management (Hard Skills)
• Documentation and Reporting (Hard Skills)
• Patient Enrollment Planning (Hard Skills)

Job Summary: 

• Assist in start-up, management, and close-out activities for clinical studies
• Attend oversight monitoring visits as required per the Sponsor Oversight Plan and/or Clinical Monitoring Plan
• Review Visit Reports from the CRO, escalating monitoring trends or findings
• Attend study qualification, initiation, monitoring and close-out visits
• Track metrics related to enrollment and other activities as specified in Sponsor Oversight and Clinical Monitoring Plans
• Review study data (electronic data capture and listings/tables) for trends, anomalies, or protocol deviations
• Collaborate closely with Concentric study management, CRO study managers, and CRO staff
• Review site/patient activity tracking, prepare study updates and proactively identify and solve study-related issues
• Review and provide input to study site documents and study plans, including study monitoring plans, data management plans, eTMF plans, etc.
• Prepare Investigational Product (IP) release forms and work closely with PharmOps to ensure adequate and timely delivery of IP to clinical sites
• Lead or assist with central lab vendor to support PK activities - supplies and shipment logistics for clinical sites
• Lead or assist with CRO eTMF processes - set-up, QC, management, and delivery of eTMF.

Skills on Resume: 

• Clinical Study Management (Hard Skills)
• Monitoring and Oversight (Hard Skills)
• Data Review and Analysis (Hard Skills)
• Collaboration and Communication (Soft Skills)
• Documentation and Planning (Hard Skills)
• Investigational Product Management (Hard Skills)
• Vendor Management (Hard Skills)
• eTMF Processes (Hard Skills)

Job Summary: 

• Communicate and collaborate with key players, and internal and external staff.
• Check in regularly with the manager and complete assignments by the agreed deadline.
• Document process and provide regular updates.
• Proactively seek methods of improvement, of individual work and project outcomes.
• Proactively work to streamline workflows, and build efficiency and user interface of various platforms.
• Demonstrate a thorough understanding of sponsor SOPs, protocols, monitoring plans, and other documents and processes required to manage clinical trial sites
• Demonstrate ability to manage multiple protocols simultaneously
• Demonstrate ability to juggle many priorities and report to multiple study leads
• Provide assistance, where directed by managers, in tasks related to protocol and ICF-related documents
• Assist with the preparation of regulatory submissions
• Assist clinical sites with IRB/IEC submissions and ensure collection of required essential documents for study start-up and throughout the conduct of the study.
• Maintain effective communication with other members of the clinical team and management.

Skills on Resume: 

• Effective Communication and Collaboration (Soft Skills)
• Time Management and Deadline Adherence (Hard Skills)
• Documentation and Process Management (Hard Skills)
• Process Improvement and Workflow Optimization (Hard Skills)
• Understanding of Clinical Trial Procedures (Hard Skills)
• Regulatory Knowledge and Compliance (Hard Skills)
• Project Management and Multitasking (Hard Skills)
• Interpersonal Skills and Team Coordination (Soft Skills)

Job Summary: 

• Performing site visits and monitoring activities by protocol, GCP/ICH Guidelines and other applicable requirements,
• Ensuring overall integrity of study and adherence to guidelines, protocol, and regulations,
• Taking an active role in the project team by providing feedback and suggestions for successful completion of the project
• Leading, coaching and mentoring the CRA team to assist in their development and training,
• Responsible for execution of KPIs for assigned staff and for all site deliverables within the required time and budget
• Providing leadership for the development and implementation of new training programs and improvement of current programs for assigned staff.
• Oversee safety reporting, track study-reported adverse events, write safety narratives and coordinate safety reviews.
• Support Clinical Study Coordinator as needed (contracts, TMF, invoices, etc).
• Assist in the development of study documents, such as informed consent forms, study logs, and study manuals
• Participate in database User Acceptance Testing
• Document and maintain training throughout the trial.
• Take responsibility for performing drug accountability.

Skills on Resume: 

• Clinical Monitoring Expertise (Hard Skills)
• Project Leadership and Team Collaboration (Soft Skills)
• Staff Development and Mentorship (Soft Skills)
• KPI Management (Hard Skills)
• Training Program Development (Hard Skills)
• Safety Reporting and Adverse Event Tracking (Hard Skills)
• Study Document Management (Hard Skills)
• Database Testing and Drug Accountability (Hard Skills)

Job Summary: 

• Prepare for and conduct qualification, initiation, monitoring, and closeout visits at clinical sites in compliance with the approved protocol and monitoring plan.
• Completion of monitoring reports and follow-up letters, which include providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
• Ensure quality of trial data through in-house review of electronic CRF data and on-site and remote source document verification.
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment and staff.
• Ensure clinical trial sites are audit-ready and be prepared to assist actively in an inspection by Health Canada or another regulatory body at the clinical study site.
• Effectively monitor approximately 4-6 clinical study sites.
• Act as the main line of communication between the sponsor and trial site personnel including, the investigator, physician, therapists, coordinator, and other site personnel.
• Meticulously track study progress and offer solutions for issues that arise.
• Escalation of site issues through the proper channels of communication.
• Lead meetings with sites provide meeting notes and follow through on action items.
• Verify that the investigator adheres to the protocol and complies with all regulatory standards including ICH GCP, FDA, IRB, and other pertinent regulatory agencies.
• Maintain familiarity with local regulatory requirements, MAPS PBC SOPs, guidelines, and ICH GCP.

Skills on Resume: 

• Clinical Trial Monitoring (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Data Quality Management (Hard Skills)
• Communication Skills (Soft Skills)
• Issue Resolution and Escalation (Soft Skills)
• Documentation and Reporting (Hard Skills)
• Training and Resource Verification (Hard Skills)
• Meeting Leadership and Follow-Up (Soft Skills)

Job Summary: 

• Review and manage the enrollment process at clinical trial sites.
• Collate, file and track documentation for the Trial Master File using Montrium eTMF.
• Identify, track, and resolve any data queries/protocol deviations throughout the trial.
• Ensure AEs, SAEs, reactions, concomitant medications, and intercurrent illnesses are reported following the protocol in the source, eCRFs, and the SAE Database.
• Ensure timely reporting of important AEs, Adverse Events of Special Interest, and SAEs.
• Track study progress using tracking tools (deviation logs, decision logs, SmartSheet, etc.), ensuring timely and quality updates.
• Communicate deviations from the protocol, SOPs, ICH GCP, and the applicable regulatory requirements to management, as appropriate.
• Ensure all unused trial supplies are accounted for.
• Ensuring each site has the trial materials and training the site staff to trial-specific industry standards.
• Regularly review study data and assist with cleaning and locking clinical trial databases.
• Collect, manage, file and archive all study documentation and correspondence.
• Assist the team in preparing final reports.

Skills on Resume: 

• Clinical Trial Management (Hard Skills)
• Documentation and Data Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Communication Skills (Soft Skills)
• Training and Support (Soft Skills)
• Data Analysis and Reporting (Hard Skills)
• Tracking and Monitoring (Hard Skills)
• Organizational Skills (Soft Skills)

Job Summary: 

• Interfaces with clinical sites/investigators on and off-site as part of administrative site management to ensure compliance with protocols and regulatory
• Conduct site qualification, initiation visits, on-site monitoring visits, co-monitoring visits, and site closure visits of all phases of clinical trials.
• Assist with the resolution of data queries.
• Write site visit reports or review monitoring reports provided by Contract Research Organizations (CROs).
• Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by providing site training, guidance of investigators and site study team, and follow-up of corrective
• Ensure International Conference on Harmonization, and Good Clinical Practice procedures are followed in all study
• Review study data for completeness, accuracy, and consistency with the study
• Lead all aspects of study site monitoring according to GCP, and ICH guidelines
• Partner with investigators and study coordinators on pre-study qualification and site initiation visits
• Conduct routine study site monitoring visits
• Close-out clinical sites, and ensure study files are up to date to maintain the success of the study
• Ensure timely subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel to complete study

Skills on Resume: 

• Site Management and Compliance (Hard Skills)
• Clinical Trial Monitoring (Hard Skills)
• Data Query Resolution (Hard Skills)
• Report Writing and Review (Hard Skills)
• Training and Guidance (Soft Skills)
• Study Data Review (Hard Skills)
• Leadership and Coordination (Soft Skills)
• Documentation and File Management (Hard Skills)