Description
Coordinate and execute clinical research studies, ensuring adherence to protocols, regulations, and study objectives. Manage participant activities and study logistics, support investigators and study teams, and collect, evaluate, and report clinical data.
- • Support site feasibility and sponsor outreach for industry-sponsored trials.
- • Stay current by reviewing literature and attending continuing education, conferences, and seminars.
- • Register enrolled subjects with required coordinating or statistical centers.
- • Prepare for and participate in sponsor, regulatory, and quality assurance audits.
- • Assist in preparing and managing study budgets and disbursements.
- • Perform protocol procedures such as interviews, vital signs, and electrocardiograms.
- • Interpret protocols and communicate dose or treatment modifications to clinicians per protocol.
- • Develop or coordinate recruitment and advertising materials.
- • Coordinate with sponsors and vendors to meet equipment and software specifications.
- • Confer with healthcare professionals to optimize recruitment strategies.
- • Track enrollment and document screen failures, dropouts, and contact attempts.
- • Review protocols for operational feasibility, sample handling, data plans, and subject risks.
- • Record adverse events and consult investigators on reporting to oversight bodies.
- • Prepare protocol worksheets, procedural manuals, adverse event reports, IRB submissions, and progress reports.
- • Contribute to the development of protocols, administration guidelines, and data collection procedures.
- • Coordinate enrollment and obtain and document informed consent.
- • Order and manage study drugs or devices per protocol.
- • Organize space and logistics for study equipment and supplies.
- • Liaise with sponsors to schedule site visits and resolve data queries.
- • Train staff on study procedures, standards of care, informed consent, and documentation.
- • Educate subjects and caregivers on study expectations and potential outcomes.
- • Identify protocol issues and assist investigators with resolution and amendments.
- • Dispense study drugs or devices and calculate doses per protocol and licensure.
- • Coordinate specimen requisition, collection, labeling, storage, and shipment.
- • Obtain follow-up information by communicating with outside providers and subjects.
- • Communicate laboratory findings with investigators and relevant teams.
- • Collaborate with investigators on study reports and presentations.
- • Code, enter, and interpret study data for accuracy and completeness.
- • Screen and assess subject eligibility via interviews, record reviews, and clinician discussions.
- • Arrange study visit sites and confirm staffing and equipment availability.
- • Schedule subjects for visits, procedures, and admissions per protocol.
- • Monitor study conduct for compliance with protocols, IRB requirements, and local, state, and federal regulations.
- • Maintain case report forms, drug accountability, and regulatory records.
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
