Key Responsibilities:
Coordinate daily operations of research studies from feasibility through closeout.
Act as liaison between site personnel, sponsors, and supervisors.
Collaborate with finance, hospital administration, and IRB (if applicable).
Schedule and track assessments and study milestones.
Ensure proper informed consent and adherence to protocol and regulatory standards.
Enter and verify clinical data in Case Report Forms or electronic systems.
Create source documentation tools when not provided by sponsors.
Monitor and report adverse events, protocol deviations, and waivers.
Manage study supplies, including drug and device shipments.
Attend investigator meetings, site visits, audits, and training sessions.
Respond to monitoring and audit findings.
Education & Experience:
Required: Bachelor's degree and 1 year of relevant research experience (or equivalent).
Preferred: Certified Clinical Research Coordinator (CCRC).
Knowledge, Skills & Abilities:
Knowledge:
Basic clinical research operations, ICH-GCP guidelines, and federal regulations.
Understanding of medical terminology and internal SOPs.
Abilities:
Strong attention to detail, self-motivation, and interpersonal skills.
Ability to manage multiple tasks in a regulated environment.
Clinical Competencies:
Annual demonstration of clinical skills (e.g., ECG, specimen processing) may be required. Training and certification will be provided as necessary per protocol.
Travel Requirements:
Occasional Travel (up to 25%)
No Travel
50% or more
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Clinical Research Coordinator (Onsite) • Attn: Pauline Matheri, Building C, Plano, TX, US