Clinical Research Coordinator
About The Position
The Clinical Research Coordinator I (non-RN) performs and manages research studies under the medical supervision of the Principal Investigator. The role supports the successful implementation and ongoing management of clinical research studies, with foundational knowledge of clinical research and the ability to perform basic tasks. The primary focus is on entry-level-complexity study designs, including Phase 4 and observational or registry trials, and their associated procedures. The coordinator administratively and clinically manages an average of five clinical trials open to accrual annually and/or an active on-treatment patient volume of 2–10 annually. The coordinator demonstrates working knowledge of the role, applicable regulations, and organizational and departmental policies and procedures. Work is performed in accordance with regulatory requirements and organizational policies. The position also performs other assigned duties and projects. Responsibilities span protocol comprehension and implementation, regulatory compliance and data integrity, and research financial practices. The coordinator supports protocol-based patient care, study procedures, informed consent, safety reporting, investigational product handling, site documentation, monitoring activities, and identification of study budget elements. Some activities are performed under direct supervision.
Requirements
- High school education required.
- Prior research or related medical science experience.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Critical thinking, problem-solving, analysis, decision-making, planning, time-management, and organizational skills; attention to detail and ability to exercise independent judgment.
- Interpersonal effectiveness, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness.
- Ability to handle sensitive and confidential material and emotionally charged matters effectively.
- Good command of English and effective oral, written, and presentation communication skills; ability to listen actively and provide balanced feedback.
- Strong customer focus and ability to foster quality, performance effectiveness, operational excellence, collaboration, partnerships, and positive employee, physician, and community relations.
- Ability to manage time, competing priorities, stress, and professional development; self-motivated and able to work independently with limited supervision.
- Ability to work remotely effectively as required.
- Ability to work effectively in a fast-paced, multi-site environment and manage competing demands from multiple stakeholders and sites.
Nice To Haves
- Some college.
- A second language.
- Prior experience with electronic medical records (EMR).
- Prior experience with clinical trial data entry systems (EDC).
- Prior experience with Clinical Trial Management Systems (CTMS).
Responsibilities
- Coordinate care for patients on clinical research protocols in accordance with GCP and ICH/FDA guidelines and requirements.
- Identify and explain key protocol elements and perform study tasks under direct supervision.
- Conduct protocol feasibility assessments and complete feasibility and site assessment questionnaires.
- Identify and explain inclusion and exclusion criteria and subject identification, prescreening, screening, and re-screening processes.
- Apply knowledge of informed consent form requirements and the essential elements of the informed consent process.
- Review diagnostic tests and related documentation required by the protocol.
- Follow processes for capturing, assessing, determining causal relationships, reporting, and following up on adverse events; document adverse event types under direct supervision.
- Ensure proper storage, dispensing, handling, and destruction of investigational products, and follow procedures for handling compromised products.
- Follow IRB/IEC review, approval, and reporting requirements and maintain site credentials and current GCP documentation and licenses on file.
- Report safety-related subject discontinuations and safety concerns, including AEs, SAEs, and AEs of Interest, to the sponsor and IRB/IEC.
- Collect, record, and report accurate data in accordance with FDA guidelines and review data against the patient's medical record for completeness and accuracy under direct supervision.
- Protect the scientific integrity of data and the rights, safety, and well-being of clinical trial participants.
- Prepare documents for monitoring visits under direct supervision, review monitoring follow-up reports or letters, and complete requested activities.
- Escalate protocol non-compliance issues to the study PI and research department leadership.
- Identify elements of a study budget as they relate to protocol execution.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
