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Clinical Trials Coordinator
2 months ago
GENERAL SUMMARY:
The Clinical Trials Coordinator plays a pivotal role in assisting the Principal Investigator in managing behavioral pharmacological studies and imaging/biomarker trials. This position involves adhering to study protocols, which includes participant recruitment, scheduling appointments, ensuring the completion of study visits, and maintaining accurate data collection and entry. The Coordinator also engages with regulatory bodies for both local and multicenter trials, and is responsible for making independent assessments regarding the eligibility of potential study participants.
KEY RESPONSIBILITIES:
- Facilitates and supports scientific research initiatives.
- Coordinates the execution of clinical research studies, both internally and externally.
- May design and interpret scientific research protocols, including data collection systems and securing institutional review board (IRB) approvals.
In addition, the Coordinator will:
- Establish and maintain communication with study participants, screening applicants to ensure they meet the necessary criteria for participation.
- May conduct clinical assessments such as phlebotomy, EKGs, and structured interviews, as well as administer study-related behavioral questionnaires.
- Collaborate with the Principal Investigator and/or Research Manager to develop and implement effective patient recruitment strategies.
- Organize and maintain the study database, ensuring data validation and quality control.
- Explore and develop innovative methods and technologies to advance research efforts.
- Contribute to scientific literature through reports, journals, and presentations, including conducting literature searches as needed.
- Oversee the work of research assistants, providing training and orientation to new staff members.
- Perform other research and administrative tasks as assigned by the Principal Investigator.
ADDITIONAL DUTIES:
The Clinical Trials Coordinator II will also:
- Maintain comprehensive research data, regulatory binders, and study databases.
- Conduct data analysis and quality assurance checks.
- Organize and interpret research data.
- Act as a resource for patients and their families regarding study-related inquiries.
- Monitor and evaluate laboratory and procedural data.
- Assist in the preparation of annual reviews and study reports.
REQUIRED SKILLS AND COMPETENCIES:
- Meticulous attention to detail.
- Strong organizational capabilities.
- Effective communication skills.
- Proficiency in computer applications.
- Familiarity with clinical research protocols.
- Respect for participants' rights and individual needs.
The ideal candidate will demonstrate the ability to work both independently and collaboratively, possess analytical skills to resolve technical issues, and have a solid understanding of data management programs.
WORKING CONDITIONS:
This role involves working in an office environment, engaging with researchers across various locations, and traveling between hospital and research facilities while managing study materials.
SUPERVISORY RESPONSIBILITIES:
The Clinical Trials Coordinator is responsible for training and orienting new staff and may take on a leadership role in smaller research settings.