Job Description

The Clinical Research Coordinator provides comprehensive support to the Research Department. In this role, you will be responsible for participant recruitment, complex data management, and the hands-on collection and processing of clinical specimens. You will play a vital role in ensuring that all research activities are conducted with strict adherence to study protocols, FDA guidelines, and standard operating procedures.

Minimum qualifications:

• Education: Bachelor’s degree or 4 years of equivalent experience in a clinical research setting.
• Experience: 2 years of experience in a healthcare-related position.
• Technical Skills: Previous experience with clinical trials is required. Proficiency with Electronic Medical Record (EMR) systems and Phlebotomy.
• Communication: Strong verbal and written communication skills with the ability to interact effectively with patients and healthcare professionals.

Preferred qualifications:

• Previous phlebotomy experience
• Experience specifically within pharmaceutical trials.
• Proficiency in Microsoft Office Suite.
• Demonstrated ability as a self-starter who takes initiative in a fast-paced environment.
• Certification or training in specialized diagnostic tools (e.g., Fibroscans).

Responsibilities:

Clinical & Laboratory Operations

• Perform phlebotomy and collect, process, and ship blood, urine, and stool specimens in accordance with patient visit schedules.
• Assist with clinical tasks including taking vital signs and performing Fibroscans (following training).
• Maintain laboratory integrity by monitoring temperature logs, ordering dry ice, and managing clinical supply expiration dates.

Data Management & Compliance

• Complete and maintain Case Report Forms per FDA guidelines, ensuring 100% accuracy against medical records.
• Organize research files and enter data from source documents into study databases.
• Conduct routine data verification and quality control to ensure data integrity and protocol consistency.
• Ensure all regulatory documents are filed and maintained according to SOPs.

Patient & Study Coordination

• Support subject recruitment through chart reviews, cold calling, and patient outreach.
• Schedule patient visits and coordinate the notification of participation to referring physicians.
• Prepare source documents and submit patient stipends or reimbursement requests post-visit.
• Provide general administrative support to ensure the smooth daily operation of the Research Department.

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