W2 or 1099 experienced CRC candidates for 40 hours a week 12 month project possible chance of extension
Job Summary:
We are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our dynamic research team. The ideal candidate will be responsible for overseeing and coordinating clinical trials and research studies according to regulatory guidelines and study protocols. The position requires excellent communication skills and a passion for clinical research.
Key Responsibilities:
- Coordinate and manage clinical trials in compliance with study protocols, GCP, and applicable regulatory guidelines.
- Serve as the primary point of contact for study participants, investigators, and external sponsors.
- Recruit, screen, and enroll eligible patients into clinical trials.
- Obtain informed consent and ensure that study participants are fully informed about the study protocol and requirements.
- Monitor study participants' progress, including data collection, and report any adverse events or deviations from the protocol.
- Maintain accurate and up-to-date study documentation, including case report forms (CRFs), regulatory binders, and patient files.
- Schedule and facilitate study-related appointments, procedures, and follow-ups.
- Coordinate with study sponsors and clinical monitors during site visits and audits.
- Ensure proper handling, storage, and shipping of study samples, including biological specimens.
- Track study supplies, including medications, lab kits, and devices.
- Ensure that all study-related activities are conducted in compliance with institutional, state, and federal regulations.
- Assist the Principal Investigator in the preparation of research-related reports and presentations.
- Participate in study start-up meetings and site initiation visits.
Qualifications:
- Education: Bachelor's degree in healthcare, life sciences, or a related field. (Master’s degree or RN license preferred)
- Experience: Minimum 2-3 years of experience coordinating clinical research trials or studies.
- Certifications: CCRC (Certified Clinical Research Coordinator) or equivalent certification preferred.
- Skills:
- Strong understanding of clinical research protocols, GCP (Good Clinical Practice), and IRB regulations.
- Proficiency with clinical trial management software (CTMS) and electronic data capture systems (EDC).
- Excellent organizational and time management skills.
- Strong communication and interpersonal skills, with the ability to work effectively in a multidisciplinary team.
- Attention to detail and problem-solving ability.
- Ability to handle confidential information with discretion.
