Job Description: Clinical Research Coordinator

Position Title: Clinical Research CoordinatorLocation: Flint, MI 

Job Summary:

We are seeking a detail-oriented and dedicated Clinical Research Coordinator (CRC) to manage and oversee clinical trials and research studies from initiation to completion. The CRC will support investigators in the coordination of clinical research activities, ensuring compliance with regulatory requirements, patient safety, and the integrity of clinical data. This position requires excellent communication skills, strong organizational abilities, and experience in clinical research settings.

Key Responsibilities:

• Study Coordination:

  • Assist in the design and implementation of clinical trial protocols.

  • Schedule and manage patient recruitment, enrollment, and screening for clinical studies.

  • Obtain informed consent from study participants and ensure full understanding of the trial procedures.

  • Monitor patient progress, adherence to study protocols, and manage any adverse events or side effects.

  • Coordinate and oversee study visits, ensuring the correct scheduling and documentation of all clinical visits and procedures.

• Regulatory Compliance:

  • Ensure that all activities comply with federal, state, and local regulatory guidelines, including ICH-GCP (Good Clinical Practice), FDA, and HIPAA.

  • Maintain up-to-date documentation for all study activities, including patient charts, medical records, and regulatory files.

  • Assist with the preparation of IRB (Institutional Review Board) submissions and study documents.

  • Ensure that the study site follows all sponsor-specific protocols and procedures.

• Data Management:

  • Collect, organize, and review clinical data for accuracy and completeness.

  • Ensure proper documentation of patient progress, test results, adverse events, and other relevant clinical information in the study database.

  • Assist in preparing data for analysis and reports for the sponsor, IRB, or other oversight bodies.

• Patient and Study Team Interaction:

  • Serve as the main point of contact for patients, ensuring their questions are addressed and their participation is supported throughout the study.

  • Communicate effectively with investigators, research staff, and external stakeholders to ensure smooth execution of clinical trials.

  • Provide ongoing patient education about study protocols, safety procedures, and the importance of compliance.

• Safety and Quality Assurance:

  • Monitor patient safety and study protocol adherence, reporting any deviations or adverse events to the appropriate authorities.

  • Review study documentation regularly for completeness and quality, ensuring that regulatory and protocol requirements are met.

  • Participate in site audits and inspections, assisting with corrective actions as necessary.

• Study Logistics and Supplies:

  • Maintain inventory of study-related supplies and ensure the timely ordering and management of necessary materials and medications.

  • Oversee the storage and handling of study-related drugs or biologics as per clinical trial guidelines.

Qualifications:

• Education:

  • Bachelor’s degree in Life Sciences, Nursing, or a related field.

  • Clinical Research Coordinator (CRC) certification from a recognized accrediting body (e.g., ACRP, SoCRA) preferred.

• Experience:

  • Experience in clinical research, preferably in a clinical trial setting or academic research environment.

  • Familiarity with clinical trial protocols, GCP guidelines, and regulatory requirements (FDA, ICH, HIPAA).

• Skills:

  • Strong organizational and time-management skills.

  • Excellent written and verbal communication skills.

  • Ability to work independently and as part of a team in a fast-paced, deadline-driven environment.

  • Proficiency with clinical trial management software (CTMS), Microsoft Office, and other relevant software tools.

• Certifications:

  • Clinical Research Coordinator (CRC) certification is a plus.

  • Good Clinical Practice (GCP) certification preferred.

• Other:

  • Strong attention to detail and commitment to maintaining confidentiality.

  • Ability to manage multiple tasks and priorities.

  • Flexibility and adaptability in a dynamic work environment.