Job Description

Clinical Research Coordinator - Job Description

The Clinical Research Coordinator (CRC) is responsible for overseeing and managing the daily operations of clinical research studies. This role involves working closely with clinical teams, investigators, and study participants to ensure that all research activities are performed in compliance with protocol guidelines, regulatory requirements, and ethical standards.

Key Responsibilities:

• Study Management: Organize, plan, and coordinate all aspects of assigned clinical trials from start to finish.

• Meetings & Communication: Attend investigator meetings, site initiation meetings, and other relevant study-related meetings.

• Recruitment & Enrollment: Collaborate with the recruitment team for participant screening and enrollment. Ensure all protocol and regulatory requirements are met during the process.

• Informed Consent & Study Visits: Conduct informed consent processes with participants, ensure full understanding, and manage study-related visits.

• Monitoring: Monitor and assess study subjects in accordance with protocol requirements. Maintain regular checks on their health and safety.

• Adverse Event Reporting: Identify, monitor, and report any adverse events per the protocol.

• Documentation & Data Entry: Maintain accurate and detailed records, including source documentation, case report forms, and drug dispensation records. Enter data into relevant systems and manage study databases.

• Test Article Handling: Dispense test articles (medications, devices, etc.), calculate dosages if required, and provide instructions to participants.

• Case Report Forms & Query Resolution: Complete and verify case report forms, resolve any queries, and ensure accurate reporting.

• Protocol Deviations: Report protocol deviations to the Principal Investigator (PI), sponsor, and Institutional Review Board (IRB) as necessary.

• Specimen Management: Collect, process, and ship study-related specimens as required.

• Phlebotomy: Perform blood draws and handle biological samples in accordance with study protocols and safety guidelines.

• Team Support: Provide assistance and mentorship to fellow study coordinators when needed.

• Quality Assurance: Ensure quality assurance for study protocols and activities are in compliance with Standard Operating Procedures (SOPs).

• Confidentiality: Ensure participant confidentiality and adhere to ethical guidelines and regulations regarding sensitive information.

• Additional Duties: Perform other duties as assigned and assist in occasional outreach community events related to clinical trials.

Additional Responsibilities:

This job description is intended to outline the primary responsibilities of the Clinical Research Coordinator; however, additional duties and tasks may be assigned as needed to support the research program or the needs of the organization. These additional responsibilities are not limited to the above and may evolve over time based on the requirements of the study or operational needs.

Knowledge, Skills, and Abilities:

• Leadership & Communication: Strong leadership skills with the ability to communicate effectively with study teams, participants, and external stakeholders.

• Organization & Multitasking: Exceptional organizational skills, with the ability to manage multiple tasks and prioritize effectively in a fast-paced environment.

• Attention to Detail: High level of accuracy and attention to detail, ensuring all protocol requirements and regulations are strictly followed.

• Team Collaboration: Ability to work collaboratively within a multidisciplinary team, as well as independently when required.

• Operational Efficiency: Strong time management skills, able to use time productively to ensure high levels of operational efficiency and effectiveness.

• Confidentiality: Ability to maintain strict confidentiality in handling sensitive participant data and study-related information.

• Technical Proficiency: Proficient in using office equipment (phone, computer, fax, copier) and study-specific tools or software.

Required Experience and Qualifications:

• Educational Background: Bachelor’s degree in a related field.

• Preferred Qualifications: Medical certification or license such as MS, LPN, RN, or other relevant healthcare certifications.

• Experience: 2 Years of previous experience in clinical research or clinical trial management is required.

• Phlebotomy Experience: Prior experience in performing blood draws and handling biological specimens is required.

This position is ideal for someone who is detail-oriented, highly organized, and committed to maintaining high standards of research integrity and participant safety. The Clinical Research Coordinator plays a crucial role in the success of clinical trials and in advancing medical research that benefits public health.

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