Clinical Research Coordinator (CRC)-FT

Clinical Research Coordinator II

The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Responsibilities:

• Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
• Develop draft source documents and review the documents for accuracy and clarity prior to study start up.
• Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.
• Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
• Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.
• Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
• Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.
• Contribute to the SOP review and development as delegated by the Site Director.

Study Management:

• Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
• Attend the investigator meeting for each assigned protocol, as appropriate.
• Completion of IRB study renewals and maintain copies of all IRB communications.
• In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
• Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
• Review and obtain informed consent from potential study volunteers.
• Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.
• Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.
• Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
• Ensure timely and accurate CRF completion for each study subject.
• In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
• Outcome of enrollment and sponsor monitoring visits of all assigned protocols
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.

Skills and Qualifications:

• Education and experience
  • High School Diploma or its equivalent; College degree preferred.
  • Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.
  • Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
  • Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
• Requirements
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Excellent communication skills (interpersonal, written, verbal)
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)