Clinical Research Coordinator

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.
• Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
• 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 direct oversight from Site Director, 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.
• Contribute to the SOP review and development as delegated by the Site Director.
• 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 with directive from Site Director.
• 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 with potential study volunteer
• Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
• Maintain organized, accurate and complete study records
• Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
• Enter data as appropriate for protocol (paper-electronic data capture)
• In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
• Perform study close-out procedures.
• Store study records appropriately

Skills and Qualifications

Education and experience: High School Diploma or its equivalent; College degree preferred. Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology to communicate with physician office and laboratory staff. Demonstrate the initiative to act independently, initiate activity as required and make 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)