Job Details

Position Summary
The clinical research coordinator is primarily responsible for coordinating research patient visits according to ICH-GCP guidelines, and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.
 
Essential Functions

• Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
• Conducts and/or participates in the informed consent process/discussion with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places per the research SOP. Assures that amended consent forms are appropriately implemented and signed respectively.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility accurately.
• Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Coordinates patient visits as assigned by research manager.
• Performs sample collection per the protocol. Processes samples per the protocol and lab manual guidelines for each study.
• Registers each participant in the electronic data capture (EDC) to ensure billing of study procedures to the appropriate funding source.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms, paper or electronic. Must be attentive to data queries and resolve them within the required timeframe.
• Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals.
• As delegated by research manager, collects documents needed to initiate the study for sponsor submission (e.g., FDA Forms 1572, CVs, medical licenses, IRB applications, etc.).
• Maintains adequate inventory of study supplies. If handling investigative drugs/devices, follows the sponsor protocol on Investigative Drug/Device Accountability.
• Documents date of training and signatures of study staff on study specific training log.
• Creates source documents for data capture per study protocol and manual of procedures.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
• Coordinates monitor site visits and assists with preparation of site visit documentation.
• Maintains CVs and training materials per protocol.
• Assist patients with insurance coverage of medication if not covered by sponsor.
• Attends teleconferences and Investigator Meetings as requested by research director.

 
 
Job Skills, Education and Experience

• Knowledge and experience in coordinating clinical trials is required.
• Certified Clinical Research Coordinator or Professional (CCRC/CCRP) is preferred.
• Must have excellent organizational skills to independently manage work flow.
• Meticulous attention to detail is required.
• Must be able to take self-motivate and take initiative.
• Must be energetic with the ability to prioritize quickly and multi-task.
• Must have excellent communication skills; both personal and written.
• Must have an excellent teamwork attitude.
• Must demonstrate aptitude for developing new skills.
• Proficiency in Microsoft Office (Word, Excel, Outlook) is preferred.
• Experience with processing laboratory samples is preferred.