Clinical Research Coordinator 3

Company Highlights:

*Fast growing clinical research site network

*Opportunities for growth and promotion

*Great benefits and culture!

Position: Clinical Research Coordinator III (Full-Time/Non-Exempt)

CRC-III is the most senior clinical research coordinator at our client. They are responsible for the overall management of a high volume of studies including administrative duties and regulatory functions. The CRC III is responsible for clear and direct communication with study sponsor, study monitor, CRO, PI and site manager. Adherence to their SOPs is required. The CRC-III mentors and trains both CRC-I and CRC-II roles and is a resource for high level problem solving and planning of clinical trials. The CRC-III should require minimal direct oversight, fully owning all assigned clinical trials from startup to closeout and meeting enrollment goals. It is the responsibility of the CRC III to represent himself/herself and the site in the most professional, ethical and positive manner.

Reports to: Site Manager

Job Description:

• Meet enrollment of clinical trials according to protocols, identifying ways to exceed enrollment goals.
• Confer with the recruitment department and site management to determine the best recruitment practices for assigned studies.
• Inform study participants or caregivers about study procedures
• Train study team members and monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies
• Have all source documentation completed while the patient visit is occurring and while the patient is on site for optimal accuracy and completeness of data collection. Apply relevant good documentation practices.
• Data collection: all source documentation completed and entered into EDC within one business day of patient visit. Ensure data queries are resolved in the EDC within 48 hours of query being issued
• Know the contents of and maintain assigned study e-regulatory binders, self-check all binders for compliance and forward any missing documentation to binders regularly.
• Follow all client work instructions, guidelines, policies, and controlled documents, assist CRC-Is as needed by providing guidance on following and applying these documents.
• Scheduling of study visits and monitoring schedules according to protocol and study plan
• Prepare study participants source documents prior to patient visit
• Inventory lab and study supplies. For assigned studies maintain an acceptable threshold of supplies required to complete study visits and meet site enrollment goals.
• Attend investigator meetings with principal investigator, ask questions, and collect pertinent study information while at any investigator meeting
• Attend site initiation visits from various drug sponsors and conduct site initiation tours
• Ensure maintenance of required records of study activity including case report forms, drug dispensation records
• Identify, report, and problem solve protocol deviations or unanticipated events.
• Drug Accountability: Logging investigational product shipments and reporting received as required. Thorough documentation if lost or damaged. Logging dispensed medication to subjects in appropriate medication log as required per study protocol.
• Ensure maintenance of accurate master logs for each study. (i.e., ICF, patient ID, and enrollment logs).

Required Skills/Abilities:

• Experience leading a high volume of clinical trials as lead CRC required
• Ability to work independently and as a member of a team
• Ability to train and guide staff effectively and knowledgeably
• Effective verbal and written communication skills
• Ability to read, write, and speak English language
• Knowledge of high-level medical terminology
• Ability to travel to assist & train at our client’s sites

Education and Experience:

• GED or HS Diploma required (Some College preferred)
• 4 years clinical research experience required
• Phlebotomy if required by state law