Clinical Research Coordinator

Core Duties and Responsibilities:

• Coordinate, support, and facilitate on site, as well as in home (remote) clinical studies in strict accordance with approved protocols.
• Conducts research in accordance with Good Clinical Practice (GCP), Life Extension Clinical Research Standard Operating Procedures, Policies and Work Instructions as well as applicable local, state, and federal regulations.
• Assists in the recruitment, appointment scheduling, consenting, enrolling, and conducting of the study visits while adhering to the project timelines.
• Active role in successfully recruiting and enrolling participants for clinical studies.
• Performs clinical tasks including but not limited to, managing study products, laboratory specimen storage/shipment, adverse event documentation and reporting in a timely manner.
• Responsible for data management and integrity ensuring that the transfer of the data from the source documents and laboratory reports to the data template and case report form is completed in a timely manner.
• Keeps track and initiates the process for subject payments.
• Assists with the correspondence to the Institution Review Board (IRB) and other regulatory agencies, as needed.
• Assists in the study product(s) dose preparation, ensures study product is received, inventoried, and stored securely; assists with dispensing study product(s) with proper documentation.
• Facilitates study close out activities and retains records/archives documents, as required.
• Reports any deviations from the protocol and any quality or subject safety concerns to the Supervisor, Clinical Research/Director
• Maintains and orders office/medical supplies and paperwork, as needed.
• Flexibility to travel outside of the facility to recruit potential subjects (i.e., physician offices, health fairs, expos etc.), delivers study product to outside sites as well as provides monitoring services for Life Extension sponsored clinical studies, as needed.
• Regular onsite attendance is an essential function of this position.
• Other duties and responsibilities as assigned.

Position Requirements:

• 4-year college degree or equivalent
• 1+ years’ experience working with clinical trials required.
• Comfortable working with subjects participating in person as well as remotely.
• Flexible schedule, including occasional Saturdays. Willing to adjust working hours for the effective execution of studies.
• Working knowledge of Microsoft Office Suite and able to learn clinical research software programs including clinical trial management systems and electronic data capture.
• Having excellent written and verbal communication skills
• Utilizes discretion in handling confidential information
• Detail-oriented and ability to work in a fast-paced environment; ability to properly handle interruptions.
• Able to visualize objects closely required (e.g., reading thermometers)
• Able to do a variety of physical exertion with some and/or continuous standing or walking, for example in health fairs or giving presentations.
• Able to work both autonomously and as part of a team.