Job Description

Job Description

Job Description

Coordinates, supports and facilitates the daily clinical trials activity and plays a critical role in the conduct of studies . Collaborates with the Clinical Investigators, Clinical Research team to assist in the implementation of the research protocols as well as provide administrative and data collection support.

Core Duties and Responsibilities:

• Coordinates, supports and facilitates 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

• Coordinates routine study activities including recruitment, appointment scheduling, consenting and enrolling of study participants, conducting of the study visits, initiating and keeping track of subject compensation distributed while adhering to the project timelines

• 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
• 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
• Identifies, reports, and provides solutions for preventing any protocol deviations while escalating any quality or subject safety concerns per departmental policy and in adherence to IRB requirements
• Flexibility to travel outside of the facility to recruit potential subjects (i.e., physician offices, health fairs, expos etc.), deliver study products to outside sites as well as provides monitoring services for Life Extension sponsored clinical studies, as needed
• 2 onsite days per week is an essential function of this position after completion of the introductory period
• 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
• Demonstrated ability and understanding of clinical study subject recruitment, selection and enrollment.
• Flexible schedule, including occasional Saturdays; Willing to adjust working hours for the effective execution of studies
• Working knowledge of Microsoft Office Suite and ability to learn clinical research software programs including clinical trial management systems and electronic data capture
• 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

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