Clinical Research Coordinator facilitates on-site and remote clinical studies. Ensuring adherence to protocols and managing study activities including recruitment and data management.
Responsibilities
Coordinates, supports and facilitates on site, as well as at 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
Responsible for data management and integrity ensuring that the transfer of the data from the source documents and laboratory reports to a data template and case report form, if needed, is completed in a timely manner
Assists with the collection of data, correspondence and submissions 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 per SOPs
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.)
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
Experienced with data extraction including gathering, cleaning and formatting data from multiple sources
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
Tech savvy, proficient in Microsoft Office Suite
Excellent written and verbal communication skills
Utilizes discretion in handling confidential information
Detail-oriented and ability to work in a fast-paced environment
Benefits
Flexibility to travel outside of the facility to recruit potential subjects (i.e., physician offices, health fairs, expos etc.)
2 onsite days per week is an essential function of this position after completion of the introductory period
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