Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and or complex clinical research trials.

• Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. Performs all activities related to clinical research studies including but not limited to.
• Screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes case report forms, CRF.
• Responsible for in depth knowledge of protocol requirements and Good Clinical Practice guidelines.
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures and internal and external regulatory agencies.
• Establish and maintain communications with Investigator, Sponsor and internal constituents.
• Mentorship of the clinical research process to the junior clinical research staff. Performs other related duties as assigned or required.

Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and or complex clinical research trials.

• Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. Performs all activities related to clinical research studies including but not limited to.
• Screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes case report forms, CRF.
• Responsible for in depth knowledge of protocol requirements and Good Clinical Practice guidelines.
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures and internal and external regulatory agencies.
• Establish and maintain communications with Investigator, Sponsor and internal constituents.
• Mentorship of the clinical research process to the junior clinical research staff. Performs other related duties as assigned or required.

• Bachelor Degree required and at least 2 years of clinical research experience
• Research certification preferred e.g., SOCRA or ACRP.
• Certification in Human Subjects Protection and CTSC cultural competency training, must be obtained within 1 month of hire.
• Experience in a team setting
• Knowledge of GCP and FDA guidelines
• Knowledge of Electronic Data Capture Programs
• Medical & Research Termniology
• DOT/IATA Training Preferred