Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials. Essential Functions. Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2)Performs all activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtains informed consent, educate... more details
Position Summary
Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials.
Essential Functions
Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2)
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). (20%; Competency 1, 2)
Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (10%; Competency 1, 2)
Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies. (20%; Competency 1, 2)
Assists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings. (10%; Competency 2,3)
Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%; Competency 1, 2)
Mentorship of the clinical research process to the junior clinical research staff. (10%; Competency 3)
Performs other related duties as assigned or required. (10%; Competency 1, 2, 3)
Required For All Jobs
Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Qualifications Education
Bachelor's Degree Required
Work Experience
2 years clinical research experience Required and
Experience in a team setting Required
Knowledge, Skills, & Abilities
Ability to prioritize the work of multiple projects. Required
Knowledge of GCP and FDA guidelines. Required
Knowledge of Electronic Data Capture Programs. Required
Medical & Research Terminology. Required
DOT/IATA Training Preferred
Ability to train and mentor junior staff. Required
Detail-oriented person with the ability to collect, compile, and analyze information. Required
Ability to understand and communicate research protocol requirements to others. Able to work independently on multiple tasks and manage time effectively. Required
Demonstrates customer service excellence with internal and external customers Required
Excellent verbal, written, interpersonal and communication skills. Required
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