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 reporting forms. Documents, records and assimilates accurate participant records and study records to ensure documentation c... more details
Essential Functions
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 reporting forms.
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.
Establish and maintain communications with Investigator, Sponsor and internal constituents.
Compiles and assists in analyzing and interpreting data in preparation for a presentation, sponsor/regulatory agency, publication, etc.… with the assistance of project investigator.
Responsible for the handling, packaging, and shipping of dangerous goods under supervision and in compliance with State and Federal regulations. These specimens may include tissue, blood, dry ice, and chemicals. Certification in these procedures is required in accordance with the Federal Regulations. Knowledge of good clinical practice for the handling of specimens and blood may be required.
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
Doctorate Degree Preferred
Work Experience
2 years related experience Required
Knowledge, Skills, & Abilities
Experience in team setting. Preferred
Experience in IND filings, NDAs and 510(k) filings. Preferred
Ability to prioritize the work of multiple projects. Required
Knowledge of Good Clinical Practice and Good Technology Practice. Required
Detail-oriented person with the ability to collect, compile, and analyze information. Required
MS Word, Excel, PowerPoint, RedCap Required
Ability to understand and communicate research protocol requirements to others. Required
Able to work independently on multiple tasks and manage time effectively. Required
Medical terminology. Required
Excellent verbal, written and communication skills. Required
Computer skills: Excel, Access and Word. Required
Licenses and Certifications
Certified Clinical Research Coordinator (CCRC) Preferred
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