Coordinates the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
- Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
- Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
- Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
- Recognizes, tracks and reports adverse events and protocol deviations.
- Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
- Represents the research program at meetings, national and international research consortia.
- Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
- Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
- Supervises, mentors and trains new or junior research staff.
- Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
- Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
- Assists the Principal Investigator in the development of study protocols.
This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Work Environment and Level of Frequency that may be required:
Nearly Continuously: Office environment.
Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing, sitting.
Seldom: Bending, reaching overhead.
Bachelors degree in a health sciences or related field with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.
Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.
This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.