Clinical Research Coordinator

1. compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
2. Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
3. 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.
4. Recognizes, tracks and reports adverse events and protocol deviations.
5. Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
6. Represents the research program at meetings, national and international research consortia.
7. Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
8. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
9. Supervises, mentors and trains new or junior research staff.
10. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
11. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
12. Assists the Principal Investigator in the development of study protocols.

1. Recruits study participants and & obtains informed consent.
2. Contacts participants to schedule study visits and follow-ups.
3. Conducts research assessments, involving administration of structured clinical diagnostic interviews, self-report questionnaires, computer-based cognitive tasks, and psychophysiological measurement.
4. Collects survey data.
5. Reviews medical records.
6. Consults with nurses & physicians to determine pretreatment & eligibility requirements of protocol from completion to registration of participants.

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.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

• A Master’s degree in social work, psychology, counseling, or nursing
• >5 years of clinical trial research experience involving direct patient contact
• Experience working with substance use disorders and/or chronic pain
• Prior research experience collecting and processing physiological data (e.g., heart rate, EEG)