The Department of Epidemiology in the College of Public Health is seeking a Clinical/HC Research Associate to participate in the execution and administration of clinical research trials; coordinate the processing and analysis of data; coordinate clinical trial protocols and procedures; develop new and/or revised research methodologies for MOST (Multicenter Osteoarthritis Study).

Protocol Development/Management and Study Responsibilities

• Coordinate, manage and maintain all MOST (Multicenter Osteoarthritis Study) protocols. Establish study-related metrics for efficiency and success.
• Prepare site reports, including feasibility questionnaires, progress and status reports and recruitment proposals; review and evaluate accuracy of monitor site visit reports for all studies.
• Communicate with health care practitioners, agencies, and sponsors and their clinical research organization (CRO) representatives.
• Arrange and coordinate hospital services that are required by protocols; coordinate billing arrangements for the services.
• Responsible for site management and daily activities associated with a clinical trial; respond to clinical site questions regarding data collection and data entry issues. Work with study monitors to assure timely and complete data entry and resolution of queries.
• Oversee and provide staff training and guidance for administrative and study coordinator duties.
• Organize and facilitate pre-study site feasibility visits, site initiation visits, monitor and other audit site visits and monthly staff meetings.
• Maintain current knowledge of methods and trends relevant to MOST through library research and by attending continuing education seminars and presentations.
• Attend multicenter Investigator’s Meetings and training sessions.

Research / Clinical Activities; Subject Recruitment and Enrollment

• Oversee operations of clinical research studies including the recruitment, coordination and scheduling of subject participation and procedures per protocol requirements.
• Develop recruitment materials and strategies for all MOST clinical trials. Oversee and coordinate recruitment efforts, including advertising, media releases, institution-wide mass email distribution, database searches, medical chart and electronic medical record review, and direct mailing.
• Administer and review screening interview questionnaires, lab data and medical history of potential research participants according to protocol inclusion and exclusion criteria for each study to determine their study eligibility.
• Present study description to prospective participants, including a discussion of risks and requirements.
• Screen and enroll participants, ensuring that all prerequisites have been completed and are within the required parameters.
• Perform study procedures as outlined in the study protocol, including obtaining informed consent, eliciting medical and health history and determining eligibility.
• Perform study assessments dictated by protocol to include vital signs, body measurements, and other required study procedures. Prepare and process lab specimens for shipping.
• Dispense study drug with instructions, monitor compliance to study medication and protocol and perform medication and adherence counseling to achieve high compliance standards.
• Organize clinic/study procedures, follow study participants and manage collection of accurate data in a timely manner, keeping data and documentation secure and confidential.
• Develop, implement and consult with staff regarding compliance strategies, aids and educational materials for participants and their families as support groups.
• Interview participants to monitor and document adverse medical events at follow-up visits and phone calls. Notify the sponsor within 24 hours and submit documentation, including medical records, regarding any serious medical event to sponsor, according to protocol requirements, and to IRB, if appropriate.
• Monitor and counsel participants regarding appropriate study diet and lifestyle recommendations. Review dietary, blood glucose and study medication diaries with participants and counsel for compliance.
• Assist with inventory, documentation, secure maintenance and return of all study drugs.
• Recognize and refer abnormal findings and situations that require immediate attention of the physician.
• Review new protocols and work with PI to determine study coordinator assignments.

Data Collection and Monitoring

• Evaluate and analyze data collection procedures.
• Update and maintain the requirement and specifications for the electronic data capture systems.
• Organize database search and analysis procedures.

Regulatory Guidelines and Documents

• Manage and organize site regulatory documentation from regulatory authorities. Prepare and submit regulatory documents for review and approval of new studies, modifications, continuing reviews, protocol deviations, IND/safety reports and study closure.
• Perform on-site audits of research and clinical data in preparation for sponsor/regulatory audits and monitor site visits.
• Communicate with IRB staff and investigators.
• Monitor compliance of regulatory guidelines and proper maintenance of documents.
• Consult with Center Director regarding safety of subjects.
• Assume responsibility for reportable events reporting, and any corrective actions taken.

Human Resources / Leadership

• Hire, develop and manage the performance of administrative, research, and support staff, including conducting annual performance reviews and monitoring assignments, progress and performance goals.
• Monitor and approve vacation/sick leave of all supervised staff to ensure adequate clinic coverage at all times or as required.
• Assure staff is compliant with UI policies and procedures.

Financial Responsibility

• Negotiate budgets for industry-sponsored clinical trials.
• Develop internal budgets for all MOST projects.
• Oversee clinical budget and monitor monthly clinical performance reports.
• Submit and track contracts for all MOST projects, including Confidential Disclosure and Clinical Trial Agreements, to assure timely completion and prevent costly delays in study startup that could affect site’s ability to meet enrollment goals.
• Develop budgets for recruitment and adherence activities.

Position and Application Details:

This position is located at the Towncrest Clinic on the eastside of Iowa City.

To be considered for an interview, applicants must upload a resume and cover letter and mark them as a “Relevant File” to the submission.

Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.

For questions, contact Michele Hogue at michele-hogue@uiowa.edu.

Benefits Highlights:

Regular salaried position. Located in Iowa City, Iowa. Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.

Requires:

Requires the academic knowledge of a discipline that is generally associated with a Master’s degree or an equivalent combination of education and progressively responsible experience in the conduct of clinical research, specifically in the administration of trials, including regulatory and budget preparation.

Previous research protocol management experience including single and multicenter studies.

Previous experience with ONI Orthone MRI, X-Ray, musculoskeletal equipment

Previous clinical experience in osteoarthritis.

Considerable (3-5 years) experience with and participation in clinical trials.

Knowledge of regulatory guidelines and procedures.

Strong communication and organizational skills and ability to work with community and health professionals and the public.

Experience with personal computer systems and proficiency using spreadsheet (MS Excel), word processing (MS Word) and database (MS Access) software.

Experience in preparing and submitting IRB application materials and Informed Consent Documents

Valid US driving license and ability to meet the University of Iowa Fleet Safety Program driving standard is required.

Desires:

Some knowledge of University practices, rules and regulations.

Phlebotomy or venipuncture knowledge or experience desirable.

Fluency in speaking, reading, writing, and understanding the English and Spanish languages.

The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, gender identity, or associational preferences.