University of Iowa Health Care, Department of Ophthalmology & Visual Sciences, is seeking a full time Clinical Trials Research Specialist (PRV3; 5A). The Clinical Trials Research Specialist (PRV3; 3A) oversees all aspects of the Department of Ophthalmology & Visual Sciences’ clinical trials and supervises a team of employees supporting clinical research. Together, the specialist and team provide end-to-end support for variety of ophthalmological clinical trials sponsored by industry, the NIH, and private foundations, as well as for investigator-initiated studies. The Clinical Trials Specialist oversees the guidance of faculty and learners for IRB processes and other issues related to human subject research. Lastly, the Clinical Trials Research Specialist is responsible for overall quality assurance of the work of this group with an emphasis on timeliness, patient confidentiality, data security, and ensuring that the work product is robust to internal and external audits. The Clinical Trials Research Specialist also works closely with and is supervised by, the Grants and Contracts Manager for the department. Position responsibilities include:
- Supervise clinical trials staff: delegate work, train and provide guidance on IRB, protocol development, subject recruitment, implementation, monitoring visits; provide opportunities for career development.
- Establish and implement a triage system for IRB approval requests in the department.
- Together with the clinical trials research team members, help investigators to understand human subjects and other regulatory processes.
- Answer and triage queries related to potential new trials to faculty and staff; work with team to fill out feasibility questionnaires.
- Oversee the creation of informed consent documents, IRB submissions, and IRB revisions.
- Assist with and advise on protocol development to ensure compliance with University of Iowa rules and regulations.
- Evaluate data and records for accuracy and completeness.
- Evaluate and analyze data collection procedures. Update and maintain requirements and specifications for the electronic data capture systems.
- Together with the clinical trials research team members, create and maintain inspectional binders for appropriate clinical trials. Create SOPs as appropriate for the binders.
- Assemble and submit adverse event reports to appropriate authorities including FDA and/or sponsor. Draft corrective action plans as necessary.
- Act as liaison between Department and IRB.
- Organize or delegate the organization of patient visits for studies from other UIHC departments to Ophthalmology Clinic.
- Verify all prerequisites have been completed and are within the required parameters for subjects on protocol.
- Verify clinic/study procedures, follow study participants, and manage collection of accurate data in a timely manner, keeping data and documentation secure and confidential
- Assist in obtaining patient consent to protocols when needed.
- Oversee the maintenance of records of services provided.
- Prepare educational materials for subjects and staff as needed to carry out protocols
- Attend coordinated protocol meetings as required.
- Performs other projects or tasks as assigned.
The University of Iowa Health Care Department of Ophthalmology & Visual Sciences has a long history of providing outstanding care for our patients, conducting leading-edge collaborative research, and educating the next generation of ophthalmologists and vision science researchers. We have consistently been ranked nationally in the top ten of Ophthalmology Departments by U.S. News and World Report since 1994. We are actively engaged in clinical trials and research studies involving vision and eye diseases. Our physicians and researchers collaborate with colleagues on many investigator-led, industry-sponsored, or government-supported trials that seek to improve vision for our patients and beyond.
University of Iowa Health Care—recognized as one of the best hospitals in the United States—is Iowa’s only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives.®
Percent of Time: 100%
Schedule: Monday – Friday, 8:00a-5:00p
Location: UIHC, Iowa City
Rotations: N/A
On Campus: This position is performed fully on campus.
Pay Level: 5A
REQUIRED QUALIFICATIONS
- Bachelor’s degree or equivalent combination of education and experience.
- Five (5) or more years of progressively responsible experience in health science research or an equivalent combination of education and experience.
- 1-3 years of supervisory experience.
- Demonstrated success in motivating a team to work together to achieve a high level of efficiency and group cohesion.
- Demonstrated ability to manage multiple concurrent deadlines.
- Excellent written and verbal communication skills.
- Expertise in Microsoft Office including word, excel, etc.
- Experience with electronic data capture systems.
- Experience working with human subjects research in an academic research environment.
DESIRED QUALIFICATIONS
- Master’s degree in a related field
- Certification in clinical trials research by ACRP or SOCRA.
- Experience with VA IRB or IRB-03
- Familiarity with ophthalmology.
- Knowledge of university policies and procedures.
POSITION & APPLICATION DETAILS
In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:
- Resume
- Cover Letter
