What are the responsibilities and job description for the Clinical Trials Research Assistant or Associate - Ophthalmology position at The University of Iowa?
University of Iowa Health Care, Department of Ophthalmology & Visual Sciences, is seeking a full time Clinical Trials Research Assistant (PRV1) or Clinical Trials Research Associate (PRV2). This position is under the supervision of the Clinical Trials Research Specialist.
Primary responsibilities of the Clinical Trials Research Assistant (PRV1; 3A) position include assisting faculty with clinical trial research activities, screening, recruiting, enrolling and obtaining informed consent for clinical trials, collecting clinical and research data for scheduled trial activities, preparing regulatory submissions for new projects, modifications, renewals and close out processes, interacting and collaborating with study specific research team members, and communicating with departmental finance and research administrators progress reports for clinical trial contracts, budgets, and reconciliations.
Primary responsibilities of the Clinical Trials Research Associate (PRV2; 4A) position include performing and overseeing execution, administration and maintenance of study protocols and clinical trial studies, assisting and advising in study design and protocol development/providing input into descriptions of complex research procedures, recruiting potential study participants via known registries and applicable clinics, independently designing, developing, testing and maintaining clinical research trials data systems, managing and monitoring compliance of regulatory guidelines and proper maintenance of documents; preparing regulatory submissions, providing functional oversight of assigned research students, research team members and support staff, demonstrating the ability to maintain clinical trial spreadsheets, recording maintenance to close out trial activities, managing regulatory issue to reflect the sponsor's protocol, and following contractual budget and applying organizational tools for protocol accountability and invoicing.
Full job descriptions for both positions can be obtained by e-mailing Melissa Monhollon at melissa-monhollon@uiowa.edu.
The Department of Ophthalmology and Visual Sciences intends to hire either a Clinical Trials Research Assistant (PRA1) or a Clinical Trials Research Associate (PRA2), based on the qualifications of the successful candidate. Please indicate in your application materials the position you wish to be considered for or indicate both.
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: 3A (PRV1) or 4A (PRV2)
CLINICAL TRIALS RESEARCH ASSISTANT (PRV1) REQUIRED QUALIFICATIONS
- Bachelor’s degree in science, or health science field related to study, or an equivalent combination of education and experience.
- 6 months to one year of experience in clinical research
- Ability to anticipate needs, problems and potential issues and use judgment, foresight and problem-solving skills to troubleshoot, recommend and implement solutions.
- Demonstrate careful attention to detail and accuracy, strong organizational skills and ability to handle multiple tasks quickly and effectively, proactively establish priorities and meet deadlines.
- Excellent written and verbal communication skills required including ability to compose communications and grammatically correct documents in a concise, logical and organized manner.
- Knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor guidelines related to clinical trial research
- Proficient in computer software applications (Microsoft Office Programs).
CLINICAL TRIALS RESEARCH ASSISTANT (PRV1) DESIRED QUALIFICATIONS
- Knowledge of University policies, procedures, practices, and regulations
- Experience processing expense reimbursements/compensation
- Working with participants and/or patients in a clinical setting
- Basic knowledge of EPIC and electronic medical records
- Six months to one year of experience in clinical trial protocol management
- Six months to one year of experience in data entry and management
- Demonstrated knowledge of or experience with medical terminology
- Basic knowledge of genetics, medical terminology, and disorders
CLINICAL TRIALS RESEARCH ASSOCIATE (PRV2) REQUIRED QUALIFICATIONS
- Bachelor’s degree in science, or health science field related to study, or an equivalent combination of education and experience.
- Minimum of five (5) years of progressively responsible experience in a research environment
- Excellent interpersonal, written and verbal communication skills
- Knowledge and experience navigating privacy and confidentiality regulations in human subjects’ research
- Knowledge and experience with conducting clinical trials research, including knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor guidelines related to clinical trial research
- Experience managing Institutional Review Board (IRB) regulatory requirements
- Experience in research data management and database design
- Experience working with participants and/or patients in a clinic setting
CLINICAL TRIALS RESEARCH ASSOCIATE (PRV2) DESIRED QUALIFICATIONS
- Five (5) or more years of progressively responsible experience in the conduct of human subjects’ research
- Active certification as a Certified Clinical Research Coordinator (CCRC) through the ACRP
- Ability to independently design and maintain data collection systems
- Research experience in the fields of ophthalmology and visual sciences
- Experience in research with both minor and adult study participants
- Experience coordinating and scheduling services between multiple departments and/or service providers
- Experience in registry design and implementation
- Experience in research with clinical trials, experimental drug treatments and devices
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
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. This position is not eligible for University sponsorship for employment authorization.
For additional questions, please contact Melissa Monhollon, HR Manager, at melissa-monhollon@uiowa.edu or 319-356-4674.
The Department of Ophthalmology and Visual Sciences intends to hire either a Clinical Trials Research Assistant (PRA1) or a Clinical Trials Research Associate (PRA2), based on the qualifications of the successful candidate. Please indicate in your application materials the position you wish to be considered for or indicate both.
