The University of Iowa Hospitals & Clinics, Department of Ophthalmology & Visual Sciences is seeking a 100% Clinical Trial & Data Management Research Assistant (PRV1-3A) to manage and coordinate clinical research activities related to inherited eye diseases, retinal diseases, other eye disorders and conditions. This is a regular fulltime position considered essential for the effective long-term operation of the university. Person appointed to this position will receive the privileges and benefits associated with regular employment status.
Characteristic Duties and Key Areas of Responsibilities :
Assist faculty with clinical trial research activities.
Screen, recruit, enroll and obtain informed consent for clinical trials.
Assist and collect clinical and research data for scheduled trial activities.
Track study participant data, study drugs, biological specimens, and study procedures.
Interact and collaborate with study specific research team members.
Coordinate with ambulatory clinic staff and faculty to complete protocol specific procedure training, certification, participant scheduling, visits, and data retrieval.
Assist and prepare regulatory submissions for new projects, modifications, renewals and close out processes.
Prepare regulatory documents for sponsor approval.
Monitor protocol status processed through the local and central IRB
Interact with local and central IRB for protocol approval.
Prepare and submit internal committee applications for internal institution research services
Maintain regulatory documentation per sponsor, FDA, and GCP guidelines.
Disperse protocol amendments and training investigators and research team members.
Communicate with departmental finance and research administrators progress reports for clinical trial contracts, budgets, and reconciliations.
Maintain and disseminate a list of open protocols and informed consents
Communicate with sponsors, study monitors and clinical research organizations
Assist PI in administering, conducting, and maintaining protocols
Schedule and assist with onsite and/or remote monitor visits. Complete follow up monitor visit reports for assigned trials.
Perform daily activities for clinical trials; respond to clinical site questions for data collection, data entry issues, and queries.
Coordinate and schedule subject visits and trial-related procedures.
Prepare informed consents, brochures, and other materials for study participant visits.
Attend training sessions, as needed, for the implementation of clinical trials.
Assist in data management, validation; query resolution, reporting for quality assurance.
Assist in mentoring new students and research staff.
About the Department of Ophthalmology & Visual Sciences
The University of Iowa Eye Department 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 Hospitals & Clinics-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
Salary: $39,208 - $58,135
Required Qualifications :
Bachelor's degree in related field or an equivalency and/or related experience
6 mths - 1 yr of experience in clinical research
Demonstrate excellent written, verbal, and interpersonal communication skills
Knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor guidelines related to clinical trial research
Demonstrated high attention to detail with strong organizational skills
Proficiency with computers, software, and database systems.
Working with participants and/or patients in a clinical setting
Basic knowledge of EPIC and electronic medical records
Knowledge of University policies, procedures, practices, and regulations
6 mths - 1yr of experience in clinical trial protocol management highly desired
6 mths - 1 yr of experience in data entry and management highly desired
Demonstrated knowledge of or experience with medical terminology highly desired
Basic knowledge of genetics, medical terminology, and disorders highly desired
Application Process: In order to be considered, applicants must upload current CV, desirable cover letter and (3) references (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.
Job openings are posted for a minimum of 14 calendar days. Applications will be accepted until 11:59 PM on date of closing.
Successful candidates will be subject to a criminal background check. This position is not eligible for University sponsorship for employment authorization.