Clin Trials Research Associate Job Opening
Clin Trials Research Associate
The University of Iowa• Iowa City, Iowa
Category: Enrollment Counselor
Classification Title: Clinical Trial & Data Management Research Associate/Data Manager
Department: Pediatrics, Division of Medical Genetics & Genomics
Pay Grade: https://hr.uiowa.edu/pay/plans
Percent of Time: 100%
Schedule: Monday-Friday between 8am-5pm.
Location: General Hospital
Staff Type: Professional & Scientific
Type of Position: Specified Term
Drivers License required: No
About the Stead Family Department of Pediatrics and UI Stead Family Children’s Hospital
The Stead Family Department of Pediatrics is a national leader in pediatric medicine. The Department’s mission is to provide outstanding care to the children of Iowa and beyond by being a leader in state-of-the-art clinical care to children, performing cutting-edge research to find new treatment and cures for childhood illnesses, and educating the next generation of pediatric health care providers. The Department comprises the medical and research staff of UI Stead Family Children’s Hospital. UI Stead Family Children’s Hospital is one of the nation’s top-ranked pediatric care and research institutions and Iowa’s only comprehensive children’s hospital.
About the Division of Medical Genetics & Genomics
The Division of Medical Genetics & Genomics is committed to excellence in providing comprehensive services for children, adults and prenatal patients in the diagnosis, treatment, and management of genetic conditions. The Division's multidisciplinary team is comprised of board certified medical geneticists, a molecular genetic pathologist, physician assistants, nurse practitioners, genetic counselors, nurses, and dietitians. Our clinics include: General Genetics Clinics, Metabolic Genetics Clinics, Neurofibromatosis Clinics and Outreach Genetics Clinics. Genetic diseases and disorders affect families as well as individuals. The medical team provides the information, support and follow-up needed to make informed decisions. Our medical genetics team collaborates with state and federal agencies, educators, researchers, support groups and others to provide the latest information and treatment options for Iowans and their families.
Position Summary: Within the Stead Family Department of Pediatrics-Division of Medical Genetics & Genomics coordinates, negotiates, executes, and manages clinical research studies as they relate to lysosomal disorders and other medical genetic disorders; coordinate the processing and analysis of research data; submit clinical research study protocols and procedures; ensure compliance of clinical research requirements; recruit patients for studies.
Protocol Development/Management and Study Responsibilities
- Consult with researchers to assist in developing a data management plan; design forms to facilitate the collection and tracking of study participant data, study drugs, biological specimens, and study procedures.
- Design and coordinate field tests for data collection forms and assisting in design of certification procedures.
- Maintain and disseminate a list of open protocols and informed consents.
- Prepare regulatory documents for sponsor approval.
- Prepare IRB documents for protocol approval.
- Research, change, and submit protocol amendments for IRB approval.
- Submit protocol data, yearly renewals, and study modifications to the IRB in a timely fashion.
- Monitor protocol status as it is process through the IRB.
- Submit applications to the CRU for clinical studies that will utilize their services.
- Review query reports. Resolve all monitoring visit issues. Perform and monitor randomizations.
- Communicate to sponsors.
- Manage and maintain protocols.
- Monitor visit reports for all studies.
- Responsible for site management and daily activities associated with a clinical trial; respond to clinical site monitoring questions regarding data collection and data entry issues.
Research/Clinical Activities; Subject Recruitment and Enrollment
- Assist with clinical data coordination for research activities.
- Inform PI of changes, proposed changes, new content being discussed, and/or problems and inconsistencies in the study protocols.
- Establish participant eligibility on the various protocols.
- Oversee the scheduling of trial-related procedures.
Data Collection and Monitoring
- Assist in managing data validation, query resolutions, and the reporting of data; conduct audit to assess quality assurance.
- Perform all data processing tasks; enter data, verify data, identify problem data, generate queries, etc.
- Coordinate the processing of data from various sites/centers/studies.
- Coordinate with Clinical Research Unit and ICTS.
- Work with Pathology to coordinate lab activity that is done in the research subject’s community and ship lab specimens when needed.
- Validate data, query resolution, and make recommendations for resolution. Revise and implement change in data collection.
- Update and maintain the requirement and specifications for the electronic data capture systems.
Regulatory Guidelines and Documents
- Assist in conducting audits to assess quality assurance.
- Develop procedures for on-site data audits; participate in audits; design and generate reports for use in data audits; summarize results of audits and write reports.
- Prepare for the program on-site audit.
- Audit participant informed consent documents.
- Manage and organize regulatory documentation from sites and regulatory authorities.
- Prepare regulatory submissions.
- Perform on-site audits of research and clinical data.
- Monitor compliance of regulatory guidelines and proper maintenance of documents.
- Serve as administration liaison with regulatory offices. Communicate with IRB Chairs, HSO staff, and UI investigators to improve IRB application and review process.
- Complete regulatory submission and close out process.
- Assume responsibility of reportable events reporting.
- Assure compliance of studies with all regulatory requirements.
- Mentor new staff under direction.
- Attend training sessions as needed for the implementation of clinical trials.
- Serve as the liaison to the Patient Fiscal and Registration Services to identify exact patient tests and procedures to be paid by the study sponsors and to assist with questions related to billing for protocol treatment procedures.
- Develop and manage budgets.
- Maintain records on services provided and work within individual protocol budgets.
- Determine budget for functional unit and/or multiple complex studies; approve expenditures.
Please attach a resume & cover letter as part of the application process. Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. For questions or additional information, please contact [email protected]
Successful candidates will be subject to a criminal and credential background check.
- A Bachelor’s degree in health sciences or statistics or an equivalent combination of education and experience.
- One to three years of work experience in clinical trial protocol management.
- Demonstrated excellent written, verbal and interpersonal communication skills.
- Demonstrated high attention to detail with strong organizational skills.
- Knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor guidelines related to clinical trial research
Highly Desirable Qualifications
- Demonstrated knowledge of or experience with medical genetic and lysosomal storage disorders
- Experience with statistical analysis using SAS, R, and Microsoft Access
- CCRC (Certified Clinical Research Coordinator) or CCRP (Certified Clinical Research Professional) certification, OR a master’s degree in a related field (e.g. MPH)
- One to three years of experience in data entry and management
- Knowledge of University policies, procedures and regulations
- Experience processing expense reimbursements (e.g. travel, meals)
- Willingness and ability to travel