Clin Trials Rsrch Specialist - ICTS Coordinator Core

University of Iowa • Iowa City, IA

3d • Hybrid

About The Position

We are seeking a Clinical Trial & Data Management Research Specialist in the Institute for Clinical and Translational Science will be an integral member of the research team in the Institute for Clinical and Translational Science. This position will provide support for the ICTS by performing activities which are vitally important to ICTS mission, as well as to grow and foster innovation through research support endeavors. The clinical trial research specialist/ data manager will apply clinical skills to administer, deliver, and evaluate research protocols.

Requirements

• A Master’s degree in a related field or an equivalent combination of education and experience is required.
• A minimum of five years of related research protocol management experience including study start-up, data collection, entering, tracking, maintaining data, and troubleshooting study conduction.
• Experience designing, developing, and implementing recruitment program materials.
• Working knowledge of Good Clinical Practice (GCP) in research.
• Excellent written and verbal communication skills.
• Experience developing and working with research budgets/billing.
• Ability to work nights and weekends.
• Must be proficient in computer software applications (MS Word, Excel, PowerPoint, and Outlook).

Nice To Haves

• Certification in Clinical Research Conduction
• Experience with REDCap, Epic and ACCESS.
• Experience using EPIC subject identification and recruitment.
• Previous experience in data collection and entry.
• Experience in processing research regulatory documents and budget preparation.
• Excellent time management skills and ability to perform detail-oriented work.

Responsibilities

• Function as the specialist/technical expert in a specific skilled/specialized area.
• Coordinate the care of research participants according to protocols requiring a high level of judgment and independent action.
• Coordinate the screening of patients for study eligibility and consent for clinical trials.
• Educate patient/participant on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient/participant.
• Develop and coordinate the delivery of information to principal investigators and verify participant eligibility.
• Administer study treatments and identify adverse reactions.
• Review new protocols and assign to appropriate staff.
• Screen, recruit, enroll and obtain informed consent for clinical research activities. Oversee the recruitment of participants and scheduling of trial-related procedures.
• Develop new recruitment plans and methods for new studies, provide ongoing assessment to determine if plan is successful.
• Develop complex study recruitment materials for new and ongoing studies.
• Develop, edit, coordinate, manage, and maintain protocols.
• Collaborate with Principal Investigator and the study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
• Assess participants for problems related to protocol, communicate with the Principal Investigator to maintain proper protocol conduction by the study team.
• Oversee CRF development, database development and maintenance.
• Review query reports. Resolve all monitoring visit issues.
• Perform and monitor randomizations.
• Develop complex study materials used in conduction of study.
• Communicate with local health care practitioners, agencies, and sponsors as needed.
• Oversee the design; development and testing of clinical research trial data systems for new studies.
• Maintain communication between health care clinical information systems and research data systems.
• Collect and validate data. Make recommendations for query resolution.
• Assist with identification of data problems and implement change as needed.
• Manage and organize regulatory documentation.
• Prepare and submit regulatory documents.
• Assist sponsor with on-site audits of research and clinical data.
• Monitor and maintain compliance of regulatory guidelines and documents.
• Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
• Develop and carry out corrective action plan for reportable events.
• Develop and administer study budgets.
• Participate in preparation of grant applications for extramural funding.
• Assist with tracking and reconciling grant budget free balances.
• Identify opportunities to ensure that grant funding is being used as intended and awarded.
• May assist with hiring and provide management of the day-to-day performance of staff; assure staff are compliant with UI policies and procedures.
• Identify education/training needs and develop required training programs to meet study needs.
• Educate and mentor staff at all stages of development and growth.

Benefits

• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level