Thanks for considering a career with Fort Wayne Neurological Center! We are always looking for talented people who are passionate about making a difference. If you are interested in exploring opportunities, please contact us at: email@example.com
Clinical Research Manager
We are seeking a dynamic and creative Research Manager with experience in the conduct of clinical research from study startup and budget negotiations, to interfacing with sponsors and IRBs, to the completion of the query process. The ideal candidate will be a hands-on, innovative leader who has the passion and business acumen needed to continue to grow and differentiate Fort Wayne Neurological Research Center.
- Staff Management and Development – Participate in the orientation, training and supervision of CRCs; participate in facilitating departmental trainings; align staff and resources with appropriate protocols and research needs; and maintain workflow consistency among staff with standardized processes.
- Operation Management -Champions operation excellence by engaging in continuous improvement of processes, sharing best practices and participating in efforts to improve research within the program. Oversee contract, budget negotiations, and expense monitoring (P/L). Ensure enrollment goals of the study are being met. Assist with study start up including regulatory management, source creation, training and workflow.
- Quality Assurance – Perform regular audits to ensure that the data collected is complete and accurate, and that the research trial is carried out as planned. Support the team and investigators in overall conduct of the trials
- Regulatory Compliance – Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Ensure that research protocols are approved by the Institutional Review Board/Privacy Board (IRB/PB) and followed as written. Update, revise and keep current site SOP’s.
- Data reporting – Generate reports to all necessary parties. Prepare data for analysis, monitoring visits and audits
- Bachelor’s degree with at least 3 years of clinical research experience OR a high school diploma with 6 years of clinical research experience.
- Supervisory experience and experience with high volume trials is required.
- Strong time management/project management skills.
- Knowledge of neurology-specific terminology is preferred.
- Ability to act independently to establish logical priorities, to identify improvement opportunities and to develop action plans.
- Experience in the use of various electronic data management systems. Strong Data management skills preferred.
- Excellent communication, interpersonal and organization skills