The Cardiovascular Center for Clinical Research (CCCR) staff offers administrative and coordinator services for investigator-initiated trial Sservices.
Investigator-initiated trial services staff collaborates with investigators who wish to develop a research project with or without the financial support of a sponsor. Working closely with the Geisinger Biostatistics and Research Data Core, our staff offers principal investigators individual assistance in study protocol development and implementation. Essential functions include:
- Assisting investigators in defining a study's scope, method, objectives and endpoints
- Ensuring consistency with Geisinger's mission
- Assisting with protocol writing, editing, and review
For more information about any of the CCCR services, contact us.
Administrative services staff provides contractual, budgetary, and educational services for clinical trials at Geisinger's Heart and Vascular Institute. Administrative services staff also serves as the primary point of contact for industry collaborators. Essential functions include:
- Identifying potential sub-investigators for study opportunities
- Performing feasibility assessments to ensure that a trial conducted at Geisinger will be successful
- Facilitating and monitoring research contract negotiations
- Developing and negotiating study budgets
Coordinator staff is available to manage all stages of a research project's life cycle, including helping to create workflow strategies, recruiting and retaining subjects, ensuring regulatory compliance, and collecting and archiving data. The CCCR coordinators have considerable research experience, and expertise, and are situated throughout several of Geisinger's northeastern and central Pennsylvania hospitals and outpatient clinics. Essential functions include:
- Helping determine study feasibility to ensure high response rates and manage enrollment
- Creatings a study plan to address all aspects of study implementation with each stage of the trial carefully evaluated, and if necessary, adjusted for optimal results
- Recruiting potential study subjects using available resources such as Geisinger's Electronic Health Record or the services of Geisinger's Survey Research Unit
- Serveing as the primary liaison between trial subjects and investigators
- Assuming responsibility for regulatory submissions, ensuring that trials comply with all regulatory and institutional guidelines. Geisinger has a long-standing commitment to rigorous and uncompromising standards of safety and protection of research subjects
- Ensuring all data is gathered and recorded. At completion, research staff performs all required study closeout activities, including post-study documentation and data archiving.