Administrative Services staff provides contractual, budgetary, and educational services for all clinical trials. Administrative Services staff also serve as the primary point of contact for industry collaborators. All of Geisinger’s trials must utilize the CCS Administrative Services. Essential functions include:
- Identifies potential investigators for study opportunities (CCS maintains a database of investigators’ research interests).
- Performs feasibility assessments to ensure that a trial conducted at Geisinger will be successful.
- Executes confidentiality agreements on behalf of investigators.
- Facilitates and monitors research contract negotiations.
- Develops and negotiates study budgets.
Coordinator staff are available to manage all stages of a project’s life cycle, including helping to create workflow strategies, recruiting and retaining subject volunteers, ensuring regulatory compliance, and collecting and archiving data. CCS coordinators have considerable research experience, expertise, and professional certification in a variety of clinical specialties and are situated throughout many of Geisinger’s northeastern and central Pennsylvania hospitals and outpatient clinics. Essential functions include:
- Helps determine study feasibility to ensure high response rates and manage enrollment.
- Custom-tailors 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.
- Contacts, screens and recruits potential study subjects using available resources such as Geisinger’s Electronic Health Record or the services of Geisinger’s Survey Research Unit.
- Serves as the primary liaison between trial subjects and investigators.
- Assumes 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.
- Ensures all data is gathered and recorded. At completion, research staff perform all required study closeout activities, including post-study documentation and data archiving.
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:
- Assist investigators in defining a study’s scope, method, objectives and endpoints.
- Ensures consistency with Geisinger’s mission.
- Assists with protocol writing, editing, and review.
- Determines study feasibility.