Jefferson este o organizație din domeniul sănătății și educației care deservește comunități din zona metropolitană Philadelphia, Lehigh Valley, nord-estul statului Pennsylvania și sudul statului New Jersey. Cei peste 65.000 de membri ai echipei sale sprijină furnizarea de servicii medicale în 32 de campusuri spitalicești, precum și activitățile de cercetare și educație profesională desfășurate prin 10 colegii și trei școli, care oferă peste 200 de programe pentru mai mult de 8.300 de studenți. Jefferson oferă, de asemenea, acoperire medicală pentru 360.000 de membri prin Jefferson Health Plans și Health Partners Plans, consolidându-și rolul în sistemul regional de sănătate.
Senior Clinical Research Coordinator – Oncology Trials
Support oncology trial regulatory coordination at Jefferson Health, including PRMC and IRB submissions, regulatory files, amendments, and monitoring preparation.
Descriere
- Oversee clinical trial activities under Good Clinical Research Practice (GCP).
- Manage assigned trial tasks from startup through closeout.
- Coordinate participant screening, recruitment, enrollment, and consent.
- Plan feasibility activities and manage study data.
- Handle biological specimens.
- Prepare for monitoring visits.
- Draft regulatory and IRB documentation.
- Ensure study procedures follow protocols and applicable regulations.
- Support orientation and training for new staff.
- Create workflows and training materials.
- Update standard operating procedures and guidance documents.
- Take part in work groups.
- Act as the primary regulatory contact for assigned protocols.
- Maintain regulatory binders and files, including version control.
- Coordinate submissions to ancillary committees, including Radiation Safety.
- Communicate with IRBs and sponsors about regulatory management.
- Work with study teams and sponsors to finalize documents in response to PRMC and/or IRB recommendations.
- Prepare and submit study amendments and continuing review applications.
- Prepare regulatory files for audits and monitoring visits.
Cerințe
- High school diploma or GED.
- Five years of experience with a high school diploma or GED and SoCRA, or six years of clinical research experience.
- Two years of experience with a bachelor’s degree and two years of clinical research experience.
- One year of experience with a master’s degree and one year of clinical research experience.
- Knowledge of Good Clinical Research Practice (GCP).
- Ability to lift and carry 40–50 pounds.
- Frequent to continuous standing and walking.
- Ability to perform role-specific physical activities, including kneeling, bending, squatting, and CPR where required.
Beneficii
- Medical insurance, including prescription coverage.
- Supplemental insurance.
- Dental insurance.
- Vision insurance.
- Life and accidental death and dismemberment insurance.
- Short- and long-term disability insurance.
- Flexible spending accounts.
- Retirement plans.
- Tuition assistance.
- Voluntary benefits with access to group insurance rates and discounts.
- Tuition discounts at Thomas Jefferson University after one year of full-time service or two years of part-time service.