Jefferson ir veselības aprūpes un izglītības organizācija, kas apkalpo kopienas Filadelfijas metropoles reģionā, Lehigh Valley, Pensilvānijas ziemeļaustrumos un Ņūdžersijas dienvidos. Vairāk nekā 65 000 tās darbinieku nodrošina aprūpi 32 slimnīcu kompleksos, kā arī veicina pētniecību un profesionālo izglītību 10 koledžās un trīs skolās, kas piedāvā vairāk nekā 200 programmu vairāk nekā 8 300 studentiem. Jefferson arī nodrošina veselības apdrošināšanas segumu 360 000 dalībnieku, izmantojot Jefferson Health Plans un Health Partners Plans, tādējādi paplašinot savu lomu reģiona veselības aprūpes sistēmā.
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.
Apraksts
- 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.
Prasības
- 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.
Priekšrocības
- 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.