Clinical Research Coordinator Senior

Number of Positions In Requisition

1



Job Details

Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Runs portions of clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation. Ensuring all study procedures are conducted according to the protocol and applicable regulations. May also assist with the orientation and training of new staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups.

Job Description

Job Summary

The Sidney Kimmel Comprehensive Cancer Center (SKCCC) is seeking a Clinical Research Regulatory Coordinator dedicated to sponsor and investigator-initiated trials. The position reports to a Regulatory Manager within the Research Support Service team of the Clinical Trials Office and provides regulatory support for oncology clinical research studies.

The Regulatory Coordinator is responsible for the accurate compilation and submission of protocols and related study documents to the Protocol Review and Monitoring Committee (PRMC) and applicable Institutional Review Board (IRB), and for maintaining regulatory study files to ensure all protocols and essential regulatory documents are current and complete.

Primary Responsibilities

• Serves as the primary regulatory contact for assigned protocols.
• Maintains the regulatory binders/files and ensures appropriate version control is in place.
• Coordinates submissions to ancillary committees such as Radiation Safety.
• Communicates with the IRB and Sponsor on behalf of the study team regarding regulatory management.
• Collaborates with the study team and sponsors to finalize documents based on PRMC and/or IRB recommendations.
• Prepares and submits study amendments and continuing review applications for PRMC and IRB review.
• Prepares regulatory files for auditing and monitoring visits.

Minimum Qualifications

• High School Diploma/GED
• 5 years High School Diploma/ GED and SoCRA 6 years of clinical research experience or
• 2 years with Bachelor’s degree and 2 years of clinical research experience or
• 1 year with Master’s Degree and 1 year clinical research experience.

Physical Demands
Lift and carry 40-50 lbs. Examples: Push/pull patients on bed, stretcher (requires 29 lbs. push force), lateral transfers up to 50 lbs. of the patient's weight. Frequent to continuous standing/walking. Patient transporters can walk 8-10 miles per shift. *Patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR.

Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

1015 Chestnut Street, Philadelphia, Pennsylvania, United States of America

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.    

Jefferson is committed to providing equal educa­tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. 

Benefits

Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.

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