Job Description

Job Details Incumbent will be responsible for ensuring that clinical trials in the Clinical Trials Office (CTO) are conducted in accordance with Federal, and State governance, institutional regulations, GCP/ICH, and follow all applicable policy. This position will have clinical oversight for all aspects of the clinical research from protocol inception to completion to reporting of all the clinical trials from the disease management teams. All clinical trial requirements including but not limited to all regulatory aspects, clinical coordination, data integrity and management, clinical trial billing and billing compliance, clinical staff (clinical coordination, research nurses) and data management training and competence will fall under the auspices of the Associate Director. The Associate Director will responsible for all non-clinical personnel of the officebut work closely with Nurse Manager of the Outpatient Infusion Center. The Associate Director will work in conjunction with the physician leader of the CTO.

Job Description

ESSENTIAL FUNCTIONS:

• Standard operation procedures, policies, guidelines and work flows for the CTO and ensure they are updated and standardized with other units in the CRO, all Jefferson Health sites, Hospital, University and SKCC. This standardization is also to include the shared drives and all electronic filing.

• Financial and administrative operations of the CTO.

• Manage all efforts efficiently for all clinical research phase trials (I-IV) with in the purview of the SKCC and work closely with the all disease teams and disease team leaders in developing functional disease specific research units with appropriate data management, data coordinator and regulatory support

• Will monitor and improve activation throughput time

• Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.

EDUCATIONAL/TRAINING REQUIREMENTS :

Bachelor’s degree required. Master’s degree preferred

CERTIFICATES, LICENSES, AND REGISTRATION:

RN required

Human subjects training,

EXPERIENCE REQUIREMENTS :

At least 8 years of experience in clinical trials management. Minimum 5 years of experience managing/supervising direct reports

ADDITIONAL INFORMATION :

Knowledge of oncology cooperative groups’ (ECOG-ACRIN,NRG , etc.) regulatory process.

Knowledge of Code of Federal Regulations, good clinical practices (GCPs), and ICH Guidelines for the conduct of clinical trials to include all aspects of clinical and regulatory documentation

Experience with grant writing, report writing required

Excellent computer database skills; excellent scientific/medical writing skills; excellent project management skills, and excellent oral and written communication skills.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

1101 Market, 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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Job Tags

Daily paid, Full time, Temporary work, Part time, Work at office, Flexible hours, Shift work

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