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

• Oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP).

• Trains and supervises research staff on the proper procedures for conducting a clinical trial per GCP.

• Prepares and submits all materials for the Institutional Review Board (IRB) and other regulatory bodies as required by the protocol to ensure compliance in a timely fashion.

• Maintains accurate subject log, tracks expenses, submits appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies.

• Performs regular quality control assessments to ensure that clinical trial data is collected and stored per GCP.

• Organizes and maintains documentation of all patient data.

• Designs electronic capture databases, if appropriate, and manage all the data collected.

• May provide clerical and technical support to ensure adherence to research protocols and quality of information received.

Education:

Minimum High School Diploma or equivalent.

AND

Experience:

High School Diploma or equivalent and SoCRA certification and 6 years of clinical research experience or Bachelors degree and 2 years of clinical research experience or Masters Degree and 1 year clinical research experience.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

800-803 Walnut Street, Philadelphia, Pennsylvania, United States of America

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 diemcolleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.

For more benefits information, please click