Clinical Research Coordinator Sr.

Job Details

Clinical Research Coord - SR

Job Description

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.

• 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 Bachelor’s degree and 2 years of clinical research experience or Master’s 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

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.