Clinical Research Coordinator Sr

Health Partners Plans; Philadelphia (Philadelphia County); On-site; USD 70,000 - 100,000; Full time

Job summary

Thomas Jefferson University seeks an experienced clinical research professional to oversee day-to-day activities of a clinical trial in line with GCP. Responsibilities include protocol coordination, data management, regulatory submissions, and staff training.

The role requires SOCRA certification or equivalent experience, and strong experience with IRB processes, workflow design, and QA of trial data. US-based on-site work at Jefferson facilities.

Qualifications

• Minimum Qualifications: High School Diploma or GED with 5 years clinical research experience, or 2 years with Bachelor's and 2 years experience, or 1 year with Master's and 1 year experience.
• SoCRA Certification is an additional qualification.
• Regulatory submission experience (IRB) and GCP knowledge are required by protocol.
• Ability to train and orient new staff and develop workflows.

Responsibilities

• Oversee day-to-day activities of a clinical trial per GCP.
• Train and supervise research staff on trial procedures.
• Prepare and submit materials for IRB and regulatory bodies.
• Track expenses and manage documentation for payments.
• Perform quality control of trial data and manage patient data.
• Design electronic capture databases and manage data collected.

Education

High School Diploma/GED with 5 years clinical research experience

Bachelor's degree with 2 years clinical research experience

Master's Degree with 1 year clinical research experience

SoCRA Certification

Job description

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

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 Duties

• 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.

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.

Additional Qualifications

SoCRA Certification

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 hospita