Clinical Research Coord Sr. - KCC
About The Position
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.
Requirements
- High School Diploma or equivalent and SoCRA certification and 6 years of clinical research experience
- Bachelor’s degree and 2 years of clinical research experience
- Master’s Degree and 1 year clinical research experience
Responsibilities
- Oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP).
- Run 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.
- Ensure all study procedures are conducted according to the protocol and applicable regulations.
- Assist with the orientation and training of new staff.
- Assist in the development of workflows, training documents, SOP/guidance document revision.
- Participate in work groups.
- Train and supervise research staff on the proper procedures for conducting a clinical trial per GCP.
- Prepare and submit all materials for the Institutional Review Board (IRB) and other regulatory bodies as required by the protocol to ensure compliance in a timely fashion.
- Maintain accurate subject log, track expenses, and submit appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies.
- Perform regular quality control assessments to ensure that clinical trial data is collected and stored per GCP.
- Organize and maintain documentation of all patient data.
- Design electronic capture databases, if appropriate, and manage all the data collected.
- Provide clerical and technical support to ensure adherence to research protocols and quality of information received.
Benefits
- Medical (including prescription)
- Supplemental insurance
- Dental
- Vision
- Life and AD&D insurance
- Short- and long-term disability
- Flexible spending accounts
- Retirement plans
- Tuition assistance
- Voluntary benefits
- Tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service
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What This Job Offers
Job Type
Full-time
Career Level
Senior
