What are the responsibilities and job description for the Clinical Research Coordinator Senior - Endocrinology & Metabolism position at Jefferson Health?
Responsibilities
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.
Essential Functions:
Minimum Education and Experience Requirements:
Education:
Minimum High School Diploma or equivalent.
AND
Experience:
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.
Essential Functions:
- Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
- 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 adher ence to research protocols and quality of information received.
Minimum Education and Experience Requirements:
Education:
Minimum High School Diploma or equivalent.
AND
Experience:
- High School Diploma or equivalent and SoCRA certification preferred 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.
- Must have experience with phlebotomy and drawing blood samples .
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