Clinical Research Coordinator Sr. - Melanoma/HEME

About the role

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. Ensures all study procedures are conducted according to the protocol and applicable regulations.

Responsibilities

• 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.
• Ensures all study procedures are conducted according to the protocol and applicable regulations.
• 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 manages all the data collected.
• May provide clerical and technical support to ensure adherence to research protocols and quality of information received.

Requirements

• Minimum High School Diploma or equivalent.
• AND
• 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.

Qualifications

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.

Skills

N/A

Benefits

N/A

Pay

N/A

Schedule

N/A