Jefferson
Clinical Research Coord Senior - Integrated Medicine
Jefferson, Villanova, Pennsylvania, United States, 19085
Clinical Trial Coordinator
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, track 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. 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. Work Shift: Workday Day (United States of America) Worker Sub Type: Regular Primary Location Address: 789 East Lancaster Avenue, Villanova, Pennsylvania, United States of America Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. At Jefferson, we offer a comprehensive total rewards package designed to support the health and well-being of our colleagues and their families. It includes a wide range of benefits including competitive pay, health and retirement benefits, life and disability insurance, paid time off, educational benefits, financial and mental health resources and much more. Our diverse benefits offerings ensure you have the coverage and access to services you need to thrive both personally and professionally.
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, track 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. 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. Work Shift: Workday Day (United States of America) Worker Sub Type: Regular Primary Location Address: 789 East Lancaster Avenue, Villanova, Pennsylvania, United States of America Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. At Jefferson, we offer a comprehensive total rewards package designed to support the health and well-being of our colleagues and their families. It includes a wide range of benefits including competitive pay, health and retirement benefits, life and disability insurance, paid time off, educational benefits, financial and mental health resources and much more. Our diverse benefits offerings ensure you have the coverage and access to services you need to thrive both personally and professionally.