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.

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.

Closing Statement

Jefferson includes Thomas Jefferson University and Jefferson Health, a dynamic university and health system with broad reach across the Delaware Valley. Jefferson is the second largest employer in Philadelphia and the largest health system in Philadelphia based on total licensed beds.

Through the merger of Thomas Jefferson University and Philadelphia University in 2017, our University includes ten colleges and four schools. We are an NCAA Division II university and an R2 national doctoral university offering undergraduate and graduate-level programs that provide students with a forward-thinking education in architecture, business, design, engineering, fashion and textiles, health, medicine and social science.

Jefferson Health, the clinical arm of Thomas Jefferson University, has grown from a three-hospital academic health center in 2015, to an 18-hospital health system through mergers and combinations that include hospitals at Abington Health, Aria Health, Kennedy Health, Magee Rehabilitation and Einstein Healthcare Network. We have over 50 outpatient and urgent care centers; ten Magnet®-designated hospitals (recognized by the ANCC for nursing excellence); the NCI-designated Sidney Kimmel Cancer Center (one of only 70 in the country and one of only two in the region); and one of the largest faculty-based telehealth networks in the country. In 2021, Jefferson Health became the sole owner of HealthPartners Plan, a not-for-profit health maintenance organization in Southeastern Pennsylvania. We are the first health system regionally to create an aligned payer-provider partnership.

Jefferson's mission, vision and values create an organization that attracts the best and the brightest students, faculty, staff, and healthcare professionals, as well as the most visionary leaders to drive exceptional results.

• OUR MISSION: We improve lives.
• OUR VISION: Reimagining health, education and discovery to create unparalleled value
• OUR VALUES: Put People First, Be Bold & Think Differently and Do the Right Thing

As an employer, Jefferson maintains a commitment to provide equal access to employment. Jefferson values diversity and encourages applications from women, members of minority groups, LGBTQ individuals, disabled individuals, and veterans.