QA Assurance Monitor (Hybrid - Clinical Research)

Number of Positions In Requisition

1

Job Details

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.

Job Description

Quality Assurance Monitor

Primary Function: 

The monitor reviews all clinical trials conducted by the Sidney Kimmel Cancer Center (SKCC) at Jefferson.  Extra emphasis is placed on the therapeutic investigator initiated studies being conducted within the SKCC and the SKCC initiated multisite trials.  The monitor ensures protocol compliance and data quality internally and at the clinical research sites via remote and on-site monitoring.

Essential Functions:

·       The monitor is responsible for proactive noncompliance issue identification, escalation, and creation of Corrective and Preventative Actions.

·       Participate in audit preparation, hosting, and post-audit activities to promote the successful outcome of the audit.

·       Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH GCP, etc.) and TJU/SKCC policies.

·       Maintain knowledge of current GCP standards and FDA regulations.

·       Participate in the development or revision of SOPs to support compliance.

·       Conduct clinical research training for new hires, existing staff, clinical investigators, and other Jefferson enterprise staff as needed.

 Other Core Functions and Competencies:

• Assists the Quality Assurance and Process Improvement Unit with administrative responsibilities.
• Interacts with co-workers and other staff consistent with the core values of the University.
• Performs other duties as assigned.

Qualifications: 

Bachelor’s Degree with two years of clinical research experience OR

Master’s degree and one year of clinical research experience  OR

High School with 8 years clinical research experience OR

High School with 6 years clinical research experience with a CRC certification from SoCRA or ACRP.

Experience Requirements:

Minimum of 4 years clinical research experience in clinical research coordination or data management

Preferred: experience in clinical trial monitoring or auditing

Experience with oncology clinical trials and investigator initiated trials is preferred

Familiarity with medical terminology

Skill managing multiple projects with competing deadlines

Skill in written and verbal communication

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

1015 Chestnut Street, Philadelphia, Pennsylvania, United States of America

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health , nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.    

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. 

Benefits

Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem  colleagues, adjunct faculty, and Jeff Temps ), have access to medical (including prescription) insurance.

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