Clinical Research Manager

Job Details

The Clinical Research Coordinator IV trains research staff, supervises staff and oversees clinical trials from start-up to close-out. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents TJU internally and externally, and oversees research operation in department, and provides expert consulting at an institutional level.

Job Description

• Manages all Investigator-lead multi-site trials by developing and implementing processes for document management and IRB submission tracking (i.e. continuing reviews and amendments) for multi-center trials as well as have protocol status knowledge.

• Directs the preparation and submission of regulatory agency applications, reports, and correspondence for opening new studies, protocol amendments, informed consents, continuing reviews, FDA safety reporting, Investigational New Drug applications (INDs), annual reports, Investigational Device Exemption applications (IDEs), etc.

• Provides direct supervision of the research staff which includes conducting on-going training, reviewing workloads, completing annual evaluations, etc.

• Oversees documentation efforts to ensure compliance with domestic and international regulations and standards.

• Identifies issues, recommends changes, writes new standard operating procedures (SOPs) or update existing SOPs with the goal of enhancing regulatory compliance.

Education:

Bachelor’s Degree Required

AND

Experience:

Bachelors Degree and 5 years of clinical research experience or Master’s Degree and 3 year clinical research experience. 2+ years of lead/Project Management experience.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

1015 Walnut 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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