Regulatory Research Coordinator

Imagine a career at one of the nation's most advanced health networks.

Be part of an exceptional health care experience. Join the inspired, passionate team at Lehigh Valley Health Network, a nationally recognized, forward-thinking organization offering plenty of opportunity to do great work.

LVHN has been ranked among the "Best Hospitals" by U.S. News & World Report for 23 consecutive years. We're a Magnet(tm) Hospital, having been honored five times with the American Nurses Credentialing Center's prestigious distinction for nursing excellence and quality patient outcomes in our Lehigh Valley region. Finally, Lehigh Valley Hospital - Cedar Crest, Lehigh Valley Hospital - Muhlenberg, Lehigh Valley Hospital- Hazleton, and Lehigh Valley Hospital - Pocono each received an 'A' grade on the Hospital Safety Grade from The Leapfrog Group in 2020, the highest grade in patient safety. These recognitions highlight LVHN's commitment to teamwork, compassion, and technology with an unrelenting focus on delivering the best health care possible every day.

Whether you're considering your next career move or your first, you should consider Lehigh Valley Health Network.

Summary
Coordinates activities related to start up, maintenance, and closure of clinical trials within NORI. Participates in the research process by collaborating with the research staff and physician investigators to ensure regulatory compliance related to the administrative aspects of clinical trials. Corresponds with Industry Sponsors, IRB, and NORI administration ensuring regulatory compliance with essential research documents.

Job Duties

• Maintains complete and accurate files of all regulatory documents on each study assigned as per federal regulations.
• Creates and submits documents for review to the IRB for initial opening of a clinical trial, ongoing updates, and annual review submissions.
• Edits and finalizes informed consent documents collaborating with the NORI/IRB office and sponsor of the trial ensuring compliance with local, state, and federal guidelines.
• Disseminates training material to the study teams for each clinical trial to remain in compliance with research policies and tracks the completion of training by each study team member.
• Provides sponsor representatives with regulatory-related information and support during pre-study visits, interim on-site/remote monitoring visits, and closeout visits.

Minimum Qualifications

• High School Diploma/GED
• 4 years of experience in secretarial and/or office management.
• General typing abilities.
• Proficient in Microsoft Word.
• Experience with office equipment such as personal computers, fax machine, copiers, printers, and scanners.

Preferred Qualifications

• 1 year of experience managing the regulatory aspects of a clinical trial or
• 1 year knowledge of medical terminology.
• Knowledge of medical terminology.
• Proficient in other business software applications.

Physical Demands
Lift and carry 25 lbs. frequent sitting/standing, frequent keyboard use, *patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR.

Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.

Lehigh Valley Health Network is an equal opportunity employer. In accordance with, and where applicable, in addition to federal, state and local employment regulations, Lehigh Valley Health Network will provide employment opportunities to all persons without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or other such protected classes as may be defined by law. All personnel actions and programs will adhere to this policy. Personnel actions and programs include, but are not limited to recruitment, selection, hiring, transfers, promotions, terminations, compensation, benefits, educational programs and/or social activities.

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Lehigh Valley Health Network does not accept unsolicited agency resumes. Agencies should not forward resumes to our job aliases, our employees or any other organization location. Lehigh Valley Health Network is not responsible for any agency fees related to unsolicited resumes.

Work Shift:

Day Shift

Address:

2014 City Line Rd

Primary Location:

Bethlehem - 2014 City Line Road

Position Type:

Onsite

Union:

Not Applicable

Work Schedule:

Monday - Friday

Department:

1004-13003 COH-Ntwk Off Rsch And Innov (NORI)