Clinical Research Integrity Coordinator

Temple University Health System

Philadelphia, PA

JOB DETAILS
SKILLS
Auditing, Biotech and Pharmaceutical, Cancer, Clinical Nursing, Clinical Practices/Protocols, Clinical Research, Clinical Training, Clinical Trial, Clinical Trial Management, Disease, Documentation, FDA Requirements, GCP (Good Clinical Practices), Health Education, Healthcare, Hospital, ICH Regulations, Leadership, Maintain Compliance, Medicine, Nursing Credentials, Oncology, Organizational Skills, Patient Charts, Project/Program Coordination, Quality Assurance, Quality Management, Registered Nurse (RN), Requirements Management, Research Nursing
LOCATION
Philadelphia, PA
POSTED
6 days ago

''404090'',''true'',''404090'',''false'',''Submission for the position: Clinical Research Integrity Coordinator - (Job Number: 262721)'',''false'',''404090'',''false'',''true'',''Clinical Research Integrity Coordinator'',''262721'',''!*!The Research Quality Assurance Analyst reviews the requirements necessary for attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level. Promotes adherence to ICH-GCP guidelines by ensuring that data reported is accurate and complete and guarantees that the rights and safety of participants in clinical research are protected. This is accomplished by serving as a resource for the entire Office of Clinical Research (OCR) staff. Assists with pharmaceutical audit preparations and audit responses. Performs eligibility verifications and chart reviews. Research QA Analysts are an integral part of the infrastructure development and help to coordinate projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial education efforts

Education

Bachelor''s Degree Required

Other Graduate of an accredited school of nursing Preferred or

Combination of relevant education and experience may be considered in lieu of degree Required

Experience

1 year experience in a health care environment as a Clinical Research Associate, Clinical Research Coordinator Clinical research Nurse or Medical Chart Auditor Required

2 years experience in clinical trials auditing Preferred

2 years experience in oncology Preferred

Licenses

Cert Clin Research Coordinator Preferred or

Cert Clin Research Associate Preferred

Cert Clin Research Prof Preferred

Assn Clin Res Prof - Cert Prof Preferred

PA Registered Nurse License Preferred

PA Practical Nurse License Preferred

Multi State Compact RN License Preferred Or'',''!*!The Research Quality Assurance Analyst reviews the requirements necessary for attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level. Promotes adherence to ICH-GCP guidelines by ensuring that data reported is accurate and complete and guarantees that the rights and safety of participants in clinical research are protected. This is accomplished by serving as a resource for the entire Office of Clinical Research (OCR) staff. Assists with pharmaceutical audit preparations and audit responses. Performs eligibility verifications and chart reviews. Research QA Analysts are an integral part of the infrastructure development and help to coordinate projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial education efforts

Education

Bachelor''s Degree Required

Other Graduate of an accredited school of nursing Preferred or

Combination of relevant education and experience may be considered in lieu of degree Required

Experience

1 year experience in a health care environment as a Clinical Research Associate, Clinical Research Coordinator Clinical research Nurse or Medical Chart Auditor Required

2 years experience in clinical trials auditing Preferred

2 years experience in oncology Preferred

Licenses

Cert Clin Research Coordinator Preferred or

Cert Clin Research Associate Preferred

Cert Clin Research Prof Preferred

Assn Clin Res Prof - Cert Prof Preferred

PA Registered Nurse License Preferred

PA Practical Nurse License Preferred

Multi State Compact RN License Preferred Or'',''!*!

Your Tomorrow is Here!

Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University.

To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here!

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

'',''!*!

Your Tomorrow is Here!

As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years. Fox Chase Cancer Center, part of the Temple University Health System, is committed to providing the best treatment options for our patients, and delivering that care with compassion.

At Fox Chase, we consider defeating cancer to be our calling. Our unique culture allows employees to work collaboratively with a single, shared focus, regardless of which department they're in.

It's essential for us to recruit not only the best talent in hospital care, but hire well-qualified prospective employees who are committed to serving our patients with the passion and excellence for which Fox Chase is known. Apply today to be part of the future of prevailing over cancer.

'',''Pennsylvania-Philadelphia'',''Pennsylvania-Philadelphia'',''Research & Science'',''Research & Science'',''Full-time'',''Full-time'',''Day Job'',''Day Job'',''Regular'',''Regular'',''false'',''404090'',''404090'',''true'',''404090'',''false'',''Submission for the position: Clinical Research Integrity Coordinator - (Job Number: 262721)'',''false'',''404090'',''false'',''true''

About the Company

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Temple University Health System