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Regulatory Coordinator I

St. Luke's University Health Network

Allentown, PA

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JOB DETAILS
SKILLS
Administrative Skills, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Contract Research Organization (CRO), Detail Oriented, Documentation, FDA Requirements, Federal Laws and Regulations, File Maintenance, Financial Disclosure, GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), Healthcare, Healthcare Providers, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Maintain Compliance, Medical Terminology, Microsoft Access Database, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Word, Multitasking, National Institutes of Health (NIH), Network Monitoring, Nursing, Office Management, Organizational Skills, Procedure Development, Regulations, Regulatory Compliance, Safety Process, Secondary School, Time Management
LOCATION
Allentown, PA
POSTED
5 days ago

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.

The Regulatory Coordinator I is responsible is to review, prepare, and submit clinical trial protocols to the IRB ensuring compliance with all local, state, ICH/GCP Guidelines, and federal regulations and to provide administrative support to the regulatory team within the SLUHN Clinical Trials Office.

JOB DUTIES AND RESPONSIBILITIES:

  • Demonstrates basic knowledge and practice of ICH/GP guidelines, FDA regulations and guidelines, HIPPA Regulations and Confidentiality Policy, and IRB policies related to clinical research.
  • Apply knowledge and skills to independently process IND Safety reports via Excel for all industry, Institutional, and NCTN (cooperative group) studies in an expeditious manner.
  • Track IRB submissions, approvals and expiration dates for all protocols, including initial, annual and amendment submissions to ensure timely turnaround times.
  • Ensure that submissions are accurate, properly formatted, complete, and in compliance with regulations and IRB policies and procedures.
  • Collaborates with the Regulatory team and other clinical trials staff to develop and maintain procedures for management of all regulatory aspects of the clinical trials.
  • Acquire the appropriate signatures for regulatory forms, and develop tracking tools for this process.
  • Prepare, maintain, and file all essential regulatory documentation required by sponsor or CRO (1572s, Financial Disclosure Forms, Delegation Logs, CVs and Medical Licenses, FCOI forms, SAEs and UAPs, training logs, etc.) within the study and regulatory binders.
  • Collect, maintain, and file all institutional clinical trials training requirements and tracking logs (NIH COI tutorial, CITI GCP, SLUHN COI disclosure statement, CVs, and Medical Licenses)
  • Collect, maintain, and file all institutional laboratory documents and tracking logs for Network (Lab Normal Reference Ranges, CAP, CLIA, Lab Permits, and Lab Director CV and Medical License)
  • Maintain NCI Investigator registration on a yearly basis as required by the NCI for NCTN studies.

PHYSICAL AND SENSORY REQUIREMENTS:

Requires sitting for up to seven hours per day, 5 hours at a time. Standing for up to 4 hour per day, 3 hours at a time. Requires frequent fingering, handling and twisting and turning. Frequently requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds. Frequently requires reaching above shoulder level and bending down. Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision.

EDUCATION:

Associate degree required; will accept High School degree with 1-2 years regulatory or administrative assistant/office management experience. Familiar with medical terminology preferred.

TRAINING AND EXPERIENCE:

Required: Knowledge of Microsoft Office Programs: Word, Excel, Access, Outlook; Internet Functions. Must possess strong organizational skills and strong attention to detail. Must be able to multi-task efficiently.

Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!!

St. Luke's University Health Network is an Equal Opportunity Employer.

About the Company

S

St. Luke's University Health Network

St. Luke's University Health Network is a regional network of hospitals, physicians and other related organizations providing care primarily in Lehigh, Northampton, Monroe, Carbon, Schuylkill, Bucks, Montgomery and Berks counties in Pennsylvania and Warren County in New Jersey.

The Network provides services at more than 150 sites. St. Luke's University Health Network is comprised of six hospital sites. The Network includes:

  • More than 80 owned physician-practice sites
  • 300 employed primary care/specialist physicians
  • Various outpatient testing and service facilities
  • Home health
  • Hospice services (inpatient and outpatient)
  • Largest ambulance provider in Bucks County and second largest in Lehigh County
  • Other related organizations
  • 57,500+ annual admissions
  • 195,000 annual emergency room visits
  • 1,325 physicians on the Medical Staff (96 percent board-certified)
  • 8,600+ employees
  • More than 1,350 volunteers

Areas of exceptional medical expertise include:

  • Level 1 Adult Trauma Center: fully accredited by Pennsylvania Trauma Systems Foundation; 2,400+ annual trauma cases; St. Luke's 1.75 percent mortality rate represents top decile performance, significantly better than peer group as measured by National Trauma Data Bank of the American College of Surgeons; aeromedical transport services
  • Oncology: first and only cancer program in Pennsylvania to receive American College of Surgeons' highest quality recognition for three consecutive years; only Pennsylvania program to receive award in 2010; region's only fellowship-trained surgical oncologists; advanced programs for melanoma (internationally recognized melanoma investigator), lung, breast, prostate, gynecologic and gastrointestinal cancers and tumors of the brain and spine
  • Cardiology and Cardiovascular Surgery: multiple-year recipient of highest rating for cardiac bypass surgery, represents top decile performance achieved by only 10 percent of U.S. hospitals (Society for Thoracic Surgery); region's first Joint Commission certified Heart Failure Program; comprehensive surgical services excluding heart transplants
  • Neuroscience: accredited Stroke Center; additional Centers of Excellence include: Balance Center, Headache Center, Memory Disorders Center, Multiple Sclerosis Center, Sleep Disorders Center
  • Orthopaedics: advanced expertise in total joint replacement and reconstruction, computer-assisted minimally invasive surgery, primary and reconstructive surgery of the spine, sports injuries, diseases and conditions of the hand and elbow, traumatic injuries
  • Women's/Children's Health: high-risk pregnancy; the region’s busiest obstetrical service; two neonatal intensive care units; pediatric specialty care provided by St. Christopher's Hospital for Children.
  • Robotic/Minimally Invasive Surgery: one of the nation's most experienced robotic surgical teams
  • Radiology: designated international General Electric Healthcare Show Site for imaging technology; designated Breast Imaging Center of Excellence by American College of Radiology
  • Bariatric Surgery: designated Center of Excellence by American Society for Metabolic and Bariatric Surgery and Surgical Review Corporation

St. Luke's offers an exceptional benefit plan for employees. Our values are reflected in all we do for patients, each other and the community:

Pride - We take pride in our accomplishments and in our organization.

Caring - We show consideration for others and their feelings. We treat others as we want to be treated.

Respect - We recognize the value, diversity and importance of each other, those we serve and the organization.

Accountability - We are responsible to make decisions and solve problems in a timely and effective manner.

Flexibility - We adapt to the changing needs and expectations of those we serve.

Teamwork - We work together to improve quality.

The mission of St. Luke's University Health Network is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.

COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Healthcare Services