Top 77 Regulatory coordinator i Jobs in Allentown Pa

Regulatory Coordinator I
St. Luke's University Health Network —Allentown, PA
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Administrative experience
Clinical Research Coordinator I - Precision Medicine (PA/NJ Residents ONLY)
St. Luke's University Health Network —Allentown, PA
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Experience equivalent to degree accepted
Coordinator, Security
GXO Logistics —Bethlehem, PA
- Weekends as needed
- 5 years
- Military
- Pass drug screening
- COVID-19 protective measures
Procurement Coordinator
Gregory Packaging —Bethlehem, PA
- Full-time
- Oracle
- 11+ years
- Research
- Health insurance
- Paid time off
Quick Apply
Coordinator, EHS
GXO Logistics —Bethlehem, PA
- Monday to Friday
- Spanish
- CPR Certification
- Microsoft Excel
- Disability insurance
- Health insurance
7d
Clinical Research Coordinator II- Advanced Research
Lehigh Valley Health Network —Allentown, PA
- Full-time
- Nursing
- Patient monitoring
- RN License
Denials Management Assistant, Part Time
St. Luke's University Health Network —Allentown, PA
- Part-time
- Microsoft Excel
- HIPAA
- Windows
Maintenance Systems Coordinator
Pattern —Bethlehem, PA
- $25 - $38 an hour
- Full-time
- Mid-level
- Continuous improvement
- Warehouse
FACILITIES COORDINATOR
ESFM —Easton, PA
- $70,000 - $80,000 a year
- Weekends as needed
- Background check
- Microsoft Excel
- Microsoft Outlook
- Commuter assistance
- Paid parental leave
Quick Apply
Warehouse Inventory Coordinator
Olympus —Breinigsville, PA
- Overtime
- Microsoft Word
- Mid-level
- High school diploma or GED
- Paid parental leave
- Paid holidays
Environmental Health & Safety Coordinator - Metals Division
East Penn Manufacturing - Deka Batteries —Lyon Station, PA
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Writing skills
- Paid holidays
- Health insurance
Patient Care Coordinator
Jushi —Bethlehem, PA
- Part-time
- Spanish
- Computer literacy
- Research
- Paid holidays
- Disability insurance
Quick Apply
IDD Program Specialist
Onewell Healthcare - Pennsylvania —Allentown, PA
- $20 - $25 an hour
- Full-time
- Clean driving record
- Computer literacy
- HIPAA
- Health savings account
- Paid holidays
Quick Apply
8d
Maintenance / Facilities Coordinator (Part-Time)
OAA Orthopaedic Specialists —Allentown, PA
- Part-time
- Mid-level
- High school diploma or GED
- Ability to lift 50 pounds
- AD&D insurance
- Paid holidays
Quick Apply
Technical Coordinator, Laboratory (Full Time, Days)
St. Luke's University Health Network —Bethlehem, PA
- Weekends as needed
- Mid-level
- Bachelor's degree
- 2 years
CHC Service Coordinator
PA Health Management —Allentown, PA
- $21 - $24 an hour
- Full-time
- Hybrid work
- Experience working with individuals with developmental disabilities
- Spanish
- HIPAA
Quick Apply
Network Coordinator, Coding Audit & Education
St. Luke's University Health Network —Allentown, PA
- Full-time
- 5 years
- Mid-level
- Analysis skills
Scheduling Coordinator
Homewatch CareGivers —Bethlehem, PA
- Full-time
- Background check
- Google Workspace
- Microsoft Excel
- Paid training
- Paid holidays
Quick Apply
Assembly & Material Coordinator
Dexis —Quakertown, PA
- $20.90 - $25.50 an hour
- Computer literacy
- High school diploma or GED
- Assembly
- Paid jury duty
- Paid holidays
1d
Supports Coordinator (Clairton, North Hills, South Hills, and Washington County)
Familylinks —Pennsylvania
- From $20 an hour
- Full-time
- HIPAA
- Mid-level
- Office
- 403(b) matching
- Paid holidays

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Regulatory Coordinator I

St. Luke's University Health Network -
Allentown, PA

Apply Now

Job Details

Full-time

Qualifications

Microsoft Excel
Microsoft Outlook

Full Job Description

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.

Apply Now

Refine Your Search

regulatory coordinator i jobs in allentown pa

Regulatory Coordinator I

Clinical Research Coordinator I - Precision Medicine (PA/NJ Residents ONLY)

Coordinator, Security

Procurement Coordinator

Coordinator, EHS

Clinical Research Coordinator II- Advanced Research

Denials Management Assistant, Part Time

Maintenance Systems Coordinator

FACILITIES COORDINATOR

Warehouse Inventory Coordinator

Environmental Health & Safety Coordinator - Metals Division

Patient Care Coordinator

IDD Program Specialist

Maintenance / Facilities Coordinator (Part-Time)

Technical Coordinator, Laboratory (Full Time, Days)

CHC Service Coordinator

Network Coordinator, Coding Audit & Education

Scheduling Coordinator

Assembly & Material Coordinator

Supports Coordinator (Clairton, North Hills, South Hills, and Washington County)

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

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