Regulatory Specialist (40 hours/week)
HOURS: Full-time, 40 hours a week or 1.0 FTE. No Weekends or Holidays.
POSITION SUMMARY: To organize, coordinate and submit materials to comply with local, state and federal regulations related to conducting oncology clinical trials in human subjects. Assist with the development and maintenance of the financial module management of clinical trials including the association of study milestones to study budget to confirm accuracy of invoicing and payment from study sponsors.
HOURS: 40 hours/week no weekends or holidays.
LOCATION: Lancaster, PA
ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:
- Prepare and process all regulatory documentation through all applicable review committees (such as IRB) including new submissions, continuing reviews, amendments, adverse events and reportable events all research protocols.
- Coordinate and participate in clinical trials required activities
- Responsible for knowing, tracking, and maintaining sponsor/cooperative group updates and regulatory requirements
- Responsible to assure correct version of consent and protocol are implemented.
- Maintain all regulatory documents for each investigator including current RCR, CITI, CV’s and medical license numbers.
- Assist with development of the financial module for clinical trials management
- Monitor and track study milestone completion and associate completion to study budget calendar for timely invoicing
- Maintain payment records from sponsor and corporate groups
SECONDARY FUNCTIONS: The following duties are considered secondary to the primary duties listed above:
- Provide program support for all team members
- Assist in development of tracking systems and report monthly
- Order supplies for unit including study lab kits
- Participate in monthly, multidisciplinary research team meeting and weekly department huddles.
- Attend conferences to maintain education on changes in federal and state regulations regarding human subjects and IRBs.
- Support of other study needs including IT ticket submissions for EMR builds and pharmacy data support as needed
- Assist with development and maintenance of Clinical Trials Management System
- Other duties as assigned.
MINIMUM REQUIRED QUALIFICATIONS:
- Associate’s decree or equivalent job related experience.
- Previous health care or related field experience.
- Strong attention to detail, organizational and multitasking skills.
- A health care provider in good standing with Medicare, Medicaid, and other federal and state health insurance programs, i.e. not excluded from participation in Medicare, Medicaid or any other federal or state health insurance program.
- Bachelor’s degree in a related field.
- Previous experience in research and/or regulatory.
Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The percentages of time spent performing job duties are estimates, and should not be considered absolute. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. Incumbent must be able to perform all job functions safely. #LI-MD1
PENN MEDICINE LANCASTER GENERAL HEALTH offers the following benefits to employees:
- 100% Tuition Assistance at The Pennsylvania College of Health Sciences
- Paid Time Off and Paid Holidays
- Shift, Weekend and On-Call Differentials
- Health, Dental and Vision Coverage
- Short-Term and Long-Term Disability
- Retirement Savings Account with Company Matching
- Child Care Subsidies
- Onsite Gym and Fitness Classes
Posted on 02/07/2023
PENN MEDICINE LANCASTER GENERAL HEALTH is an Equal Opportunity Employer, committed to hiring a diverse workforce. All openings will be filled based on qualifications without regard to race, color, sex, sexual orientation, gender identity, national origin, marital status, veteran status, disability, age, religion or any other classification protected by law.
Search Firm Representatives please read carefully: PENN MEDICINE LANCASTER GENERAL HEALTH is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at PENN MEDICINE LANCASTER GENERAL HEALTH via-email, the Internet or directly to hiring managers at Penn Medicine Lancaster General Health in any form without a valid written search agreement in place for that position will be deemed the sole property of PENN MEDICINE LANCASTER GENERAL HEALTH, and no fee will be paid in the event the candidate is hired by PENN MEDICINE LANCASTER GENERAL HEALTH as a result of the referral or through other means.