Regulatory Specialist - PSD

Description

As a Regulatory Specialist you will prepare regulatory documentation and maintain research and clinical databases. You will also coordinate the submission and evaluation of clinical studies by regulatory processes from study approval to closure and develop clinical protocols to maintain regulatory compliance.

Responsibilities:

• Coordinate research data collection and presentation processes to include: create database/spreadsheets, present information on research studies and their progress, and manuscript preparation, review, and submission.
• Organize, track, and disseminate information on research studies, their progress and data for PI.
• Coordinate informed consent process for research studies to include: obtaining consents from patients and train departmental staff.
• Identify, record, and verify research study eligible patients.
• Participate in research, staff, and multi-disciplinary meetings.
• Perform database queries/searches to identify patient populations studied for clinical follow-up and disseminate results to all appropriate parties.
• Complete and maintain required training for clinical research and database management including IRB certification modules.
• Liaise with other departments (i.e. CTSI, HSTB, Pathology, OR nurses, OR Scheduling, Same-day surgery, SMH, Phlebotomy etc.) to ensure timely and accurate research data and sample collection and storage.
• Prepare IRB protocols (including literature searches and consent forms), modifications, renewals (including DSMP reports) and other regulatory documentation associated with the research study.
• Interact with the Primary Investigator (PI) and IRB to facilitate submissions, modifications, renewals, end of study reports, etc. for the research protocol.

Qualifications

• Minimum BS degree required in a health, public health, business, science or related field.
• Knowledge of clinical research regulations including Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) is expected, preferably with 1 years experience in clinical or scientific research functions, with demonstrated excellence in the following general requirements: writing, communication, computer applications (Access, Excel, and Word), and interpersonal skills.
• Exceptional writing, planning, and organizational skills are required to prepare clinical study protocols, regulatory submissions and various scientific and medical-related reports to contribute to the overall Clinical and Regulatory effort.
• Preparation and maintenance of IRB submissions and the ability to appropriately summarize data for inclusion in requisite reports is necessary.
• Position requires either previous clinical research experience or combined experience in clinical, scientific, and administrative positions, along with a strong working knowledge of study design.
• Previous work or strong knowledge of oncology is preferred.
• Strong communication, presentation and computer and database knowledge skills are required.
• Strong administrative background preferred
• Strong attention to detail
• Must be capable of functioning independently with minimal supervision as well as perform and follow up with multiple projects.

Licensure, Certifications, and Clearances:

• Act 31 Child Abuse Reporting with renewal
• Act 33 with renewal
• Act 34 with renewal
• Act 73 FBI Clearance with renewal

UPMC is an Equal Opportunity Employer/Disability/Veteran

Salary : $25 - $43