You haven't searched anything yet.
Experience conducting regulatory activities for Coordinating Center trials preferred.
Ensures that all federal regulations are adhered to and maintains up-to-date information regarding federal regulations and ethical considerations. Provides regulatory protocol training. Crafts and distributes applicable regulatory documents for research communities. Submits protocol reviews, verifies required documents, and handles complex issues.
Essential Functions-Prepares and maintains regulatory documents and Institutional Review Board (IRB) submissions
-Monitors, tracks and reports all Serious Adverse Events to IRB and Sponsor
-Ensures safety letters (i.e. MedWatch reports) are reviewed by the Principal Investigator and submitted to the IRB and external sites
-Oversees preparation of all closed study files for archiving in long term storage
-Serves as contact for research projects and maintains records and corresponds with all parties involved
-Develops and continuously monitors status reports detailing ongoing study submissions/approvals and/or renewal deadlines as required to ensure regulatory compliance for external sites
Physical EffortMust be able to sit or stand for prolonged period of time.
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
Assignment Category: Full-time regularPI240494354
Full Time
$65k-85k (estimate)
06/01/2024
06/16/2024
pitt.edu
MANVILLE, RI
15,000 - 50,000
1787
Private
TONY BORGES
$1B - $3B
Consumer Services
University of Pittsburgh is an educational institution that offers undergraduate and postgraduate degree programs for students.
The following is the career advancement route for Regulatory Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Specialist, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Specialist. You can explore the career advancement for a Regulatory Specialist below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Regulatory Specialist job description and responsibilities
The regulatory specialist creates and maintains regulations for testing processes, the development phase, how production operates and the marketing and distribution for new products.
04/06/2022: Wilmington, NC
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
04/13/2022: San Antonio, TX
Certified regulatory affairs specialists typically collect and review marketing, legal, regulatory and licensing documentation, case files, studies, reports, etc.
02/13/2022: Manchester, NH
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
02/10/2022: Santa Fe, NM
works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
04/11/2022: Baton Rouge, LA
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Regulatory Specialist jobs
Entry-level regulatory affairs professionals must have a bachelor’s degree.
02/23/2022: Chico, CA
Successful regulatory specialists are excellent writers, as they must write details and accurate reports for the evaluations they perform.
02/24/2022: Newport News, VA
Earn Regulatory Affairs Professionals Society certifications.
03/14/2022: Saint Paul, MN
On successful completion of the program, graduates can take up roles such as regulatory affairs specialists.
03/19/2022: Ann Arbor, MI
At conferences and forums, specialists develop their existing knowledge and learn about emerging regulations, standards, and guidance documents.
04/28/2022: Lowell, MA
Step 3: View the best colleges and universities for Regulatory Specialist.