Regulatory Affairs Specialist

Minneapolis, MN

Job Description

Regulatory Specialist's needed for a clinical trial.

The Regulatory Specialist facilitates the compliant execution of clinical trials, and assists in the development and maintenance of regulatory documents and standards within the group.

Long term opportunity!

Qualified candidates will have the following skills and abilities

  • Facilitates compliant execution of cancer clinical trials

  • Maintains and applies current working knowledge of relevant federal, state and local laws and regulations and University policies regarding research activities

  • Creates and maintains documents and ensures that all are filed and archived properly in accordance with regulatory agency requirements

  • Adapts informed consents to comply with local standards

  • Acts as liaison with sponsor, principal investigator, subject coordinator, review committees and monitors to facilitate regulatory compliance in the start-up, management and close-out clinical trials

  • Monitors trends in regulatory processes and makes recommendations for improvement

  • Serves as a resource to improve regulatory compliance within clinical research

  • Maintains regulatory binders for assigned trials that are audit-ready at all times

  • Ensures that protocols are submitted to all required committees and regulatory-entities and facilitates their progress through the approval process

  • Ensures that regulatory binders contain all essential documents and ar-e kept up-to-date Ensures that all regulatory reviews are entered and appropriate documents uploaded in Oncore in a timely manner

  • Submits study documents to the various review committees within set time goals

  • Has familiarized his/herself with IRB's consent t-emplate and required language and is able to adapt external sponsor's consent forms to meet the IRB's requirement

  • Develops effective means of communicating with Pis, sponsors, research staff and review committees to ensure that regulatory documents are processed in a timely manner

Requirements

  • Bachelor degree or a combination of relevant education and clinical research experience equal to 4 years

  • Experience working in an Institutional Review Board

  • Relevant experience with clinical research

  • Working knowledge of Microsoft applications (Word, Access, Excel, etc.)

  • Excellent attention to detail and organizational skills

Schedule

Monday through Friday 8am to 4:30pm

Post Date: 05.07.2021

Salary: Contact for Rate

Shift: AM

Interested in this Job?

Please Login, Register or you can apply as a guest

Sign In

If you would prefer to speak directly to an Clinicor Staffing Consultant, please call us at 612-977-1470 and reference OrderID 815651


Like what you see? Share this job opening with your friends and family.

Your job is caring for others - let us care for your career!

If you are looking for per diem, contract staffing or direct hire placement look to Clinicor Medical and Clinical Staffing. You will not find another medical staffing agency in Minnesota that will work as hard to effectively and consistently match your lifestyle that meets your professional goals.

We offer healthcare opportunities that encompass a wide variety of healthcare specialties: Medical Nursing, Allied Health, Clinical Research and Medical Administrative.

As a member of Clinicor’s dynamic healthcare team, we offer competitive pay and you will enjoy comprehensive benefits, flexible scheduling options and rewarding assignments in an environment suited just for you.

We invite you to apply today to become a member of our team!

Clinicor Medical and Clinical Staffing is an Equal Opportunity Employer.