Description:

Will assist other regulatory coordinators with their duties. This position will focus primarily on pharmaceutical sponsor studies. This is a group of individuals who handle all of administrative work for the active and continuing studies regulatory work. Work will be organized for them; they will work from request forms that are built out for them. They will work with PIs, clinical coordinators and the IRB to make sure regulatory documents are approved and correct for all of the pharmaceutical research studies in medical oncology. The regulatory coordinators and assistants do not work with patients or in the clinics at all.

Regulatory Assistant Essential Functions

Credentials, Certifications & Signature Records

File current GCP, HSE, MLs, CVs, IATA for MedOnc staff

File current Wash U / BJC laboratory certifications (CAP & CLIA)

File current signature records for MedOnc staff

Study team updates

Add people to study team in myIRB

Add people to DOA log & send for PI signature via DocuSign

Add people to OnCore (investigators only)

Create FDF and update FDA 1572 (investigators only) & send to sub-I/PI via DocuSign

Misc. Startup Tasks

Add or update study team in myIRB

Add sub-Is to OnCore

Save initial email training acknowledgements in study training folder

Create DOA log draft

New Study Reg Packet Requests

Create initial FDFs, FDA 1572, PSP, IB AoR & send to sub-I/PI via DocuSign

PRMC Submissions

Change reviews

Continuing reviews (renewals)

Closures

Reg Doc Requests

Update reg docs at reg coordinator’s request

Master myIRB List

Update with new employee info, update current roles, update specific team info, remove staff who resign, etc.

Closed Studies

Maintain a list of all studies closed w/ the IRB and docs sent to Iron Mtn.

Monitoring Visits

Keep a list of upcoming visit dates w/ corresponding reg coordinators

Send link to monitors for access to regulatory BOX folder on day of visit

SIP (Shared Investigator Platform)

Creating site profile, adding site staff, updating as needed

Skills:

regulatory, IRB, clinical research

Top Skills Details:

regulatory, IRB, clinical research

Additional Skills & Qualifications:

Must have an associates or bachelors degree and be interested in clinical research, no prior research experience is necessary.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.