Job Title: Regulatory Assistant
Job Description

Assist other regulatory coordinators with their duties, focusing primarily on pharmaceutical sponsor studies. This role involves handling administrative work for ongoing and continuing studies in medical oncology. The work will be organized through request forms and involves collaboration with PIs, clinical coordinators, and the IRB to ensure regulatory documents are approved and accurate. Note that there is no patient or clinic interaction involved in this position.

ResponsibilitiesFile current GCP, HSE, MLs, CVs, and IATA for MedOnc staff.File current Wash U/BJC laboratory certifications (CAP & CLIA).File current signature records for MedOnc staff.Add people to the study team in myIRB.Add people to the DOA log and send for PI signature via DocuSign.Create and update FDF and FDA 1572 forms (investigators only) and send to sub-I/PI via DocuSign.Save initial email training acknowledgements in the study training folder.Create DOA log drafts.Handle new study submissions including initial FDFs, FDA 1572, PSP, IB AoR, and send to sub-I/PI.Manage change reviews, continuing reviews (renewals), and closures.Update regulatory documents at the request of the regulatory coordinator.Maintain and update the master list with new employee information, current roles, specific team info, and staff changes.Maintain a list of all studies closed with the IRB and documents sent to Iron Mountain.Keep a list of upcoming monitoring visit dates and corresponding regulatory coordinators.Send links to monitors for access to regulatory BOX folder on the day of visits.Create and update site profiles, adding site staff, and making necessary updates in the Shared Investigator Platform (SIP).Essential SkillsExperience with regulatory, IRB, and clinical research.Proficiency in Microsoft Office Suite.Understanding of medical terminology.Ability to prioritize tasks effectively.Additional Skills & QualificationsAssociates or bachelor's degree.Interest in clinical research.No prior research experience necessary.Work Environment

This is a hybrid work environment. After the training period, you will come into the office twice a month. During the training period, on-site attendance is required at least once a week, potentially more. This role offers a great opportunity for career advancement and entry into the field of clinical research.

Pay and Benefits

The pay range for this position is $20.00 - $20.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in St. Louis,MO.

Application Deadline

This position is anticipated to close on Feb 20, 2025.

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.