Regulatory Affairs Manager jobs in Tacoma, WA

Department of Clinical Investigation, Madigan Army Medical Center (MAMC) is looking for a Research Assistant to assist with the administrative aspects of the department. In particular they would assist with:

* Administer and process submitted research protocols by reviewing for research regulatory compliance and adequate protocol development using specified criteria and experience.

* Serve as point of contact to advise prospective investigators on technical (legal and other formal criteria) and procedural requirements for protocol development.

* Answer inquiries, provide detailed briefings and guidance on preparing studies in proper format with particular emphasis on volunteer consent agreements and other regulatory aspects.

* Review all research projects to assure that the investigator has complied with regulations pertaining to the administrative conduct of research and assures conformance with pertinent Army, Health Services Command (HSC), Madigan, Health and Human Services (HHS), and Federal Food and Drug Administration (FDA) regulations.

* Review and edit human subject volunteer consent agreements to ensure that all appropriate regulatory elements are contained, that the volunteer agreement contains details of their involvement at the appropriate educational level for the research subject, to include pediatric patients.

* Serve as an assistant to the compliance auditor for Madigan research program, consisting of approximately 200 on going, research protocols that received approval by the Institutional Review Board (IRB). As an assistant to the compliance auditor, develop and conduct detailed analyses and evaluative methods/techniques of function, and work processes, including research audit procedures. Maintaining the efficiency and effectiveness of the program. Responsible for using, creating, and adapting specific protocol checklists for auditing purposes, managing progress, protocol performance, data collection/recording. With that knowledge make recommendations, substantive solutions and the proper reporting of audit results. Manage and schedule audits by use and maintenance of an established database. Adheres to that schedule of periodic audits and inspections of Madigan principal investigators and their patient records. Notifies and meets with principal investigators on-site to communicate results of audits and review of research patient records, using appropriate checklists.

* Reviews the Federal Register and new or revised regulations to include Madigan, HHS, FDA, USDA, and other issuances pertinent to the investigative program and human research regulation. Based upon these reviews, cooperatively develop local guidance/instructions and recommends implementation into Madigan’s Human Research Protections Office (HRPO).

Experience required: Two years' work experience related to medical research and/or regulatory compliance.

Skills required:

* Read, write, and speak English well enough to effectively communicate with all parties as well as other health care professionals.

* Computer experience and a moderate dexterity with Microsoft products such as Word, Excel, PowerPoint, and SharePoint.

* Possess sufficient initiative, interpersonal relationship skills and social sensitivity such that he/she can relate constructively to coworkers from diverse backgrounds as well health professionals.

* Possess the required education, training, experience, and documented current competence in the required specialty position description with experience in a medical/research setting.

* Ability to be part of a cohesive team as well as be able to work independently.

* Adhere to all IT requirements for utilizing Government equipment and accessing Government systems.

Job Type: Full-time

Pay: From $50,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• PLEASE ANSWER THIS QUESTION TO BE CONSIDERED... Select one or more options that apply to you - (1) I am a US citizen (2) I have been in the US for 3 out of the previous 5 years (3) I have an active Tier 1 NACI (SF85) investigation that was conducted in the last 5 years?

Education:

• Bachelor's (Required)

Experience:

• medical research and/or regulatory compliance: 2 years (Required)

Security clearance:

• Confidential (Required)

Ability to Commute:

• Joint Base Lewis McChord, WA 98431 (Required)

Work Location: In person