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Regulatory & Systems Access Manager

Care Access

Responsibilities:

  • Will supervise the team that maintains, updates, and indexes Staff Training Files / Credentialing and other Regulatory files.
  • Work with, correspond, and communicate with all Vendors Managers for updated, missing, and new staff training, credentials, and regulatory documents.
  • Assist and coordinate with Training and Simulations Managers in developing Training plans per protocol and study roles.
  • Will manage the team of onboarding specialists and work with Functional Leads and Study Managers to ensure Care Access and vendor staff is deployment-ready (for each decentralized deployment) from a regulatory and training compliance standpoint (will include trial-specific and industry-standard trainings).
  • Will work with Quality and Compliance Officer and Study Managers to assist with internal and external audits, inquiries, and investigations related to training other research-related compliance issues.
  • Develop detailed action plans for improving training compliance and following up to ensure that these plans are implemented in a timely manner. Collaborate with central regulatory, QA, and compliance departments to ensure inspection readiness.
  • Perform access reviews to ensure access to resources & job functions.
  • Ensure compliance with industry regulations and respond to audits as it pertains to access & training requirements.
  • Preserve all records that indicate changes made to access control lists to facilitate audits and other investigations.
  • Assist with audit preparations and help develop response and action items for an associated finding. Oversee team to update and close tasks related to access management requests and meet study targets.

Requirements:

  • Masters Degree or foreign equivalent in Regulatory Affairs, Regulatory Compliance or a related field.

Please Reference Job Number #498706 when sending resumes. Please mail resumes to: HR, Care Access Research, LLC, 33 Arch Street, 17th Floor, Boston, MA 02110.

At Care Access, every day we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. The work that we do brings life-changing therapies to those who are in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and to work with the big players while also engaging with the very best physicians and caring for patients. Through innovation and a unique technology-enabled service model, our team of experts is paving the way to take this vision forward.

We care. Our values are rooted in being genuine, finding new ideas, and building something meaningful. Influenced by our values, we have built a culture valuing communication and dialogue: we care about what everyone has to say and we spend energy on being equal and inclusive. Along the way, we are caring for each other, accelerating medicine, and seeding a long-term impact for generations to come.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

By applying to this post, you agree to receive text message updates about your application and interview process.

Expected salary:

Job date: Fri, 14 Oct 2022 00:07:11 GMT

Regulatory & Systems Access Manager

To apply for the job click here

Regulatory & Systems Access Manager

To apply for the job click here

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Care Access

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