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Clinical Regulatory Affairs Specialist

Massachusetts, United States (Hybrid)

Clinical Regulatory Affairs Specialist

1 Month ago • 3 Years + • Legal

About the job

3 skills required for this role

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quality-control

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organisational-skills

Job Description

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WHOOP is an advanced health and fitness wearable, on a mission to unlock human performance. WHOOP empowers its members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.

As the Clinical Regulatory Affairs Specialist, you will play a critical role in managing essential documentation and regulatory submissions that are key to our clinical trials' success. Your responsibilities will span from preparing and submitting IRB documentation to ensuring the proper setup and maintenance of e-TMF systems throughout the trial lifecycle.

You will ensure the success of clinical trials by overseeing the submission of regulatory packages, managing IRB approvals and amendments, and handling ongoing updates of study documents. Your expertise will be crucial for ensuring compliance with local and international regulations, facilitating seamless coordination between study sites, regulatory bodies, and internal teams. Additionally, you will take ownership of study document reconciliation, ensuring that all records are complete at the conclusion of trials.

On the operational side, you will manage the setup and periodic review of electronic Trial Master Files (e-TMF) and ensure study documentation is properly maintained across multiple sites. You will collaborate with cross-functional teams to ensure that protocol revisions, Clinical Study Reports (CSR), and safety specifications are thoroughly documented and submitted on time. You are responsible for ensuring a high level of accuracy and quality control in all documentation-related processes.

RESPONSIBILITIES:

Regulatory Submissions: Prepare, submit, and manage IRB documentation, including protocol amendments, annual submissions, and follow-up queries
e-TMF Management: Set up, maintain, and perform regular quality checks on e-TMF systems, ensuring proper documentation is uploaded and compliant with regulatory standards
Document Control: Oversee updates to study documentation, including protocol revisions, Master Informed Consent Forms (ICF), and Clinical Study Reports (CSR) during the course of the study
Compliance: Ensure compliance with local and international regulations, including FDA, ICH-GCP, and other relevant guidelines.
Site Management: Collaborate with clinical teams to deliver study site documentation and manage the collection of essential regulatory documents from sites
Study Reconciliation: Perform reconciliation of site and study documentation at the end of the trial, ensuring all records are complete and transferred to the sponsor
Safety Documentation: Prepare and submit safety specifications and other regulatory-required safety documents

QUALIFICATIONS:

Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field
3+ years of experience in regulatory affairs or clinical trial documentation within the pharmaceutical, medical device, or biotech industries
Strong understanding of FDA regulations, ICH-GCP, and international regulatory requirements
Experience with Decentralized clinical trials (DCTs) is a plus
Experience with electronic Trial Master File (e-TMF) systems and document management systems
Excellent attention to detail, organizational skills, and the ability to manage multiple projects simultaneously
Strong written and verbal communication skills for collaborating with cross-functional teams

This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.

Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.

WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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