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 Senior Clinical Research Associate (CRA) you will be a key player in managing clinical trials from start to finish, ensuring that projects are executed efficiently, within budget, and in compliance with regulatory guidelines. You will provide leadership in site management, remote monitoring, and communication between stakeholders to ensure seamless trial execution.
You will play a crucial role in overseeing site activities, from study initiation to close-out, including site monitoring, investigator training, and protocol adherence. Your expertise in managing external sites remotely and on-site, combined with your deep understanding of clinical trial regulations, will ensure the success of our trials. You will also oversee the preparation and submission of regulatory documents, track study timelines, and maintain regular communication with sponsors, investigators, and internal teams.
On the project management side, you will coordinate all aspects of clinical trials, including protocol development, budget tracking, and milestone management. You will proactively manage risks, resolve issues, and ensure trial activities align with project goals and regulatory requirements. Your leadership will be essential in managing cross-functional teams, ensuring that trials are completed on time, and within scope.
RESPONSIBILITIES:
- Site Management: Manage all aspects of site activities, including site selection, initiation, monitoring, and close-out visits, ensuring adherence to protocol and regulatory requirements
- Remote Monitoring: Oversee and perform remote site management, ensuring data integrity, protocol compliance, and timely reporting
- Investigator Training: Train investigators and site staff on protocol, study objectives, and regulatory requirements
- Study Planning & Oversight: Develop study plans, including timelines, budgets, and resources, and ensure their alignment with project objectives
- Regulatory Documentation: Assist in the preparation, submission, and follow-up of regulatory documents, including IRB submissions, protocol amendments, and safety reporting
- Risk Management: Proactively identify potential risks and implement mitigation strategies to ensure smooth trial execution.
- Stakeholder Communication: Maintain clear and proactive communication with sponsors, investigators, and cross-functional teams to ensure alignment and resolve any issues promptly
- Data Integrity: Ensure that all site data and documentation are accurate, complete, and in compliance with Good Clinical Practice (GCP) and regulatory standards
- Close-out Activities: Oversee site close-out processes, ensuring all study-related documentation is reconciled and submitted on time
QUALIFICATIONS:
- Bachelor’s degree in Life Sciences, Clinical Research, or a related field
- 3+ years of experience in clinical research, with a focus on clinical trial management and site monitoring
- Strong knowledge of FDA regulations, ICH-GCP guidelines, and international clinical research requirements
- Proven ability to manage multiple sites and complex clinical trials, both remotely and on-site
- Excellent organizational skills, with the ability to manage timelines, budgets, and project deliverables
- Strong written and verbal communication skills, with the ability to collaborate across teams and manage stakeholders
- Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems
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
