Whoop
Temporary Clinical Research Associate
Boston, MA. Posted 3 months ago
The role
You will provide monitoring and clinical operations support across WHOOP's clinical research studies. You will support studies through startup, active conduct, monitoring, and closeout.
What you will do
- Conduct remote and onsite monitoring activities including Site Initiation Visits, Interim Monitoring Visits, and Closeout Visits.
- Perform monitoring activities in accordance with protocols, monitoring plans, Good Clinical Practice, regulations, and WHOOP procedures.
- Review informed consent, participant eligibility, source documentation, case report forms, protocol adherence, safety documentation, and study data.
- Prepare monitoring visit reports, follow-up communications, action-item trackers, and study status updates.
- Identify, document, track, and escalate protocol deviations, data quality concerns, safety issues, compliance risks, and operational challenges.
- Support site readiness activities including review of essential documents, training completion, systems access, and operational preparedness.
- Assist with site and study team training on protocols, study procedures, documentation requirements, and clinical systems.
- Create and maintain assigned study logs, trackers, monitoring templates, and clinical operations documentation.
- Collaborate with Clinical Operations, Clinical Science, Clinical Research Coordinators, Data Management, Regulatory, Quality, investigators, research sites, and external vendors.
- Support study closeout activities including document reconciliation, action-item resolution, final monitoring activities, and Trial Master File completion.
Required qualifications
- Bachelor's degree in life sciences, nursing, public health, clinical research, or a related field, or equivalent relevant experience.
- 3+ years of experience in clinical research, including at least 1 year performing clinical monitoring or CRA responsibilities.
- Strong attention to detail and the ability to identify and clearly document study risks, compliance concerns, and data quality issues.
- Strong written communication skills, including the ability to prepare clear monitoring reports and site follow-up correspondence.
Nice to have
- Experience supporting medical-device, digital-health, wearable-technology, or remote-monitoring studies.
- Familiarity with ISO 14155 or clinical research involving medical devices.
- Experience working in a sponsor, CRO, or research-site environment.
- Experience supporting studies related to cardiovascular health, women's health, sleep, metabolic health, or digital biomarkers.
About the company
WHOOP is on a mission to unlock human performance and healthspan. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.