Temporary Clinical Research Associate

United States Digital Space LLC; Boston (MA); Hybrid; USD 52,000 - 72,000; Full time

Job summary

United States Digital Space LLC is seeking a Temporary Clinical Research Associate to provide monitoring and clinical operations support across our portfolio of clinical studies. This includes startup, active conduct, monitoring, and closeout activities, with remote and onsite visits as needed.

The successful candidate will review documentation, support Trial Master File quality, track issues, and ensure adherence to approved protocols, GCP, regulations, and company procedures.

Qualifications

• Bachelor’s degree in life sciences, nursing, public health, clinical research, or related field, or equivalent.
• 3+ years of clinical research experience, including at least 1 year performing CRA responsibilities.
• Strong attention to detail and ability to identify and document study risks, compliance concerns, and data quality issues.
• Strong written communication skills, including monitoring reports and site follow-up correspondence.

Responsibilities

• Conduct remote and onsite monitoring activities for assigned studies, including Site Initiation Visits, Interim Monitoring Visits, Closeout Visits, and other study-specific visits.
• Perform monitoring activities in accordance with approved protocols, monitoring plans, Good Clinical Practice, applicable regulations, and company procedures.
• Review informed consent documentation, participant eligibility, source documentation, case report forms, protocol adherence, safety documentation, and study data for accuracy and completeness.
• Prepare accurate and timely 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.

Skills

Monitoring

Communication

Documentation

Education

Bachelor’s degree in life sciences or related field

Job description

At the company, we're on a mission to unlock human performance and healthspan. the company empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.

As a Temporary Clinical Research Associate, you will provide monitoring and clinical operations support across the company’s portfolio of clinical research studies. You will support assigned studies at various stages of the clinical lifecycle, including startup, active study conduct, monitoring, and closeout.

You will conduct monitoring activities, review study documentation, support Trial Master File quality, track study issues, and help ensure that studies are conducted in accordance with approved protocols, Good Clinical Practice, applicable regulations, and the company procedures.

This role requires a detail-oriented and collaborative CRA who can independently manage assigned monitoring activities, communicate effectively with research sites and internal teams, and escalating risks or compliance concerns appropriately. Depending on study timelines and business needs, you may support one or more studies during the contract period.

This is a 6 month, temporary position with an hourly pay rate of $45/hr.

Responsibilities

• Conduct remote and onsite monitoring activities for assigned studies, including Site Initiation Visits, Interim Monitoring Visits, Closeout Visits, and other study-specific visits.
• Perform monitoring activities in accordance with approved protocols, monitoring plans, Good Clinical Practice, applicable regulations, and the company procedures.
• Review informed consent documentation, participant eligibility, source documentation, case report forms, protocol adherence, safety documentation, and study data for accuracy and completeness.
• Prepare accurate and timely monitoring visit reports, follow-up communications, action-item trackers, and study status updates.
• Identify, document, track, and escal 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.

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.

Desired

• 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.