Clinical Research Associate (CRA)
Hybrid | San Diego, CA
6-Month Contract-to-Hire Opportunity
Full-Time | Monday–Friday
Join a growing clinical research team at a leading medical device company as a Clinical Research Associate (CRA). In this role, you will support the planning, coordination, execution, and monitoring of clinical research studies across multiple sites. This role will partner with clinical sites, vendors, CROs, and internal stakeholders to ensure studies are conducted in compliance with Good Clinical Practice (GCP), regulatory requirements, and study protocols.
Responsibilities include study start-up activities, site coordination, EDC monitoring, data review, regulatory documentation, participant tracking, and overall operational support throughout the clinical trial lifecycle.
Clinical Research Associate Key Responsibilities:
Clinical Study Operations
- Support study planning, start-up, execution, monitoring, and closeout activities for clinical research studies.
- Coordinate daily study activities with clinical sites, vendors, CROs, and internal stakeholders.
- Train and support research sites on study protocols, procedures, and documentation requirements.
- Monitor study progress and ensure compliance with protocols, GCP, and regulatory standards.
- Track enrollment, retention, participant visits, protocol deviations, adverse events, and study milestones.
Data Management & Monitoring
- Perform Electronic Data Capture (EDC) monitoring and centralized data review activities.
- Review case report forms (CRFs), manage queries, reconcile data, and follow up on missing information.
- Maintain study dashboards, metrics, enrollment reports, timelines, and operational trackers.
- Document findings and support data quality initiatives.
Regulatory & Documentation Support
- Maintain Trial Master Files (TMF) and site regulatory documentation to ensure inspection readiness.
- Support IRB submissions, amendments, regulatory filings, and study documentation updates.
- Assist with audit and inspection preparation, document review, and corrective action tracking.
- Prepare and maintain protocols, informed consent forms, training materials, study reports, newsletters, and source documentation.
Site & Participant Support
- Coordinate study supplies, equipment shipments, and device accountability activities.
- Support approved recruitment initiatives, participant outreach, prescreening, scheduling, and follow-up activities.
- Assist with patient visits, documentation, data entry, and study-related follow-up as needed.
- Support registry initiatives and research database maintenance.
Clinical Research Associate Qualifications:
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field.
- 2+ years of experience as a Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), or similar clinical research role.
- Experience supporting clinical studies, clinical trial operations, or research site coordination.
- Hands-on experience with Electronic Data Capture (EDC) systems.
- Working knowledge of Good Clinical Practice (GCP), informed consent processes, clinical monitoring, adverse event reporting, and clinical study documentation.
- Strong organizational, analytical, and problem-solving skills.
- Excellent written and verbal communication abilities.
- Ability to manage multiple priorities and work independently with minimal supervision.
- Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Experience with clinical trial management systems, EDC platforms, and study tracking tools.
- Ability to utilize digital tools and technology platforms to support study operations and documentation.
Clinical Research Associate Preferred Qualifications:
- CRA certification (CCRA, CCRP, CCRC, or equivalent).
- Current GCP certification.
- Experience supporting medical device clinical studies.
- Experience with FDA-regulated clinical research.
- Background in sleep medicine, respiratory care, polysomnography (PSG), respiratory therapy (RT), or sleep research.
- Experience interacting directly with research participants and clinical sites.
- Knowledge of ClinicalTrials.gov submissions and clinical evidence-generation activities.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:
Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.
REQUESTING AN ACCOMODATION
Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.
PAY TRANSPARENCY POLICY STATEMENT
Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington as set forth below.
Clinical Research Associate Pay Range: $40-$50/hr. DOE
Pay: $40.00 - $50.00 per hour
Application Question(s):
- Do you have experience with Sleep Medicine, Respiratory Therapy, Sleep Labs, or Polysomnography?
- Do you have experience supporting or coordinating clinical studies from study start-up through execution and closeout?
- Do you have hands-on experience using Electronic Data Capture (EDC) systems for clinical studies?
- Do you have at least 2 years of Clinical Research experience as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC)?
Work Location: Hybrid remote in San Diego, CA 92123
