Job Description

Job Description

Job Description

Description:

POSITION SUMMARY

The Clinical Research Associate (CRA) will be responsible for monitoring clinical trials to ensure compliance with regulatory requirements, company SOPs, and Good Clinical Practice (GCP). The ideal candidate will have prior experience in clinical research within the aesthetic field or Class II medical devices.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential functions include, but are not limited to, the following:

• Coordinate activities related to the clinical trials between the clinical department at the headquarters and the study sites.
• Identify, initiate, monitor, and close clinical sites for aesthetic device clinical studies in accordance with protocols and regulatory standards.
• Conduct routine and for-cause site monitoring visits (on-site or remote), including qualification, initiation, interim, and close-out visits.
• Ensure site adherence to study protocols, GCP, FDA/ISO guidelines, and IRB requirements.
• Prepare monitoring visit reports, follow-up letters, and support maintaining Trial Master File (TMF) in accordance with SOPs.
• Provide protocol and device training to site personnel. Act as the primary liaison between the sponsor and study sites.
• Perform source data verification (SDV), query resolution, and support data entry accuracy in CRFs/eCRFs.
• Track investigational device inventory, usage, return, and reconciliation at clinical sites.
• Work with clinical team to support the clinical trails progress.
• Support the activities related to IRB including submissions, amendments, site approvals, study closures etc.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

• Bachelor’s degree in Life Sciences, Nursing, or related field required.
• 2–5 years of clinical monitoring experience, preferably in aesthetic medical device trials.
• Strong knowledge of FDA 21 CFR Part 812, ISO 14155, and ICH-GCP.
• Excellent communication, organization, and problem-solving abilities.
• Ability to travel up to 50% (within USA and Canada).
• Self-motivated and able to work independently or as part of a team.
• Familiarity with Class II aesthetic devices (e.g. ultrasound, lasers, RF, and injectables).
• Experience working in a startup or fast-paced driven environment.
• Prior involvement in FDA submissions or 510(k) support is a plus.

Benefits: The company provides a comprehensive benefits package, including health insurance plans, life insurance coverage, a 401(k) retirement plan with employer matching, and generous vacation and sick leave policies.

Sofwave is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law.

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