Regulatory Affairs Specialist
Req Ref No: RPWARA11
Location: Issaquah, WA
Duration: 6 Months
The Clinical Research Associate (Temporary) provides compliance oversight for Good Clinical Practices, applicable regulatory standards, and client BA US Standard Operating Procedures. oversight by conducting on-site and remote monitoring of consent and study form documentation for on-going product development and internal validation activities.
In this role the Clinical Research Associate is also responsible for assessing existing human scanning documentation and functional processes for effectiveness in managing human scanning compliance, and working with key stakeholders to adapt processes/practices as needed to maintain compliance with federal regulations related to patient rights in clinical research. This role requires an intrapreneurial spirit, organizational creativity, a scalable process orientation, and a high tolerance for ambiguity within a regulatory compliant environment.
Ensure each of three ultrasound development facilities follows the IRB approved study protocols unique to each site and the site Principal Investigator maintains Study Binders that include:
o IRB Approval Letter
o Competed Case Report Forms (CRFs)
o Initial Review
o Continuing Review
o Adverse Event Reports
o Unanticipated Events
o Protocol Deviations
o Additional IRB Correspondence
Perform Study Documentation Review to ensure adequate training and adequate supervision, verified through:
o Review of Delegation log
o Review of Training log (training on investigational device and/or study protocol)
o Review of Enrollment Log
Verification of Control of Investigational Device by ensuring Device is administered only to those subjects enrolled in the study and under investigator’s or designee’s supervision.
Proactively work to improve systems and procedures and act as a cross-functional liaison with legal, quality, product management and clinical teams. May develop SOPs, processes, and templates to strategically standardize clinical tasks and improve efficiency
May contribute to developing study related materials; assists with writing reports and protocols.
• BA/BS degree in biological sciences or Medical Technology.
• 3-5 years’ experience in regulatory affairs, clinical affairs, clinical research, monitoring with experience in data analysis, statistics and word processing, or equivalent combination of education and experience.
• Experience drafting Clinical Evaluation Reports (CER) for European Medical Device Regulatory purposes a plus.
• Previous experience with imaging or medical device industry or clinical lab is desirable
• Must be a self-starter with strong technical writing, critical/analytical thinking and problem solving skills.
• Knowledge of ICH / GCP, EU MDR and FDA regulations desirable
• Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, RAPS) desirable.
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.