7272 Garden Grove, CA 92841
Clinical Research Associate
General Job Description:
The Clinical Research Associate has a supporting role in the planning, coordination, and execution of Hycor’s clinical performance studies. She/he must have excellent organizational skills, excellent verbal and written communication skills, have the ability to motivate and support teams and have in vitro diagnostic (IVD) technical skills and/or clinical research operational skills.
The Clinical Research Associate, through individual contribution will:
Support the overall day-to-day operations of multiple IVD clinical performance studies.
Assist in the development and management of Clinical Investigational Plans/Protocols and supporting clinical study materials.
Conducts routine and ad hoc meetings and written updates, with clinical affairs, cross-functional teams and company leadership to help drive projects and share key information.
Support effective and efficient study initiation through procedures and best practices in site qualification and development.
Support timely trial progress including site management for effective subject recruitment and protocol compliance.
Support clinical data integrity by monitoring practices through all phases of the studies.
Liaise with core-labs, contracted study vendors, and study committees, such as Steering and Data Monitoring Committees, as needed.
Have a good knowledge of GCPs, ISO 14155, and EN 13612.
Assist in preparation of Clinical Reports for regulatory submissions, including 510(k)s, international pre-market submissions, and Clinical Reports for other data dissemination activities.
Develop and maintain working relationships with CROs, contract clinical support staff, and site investigators and staff, including qualification, selection, budget, and work-scope negotiations and oversight.
Support development of and adherence to procedures and work instructions for key clinical research activities to ensure compliance and efficient study conduct.
Coordinate and support the preparation of clinical study reports and summaries on clinical trial results for internal review by other departments and senior staff. When appropriate, supports the preparation of manuscripts for publication of trial results in professional journals.
Create, manage and oversee the maintenance of all trial master files, at company and at investigational sites.
Be prepared for and manage on-site or remote regulatory audits by company or regulatory agency representatives.
Support company goals and objectives, policies and procedures, performance management programs, and applicable national and local regulations.
Act as a team member on project teams to provide clinical guidance in support of new product development and existing product support.
Participate in and review risk management activities/documents and ensure compliance with ISO 14971.
Work directly with medical affairs and complaint handling staff to facilitate accurate adverse event reporting.
Maintain a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to quality and integrity.
Support commercialization activities for product lines globally, according to local and regional regulatory and quality requirements.
Lead projects of various scope and size, as assigned.
Perform other duties, as required or assigned.
Have strong planning, organizational, and communication skills.
Have computer knowledge consisting of email, Word, Excel, Project, Visio, Adobe Acrobat Professional, and other basic skills.
Have excellent judgment, a positive driver attitude, be customer oriented, and a team player.
Education: Bachelor Degree in Science or Medical Technology
Licenses/Certifications: Clinical Research Associate Certification (CCRA and/or CCRP) is a plus.
Skills/Abilities: Ability to work independently. Excellent oral, written, organizational, and analytical skills. Good understanding of IVD products, immunoassays, IVD instruments and software, and general clinical lab materials and supplies. Ability to represent the clinical department in frequent inter-organizational meetings. Ability to perform work with minimal direction and supervision. Ability to provide solutions to difficult technical issues associated with specific projects.
Minimum of 5 years of experience in diagnostics, life science, or medical devices with a minimum of 2 years in clinical research and, ideally, at least 1 year of IVD specific clinical research. IVD assay development experience is a plus.
Demonstrated ability to successfully support clinical studies to meet business goals using standard best practices and compliance norms.
Demonstrated ability to work successfully on cross-functional teams.
Good knowledge of GCPs, ISO 14155, and EN 13612.
Working knowledge of IDEs, 510(k)s, and IVDD/IVDR.
Working knowledge of ISO 13485, Quality System Regulation, and relevant international standards.
Working knowledge of medical device risk management standards and guidance documents, specifically ISO 14971.
Proven track record of maintaining clinical knowledge and skills by participating in industry conferences/seminars.
Must be available and willing to work flexible schedules, as needed.
Must be able to travel, up to 30%.
Prior experience with GCP and internal audits.
Strong working knowledge of problem solving and statistical methods, as applied to clinical studies.
Good understanding of medical treatment aspects related to IVDs for allergies and auto-immune diseases.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or regulations.
Ability to independently determine and develop approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
Application Information & Contact (How to Apply)
To apply, please email resume to LCristobal@hycorbiomedical.com