Clinical Research Compliance Manager
15750 Alton Irvine, CA 92618 US
Job Description
Irvine based Medical Device/Technology company is adding to their team.
Under the direction of the Senior Clinical Program Manager, the Clinical Research Compliance Manager is responsible for managing all operational aspects for implementation of clinical trial activities from study start-up to database lock, ensuring compliance to applicable regulations, GCP, and relevant standard operating procedures.
All activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Department Operating Procedures (DOP).
Duties & Responsibilities
- Oversee the planning, implementation and close-out of clinical studies in support of project timelines and market release goals to ensure compliance with regulations and GCP.
- Provide training and oversight to staff maintaining clinical trial master files to ensure their compliance with relevant regulatory and GCP quality standards and consistency with SOPs
- Oversee and/or perform site monitoring (qualification, initiation, routine monitoring and close out visits).Manage monitoring schedule and monitoring resources to ensure studies are monitored in accordance to SOPs and monitoring plans.
- Provide input and support to maintain appropriate documentation of adverse events, device deficiencies, and protocol deviations, and collaborating in submission of MedWatch reports to FDA for events arising from clinical research activities.
- Identify potential risks and resolve issues relating to clinical research compliance
- Develop and implement process improvement initiatives to strengthen company clinical research study conduct and compliance.
- Provide support to the company QA during GCP inspections conducted by company-contracted third parties and external regulatory agencies.
- Provide support to sites to prepare for clinical audits and to respond to audit findings conducted by company QA and external regulatory agencies.
- Contribute to clinical study design, proposals, protocols, etc., understanding scientific content, experimental design, and analytical approaches used.
- Provide input and review study related materials such as clinical protocols, monitoring plans, data management plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all projects.
- Responsible for planning and resource leveling for all sponsored clinical studies.
- Provide support to company RA for submissions and strategy.
- Identify institutions, sites and investigators to collaborate on clinical research initiatives and studies.
- Interface with KOLs and Investigators.
- Work and communicate effectively with investigator, staff and patients in professional, sensitive and mature manner.
Minimum Qualifications
- Experience with medical devices preferred.
- Experienced with Good Clinical Practice (GCP) in conduct of clinical studies.
- Excellent written and verbal communication skills essential.
- Must be capable of interacting with all levels of management, coworkers, investigators and subjects
- Proficiency with Microsoft Office, computer data acquisition, data analysis, graphing and plotting results and report writing.
- Ability to independently set and manage multiple priorities.
- Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies.
- Ability to travel to data collection sites, local and domestic.
- Proven track record and experience in Clinical Research.
Preferred Qualifications
- Strong clinical background preferred. (e.g., respiratory therapy, nursing, pharmacology, physiology).
- Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements.
- Clinical Research Associate certification.
Education
BA/BS or equivalent years of experience required, preferably in life sciences. Advance degree in life sciences preferred.
Meet Your Recruiter
Nina McCann
On-Site Manager
A native to Orange County, Nina’s staffing career began in 2006 placing quality engineering candidates with distinguished companies as a successful recruiter and client manager. Nina specializes in recruiting for mechanical and electrical engineers in all industries from aerospace, medical device and manufacturing. She understands the engineering programs and importance of matching specific technical skills for position success. Her strong connections within the industry have been vital in her success. Nina’s excitement in placing engineers is due to the direct impact the products have on people’s lives: Everything we touch has been engineered in one form or another. She currently works as an on-site manager at a prominent medical device company.
Outside of work, Nina has been a dedicated volunteer to local nonprofit organizations for the past 15 years. She also enjoys being outdoors, hiking and spending time with her three children.