Lead Clinical Research Associate

Are you looking to work for a company that is expected to almost double in size within the next year or two? Do you have Clinical Research experience within the Medical Device Industry? Looking for a position that has potential to work a hybrid schedule?

What the company offers:

• Medical, Dental & Vision Insurance
• Bonus
• Stock Options
• 401k
• Life Insurance
• HSA/FSA

A Medical Device client in Orange County is looking to identify and hire a LeadClinical Research Associate on a full time, direct hire basis. The Lead Clinical Research Associate is responsible for assisting the Associate Director, Clinical Projects with orchestrating clinical operational activities as well executing high quality, integrated cross-functional plans for projects while adhering to appropriate standards and processes to ensure completion of project team goals in compliance with regulatory requirements.

The Lead Clinical Research Associate will be responsible for, but not limited to:

• Supporting study start-up activities such as assisting with IRB submissions, conduct training sessions for new site study staff, and oversee various start-up tasks.
• Verifying the accuracy and completeness of CRF data against source documents; assuring timely and complete data entry into eCRFs.
• Reviewing monitoring reports prepared by study monitors in adherence with SOPs and study plans.
• Identifying and escalating monitoring report issues/CAPAs to Associate Director, Clinical Projects.
• Maintaining monitoring timelines, key metric trackers/reports per defined milestones and timelines to assure that all deliverables are met.
• Verifying that research site personnel are conducting studies according to the protocol and that sites are in compliance with all applicable regulatory requirements & GCP guidelines through oversight including review of regulatory documents and preparing reports while adhering to project timelines/milestones.
• Serving as a liaison with research sites; monitoring the day-to-day conduct of the study and resolving problems associated with the study; providing administrative and logistical support as required.
• Interacting with clinical study sites to resolve data queries, errors and omissions, and obtaining additional information on various data related items.
• Participating in the planning of quality assurance activities and coordinate resolution of audit findings.
• Interacting with Clinical Operations group to ensure all site and personnel training is properly documented.
• Performing ongoing CTMF reconciliation on a quarterly basis.
• Overseeing study close-out activities.
• Maintaining and updating assigned trial spreadsheets and tracking tools.
• Supporting device accountability management.
• Supporting site regulatory inspection preparation and management.
• Proactive involvement in resolving issues; taking part in procedure improvement initiatives.

Requirements:

• B.A. / B.S. in life sciences or RN degree plus 5 + years’ experience in clinical trial monitoring or administration. Knowledge of medical device industry and/or ophthalmology experience strongly preferred.
• Demonstrated proficiency in GCPs and knowledge of other pertinent regulatory requirements.
• Candidate must be willing to work in Aliso Viejo office.
• Must be able to travel up to 20%.
• Well-organized and accustomed to maintaining excellent records.
• Able to manage multiple projects simultaneously.
• Must be detail oriented with well-developed organizational and analytical skills.
• Must enjoy working in a fast-paced startup environment with proven ability to be flexible and adaptable within a changing dynamic environment.
• Must have the interpersonal skills needed to communicate successfully with the Principal Investigators, Study Coordinators, and CRO.
• Must possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants
• Good problem-solving, organizational, and leadership skills are highly required.
• Ability to pay keen attention to detail at all times.
• Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects.
• Must be able to work as part of a team.
• Must have a ‘one of a kind’ work ethic, and must exhibit a great level of self-discipline.
• Ability to organize and motivate other members of the study team.