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15 days old

Lead Clinical Research Associate

Kelly Services
San Diego, CA 92108
Kelly Science and Clinical FSP is currently seeking a Lead Clinical Research Associate for a long-term engagement in the US with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**JOB GOAL:**

Provides administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations and SOPs. Close collaboration with other members within Clinical R&D. Effectively manages clinical study activities including design, planning, implementation, and overall direction of clinical research projects.


**RESPONSIBILITIES:**


+ Effectively manage multiple clinical studies/sites to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials while providing moderate level study management support.

+ Under the support of a Study Manager, contribute to study design, development, conduct and closure.

+ Create, review and/or revise key study documents, including but not limited to protocol, investigator brochures, informed consent document templates, monitoring plans, and annotated monitoring visit report templates.

+ Develop and implement a clinical trial training plan for internal and external personnel, including CRAs, CRA Assistants, and investigative site personnel.

+ Provide leadership, protocol and monitoring support to CRAs allocated to assigned clinical trials, including resolution of team member conflict and communication issues, with support from Regional Managers and others, as needed.

+ Responsible for study start-up activities including managing essential trial documents.

+ Review and approve completed monitoring visit reports.

+ Serve as primary contact for investigative site communication for each assigned site.

+ Train investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, international standards and local and national regulations.

+ Evaluate actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets

+ Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.

+ Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.

+ Preparing, submitting and filing of quality monitoring visit reports and associated follow-up letters in a timely manner.

+ Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance

+ Monitoring overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, Study Managers, Lead CRAs, CRAs and other clinical trial team members.

+ Maintaining audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.

+ Supporting study payment activities or accruals, as assigned.

+ Ensuring all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.


**QUALIFICATIONS:**


+ BA/BS or equivalent years of experience required.

+ 5+ years of clinical research experience with significant independent field monitoring experience is required.

+ Medical Device industry experience is preferred.

+ Knowledge of ophthalmology is preferred.

+ Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials, is required.

+ Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities is preferred.

+ Ability to problem-solve is required.

+ Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings is preferred.

+ Proficiency with MS Word, Excel and PowerPoint is required.

+ Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate is required.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-29 Expires: 2022-08-29

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Lead Clinical Research Associate

Kelly Services
San Diego, CA 92108

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