Kelly Services’ Outsourcing & Consulting Group (OCG) is seeking a Senior Clinical Trial Lead with cardiovascular experience for an open-ended assignment. The customer is based in Irvine, CA but candidates can be remote-based anywhere in the US. Candidates must have recent experience as a CRA/CTL supporting cardiovascular trials and previous monitoring experience. Experience with medical device knowledge is highly preferred.
Job duties include:
- Clinical study execution in support of the Client’s team and their overall Clinical Center of Excellence with a focus primarily on clinical cardiovascular studies.
- Fostering strong, productive relationships with colleagues within the organization.
- Serving as a member or leader of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility.
- Overall execution of small-medium-large regulated and non-regulated clinical projects or large non-regulated clinical projects including, but not limited to budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure.
- Providing support to department wide training.
- Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects.
- Leading several small/medium/large clinical studies (regulated and non-regulated) that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff.
- Assisting with or leading the management of large regulated studies alongside and in support of colleague CPMs or Senior CPMs and may support CPMs and/or Senior CPMs within a large or complex clinical study.
- Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities.
- Managing all activities of assigned clinical studies within the Clinical R&D Operations group.
- Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
- Evaluating support requests for publications and to provide consolidated comments and support to the requests.
- Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
- Tracking assigned projects budgets to ensure adherence to business plans.
- Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed
- Independently solves problems arising during clinical study execution and will seek guidance for more complex problems as needed
- Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
- Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
- Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
- May serve as the primary contact for clinical trial sites
- A minimum of a Bachelor’s Degree required: Life Science, Physical Science, Nursing, or Biological Science degree is preferred
- 5+ years of experience required as CRO- or Sponsor-level CRA or Clinical Project Manager
- 1+ years of Clinical Project Management experience
- Cardiovascular clinical trial experience
- Personnel management experience strongly preferred
- Medical device experience strongly preferred
- The ability to influence others along with strong written and oral communication skills is required
- Knowledge of Good Clinical Practices is required
- Understanding and application of regulations and standards applied in clinical areas is required
- Advanced project management skills with the ability to handle multiple projects required
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
This position comes with enhanced benefits which include:
- 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
- Paid holidays
- Paid sick days and vacation days*
Perks of being a Kelly employee:
- Weekly electronic pay
- Access to more than 3,000 online training courses though Kelly Learning center
- Online application system
- Never an applicant fee
*benefits to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.