Clinical Research Site Operations Manager
$90k - $105kKelly Services
Job Description
Job Description
Clinical Site Operation Manager
- Employment: Direct Hire/Permanent, Fulltime, M-F, Onsite
- Location: Inglewood, CA (Must be onsite)
- Salary: $90 - $105k annually (Additional quarterly bonus opportunity)
- Manage and train clinic site personnel.
- Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business plan.
- Oversee the implementation and maintenance of quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs.
- Manage Site Budgets / Expenses
- Work with the Medical Director/PI to address any study and/or clinical quality related matters.
- Ensure timely and appropriate communications occur with Sponsors and IRBs, as necessary.
- Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies.
- Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies.
- Read, comprehend, and communicate study protocols and oversee SIV, PSDV and IMV.
- Manage and facilitate study startup documentation, training, supplies and timelines of study protocols.
- Develop and implement operational plans, timelines, and budgets for clinical trials.
- Monitor study progress, resolve data issues, and prepare status reports for leadership.
- Work closely with CRO/CRA/IRB.
- Maintain site regulatory files.
- Document temperatures for IP stored on-site.
- Audit study e-source documentation to comply with study protocols.
- Support audits and inspections
- Monitor study metrics and key performance indicators (KPIs)
- Perform other duties as assigned.
- Bachelor’s degree preferred in healthcare or equivalent clinical research experience.
- 5+ years of clinical management experience
- 3 years' experience working as a Clinical Research Coordinator, required.
- Comprehensive knowledge of FDA, GCP & confidentiality.
- Proven success in managing teams and working in direct patient care, required.
- Proficient problem-solving skills & conflict resolution.
- Proficient in Microsoft Word, Excel and PDF.
- Excellent verbal and written communication skills.
- A proven ability to constantly prioritize multiple projects in a rapidly changing environment.
- Must be comfortable with a rapid-growth company.
- Monitor project timelines and ensure milestones are met
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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