What are the responsibilities and job description for the Clinical Research Site Operations Manager position at Kelly Science, Engineering, Technology & Telecom?
Clinical Site Operation Manager
- Employment: Direct Hire/Permanent, Fulltime, M-F, Onsite
- Location: San Diego CA
- Salary: $90 - $105k annually (Additional quarterly bonus opportunity)
Kelly Science and Clinical is hiring a Clinical Operations Manager for one of our growing clinical research site networks. This person will oversee the day-to-day functions of the clinic, manage the office personnel, as well as manage daily operational and administrative activities. This individual will act as a liaison between patients, medical staff, clinic staff, and management to ensure optimal clinic functioning. Additionally, the Manager will play an essential role in ensuring policies and procedures, ensure that the clinic delivers exceptional patient care, and function efficiently.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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.
EDUCATION and EXPERIENCE:
- 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
Salary : $90,000 - $105,000