Job Details

Clinical Operations Manager

Kelly Science and Clinical is hiring for one of our growing Site Network Clients to work as a direct employee onsite in San Diego CA.

• Opportunity

  Direct hire

  
  

• Location: San Diego CA – On-site
• Travel: 5-10% as needed
• Salary: 95,000.00 – 105,000.00 annually
• In addition to benefits such as Medical, Dental, Vision, 401k, PTO and more

About the Company:

We are people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research, diligent patient care and strong executive management. Our hands-on management team and medical staff are committed to rapid, efficient trials that bring life-changing drugs to market faster; our research staff brings years and years of "in the trenches" experience conducting Phase 1-4 clinical studies. And each one is dedicated to curing disease and improving individual quality of life.

Mission Statement:

Our mission is to advance medical research by enrolling diverse populations in high-quality clinical trials. We are committed to maintaining the highest standards of integrity and excellence, and to ensuring that every participant receives respectful and compassionate care. We strive to build a tightly knit, supportive and collaborative environment where our team members can thrive and make meaningful contributions to human health.

About the Role:

The Clinical Operations Manager 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 RESPONSIBILITIESinclude the following. Other duties may be assigned.

• Comply with all company policies, procedures and conduct.
• Strictly adhere to confidentiality and compliance standards.
• 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 ACN quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs.
• 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.
• Oversee SIV, PSDV and IMV.
• Manage and facilitate study startup documentation, training, supplies and timelines of study protocols.
• 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.
• Other tasks as assigned.

QUALIFICATION REQUIREMENTS: The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE:

• Bachelor's degree preferred in healthcare or equivalent clinical research experience.
• 5+ years of clinical management experience or equivalent applicable experience in clinical research industry
• 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.