Manager of Clinical Research Operations

Job Description

Job Description

Job Description
As the Manager, Site Operations, you will be responsible for comprehensive operational and relationship management of clinical trial activities associated with our healthcare partnerships. With a guiding principle of research participant safety, you will promote the mission, vision, and values of Javara and ensure the strategic integrity of the relationship between our teams and the healthcare organization. You will demonstrate leadership capabilities and consistently demonstrate high-quality and results-oriented performance. You will be on-site daily and report to the regional Director, Site Operations and lead clinical teams across multiple locations with multiple therapeutic areas of research with multi-specialty, inpatient and outpatient trials.

Essential Responsibilities:

• Promote a culture that ensures patient safety above all and improves the patient experience in everything we do.
• Drive accountability for patient enrollment, ensuring Clinical Trial Navigators own the enrollment plan to meet recruitment goals for their specific studies.
• Ensure the highest standard of integrity, quality, and operational excellence in clinical research activities, with adherence to Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA, Integrated Research Agreements (IRAs), and other applicable federal, state, and local regulations.
• Positively impact engagement, retention, and the employee experience by demonstrating the core behaviors for people managers in three key pillars: Engage & Inspire, Drive Success, and Empower & Develop.
• Recruit, train, manage, and coach Site Operations team members and ensure they meet expectations in accordance with role expectations and company goals.
• Maintain a staffing plan for resourcing and utilization of site operations team members for multiple locations or larger sites to achieve performance objectives, identify opportunities or gaps, and implement plans accordingly.
• Oversee the standardized utilization of systems, data entry, and clinical trial operations best practices.
• Cultivate, maintain, and develop strong long-term relationships with investigators and practice staff and provide insight on the best clinical trials for their patient population.
• Maximize research participant identification, enrollment, retention, and ongoing engagement by developing programs and processes, including training and accessing EMR to assess viability of enrolling in trials.
• May manage multiple sites or satellite site locations.
• Provide high quality client support to build credibility and trust while meeting the needs and strategic objectives of healthcare partners, sponsors, CROs, patients, vendors, and colleagues.
• Manage study and site performance including developing and adhering to an operating budget for clinical trial operations within the healthcare organization as well as budgets associated with clinical trials.
• Other responsibilities as assigned.

Qualifications:

• 2+ years’ experience managing a clinical research site and team or equivalent relevant management experience.
• 5+ years’ of clinical trial research experience including hands-on application of clinical functions such as obtaining vitals, EKG’s, and phlebotomy.
• Associates or Bachelors Degree or equivalent educational experience. Degree in Life Sciences or related field highly beneficial.
• Experience applying leadership approaches such as situational leadership, servant leadership, and transformational leadership for people management.
• Experience using business acumen to develop strategies to achieve and exceed expected results.
• Project Management

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• This job operates in a professional environment.
• The noise level in this work environment is usually light to moderate.

Physical Demands:

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

• The employee will regularly use hands to reach, handle or feel objects, tools, or controls and talk and hear.
• The employee may frequently stand, walk and sit.
• The employee may occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required include close vision, distance vision and the ability to adjust focus.

Travel: This position may involve up to 20% travel with most travel within their region, as well as applicable visits to Javara headquarters in Winston Salem, NC.

Pre-Employment Screening: Drug screen and background check required.