- Promoting the mission of Javara with a primary guiding principle of research participant safety, research participant well-being, and doing so with integrity and excellence to those we serve.
- Managing and developing an effective clinical trial team including hiring, training, mentoring, coaching, corrective action and evaluating.
- Ensuring the strategic goals and objectives set forth between Javara and the healthcare organization are attained.
- Complying with the terms outlined in the Integrated Research Agreement between the healthcare organization and Javara.
- Ensuring that quality measures are being obtained, and population health initiatives are being followed.
- Cultivating relationships with new prospective clinical research providers within the healthcare organization and providing high quality customer support to build credibility and trust.
- Establishing and maintaining strong long-term relationships with the healthcare organization and identifying, developing, and implementing marketing and outreach plans, presentations and strategies designed to grow the partnership between the healthcare organization and Javara.
- Managing the allocation, sharing and efficient utilization of clinical trial resources to achieve performance objectives, while ensuring quality and consistency.
- Ensuring clinical trial team safety, regulatory compliance, and that Javara’s standard operating procedures and guidelines are followed, as well as ensuring that all team members comply with all FDA, ICH/GCP Guidelines and state and local laws and regulations.
- Overseeing uniform application of clinical trial technology systems, policies, and procedures.
- Assisting with identifying types of clinical trials that will align with population health strategies and financial objectives of the healthcare organization.
- Overseeing and/or conducting pre-qualification visits, site initiations and study closeouts with sponsor representatives, including proactive engagement for feedback regarding site performance.
- Assisting with development of an operating budget for clinical trial operations within the healthcare organization as well as budgets associated with clinical trials.
- Assisting and/or developing programs and processes that maximize research participant identification, enrollment, retention, and ongoing engagement, including training and accessing EMR to assess viability of enrolling in trials
- Assisting with onboarding of new technology when appropriate.
- Assisting with additional responsibilities as determined by Javara leadership.
Work EnvironmentThis job operates in a professional environment. This role routinely uses standard office equipment such as computers, laptops, phones, tablets, photocopiers, and printers.
Travel RequirementsThis position may involve 25-40% travel with most of the travel within the State of Georgia. This position may require air travel to meetings and may require frequent visits to the Javara headquarters in Winston-Salem, NC.
Required Education or Experience
- BS/BA in Life Science or related discipline preferred
- Requires minimum of 3 years’ experience managing a clinical research site/team or related management experience
- At least 4 years prior experience in clinical trial research preferred
- Understanding of clinical trial processes, FDA regulations and ICH/GCP Guidelines
- Able to use standard office software, as well as proprietary applications unique to the clinical trial industry
- Experience with project management and handling multiple tasks concurrently; meeting concurrent deadlines, while maintaining focus in a fast-paced environment
Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Javara is an integrated research organization (IRO) that advances value by integrating clinical research within the healthcare ecosystem. Javara brings better outcomes for patient centered care, better economic results, improved access to cutting edge therapies and a more predictable research delivery model to the biopharmaceutical sector.
EOE Statement: We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.