Associate Director of Clinical Operations

This position is responsible for the comprehensive operational and relationship management of clinical trial activities associated with a key Javara healthcare partnership.

Position Type

This is a full-time, exempt position.

Essential Job Responsibilities

With a guiding principle of research participant safety, the Associate Director of Clinical Operations is responsible for promoting the mission of Javara and ensuring that the strategic integrity of the relationship between Javara and the healthcare organization is upheld. The Associate Director of Clinical Operations is responsible for impeccable trial execution, and consistent data integrity to ensure that ongoing trust and confidence is maintained in the clinical trials conducted within the healthcare organization. The Associate Director of Clinical Operations is a specialized research professional responsible for the expansion of clinical research across the healthcare organization’s network in the State of Georgia, and the management of clinical trial operations at various clinical research sites within the region. The Associate Director of Clinical Operations is responsible for the strategic planning, administration, and operation of all clinical research activities conducted by Javara within the healthcare organization. It is anticipated that therapeutic areas of research will be multi-specialty; inpatient, outpatient and oncology trials.

Specific Responsibilities

  • 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 Environment

This job operates in a professional environment. This role routinely uses standard office equipment such as computers, laptops, phones, tablets, photocopiers, and printers.

Travel Requirements

This 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 Duties

Please 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.

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