Director of Site Operations-Clinical Research

Professional Case Management•Atlanta, GA

20h

About The Position

The Director Site Operations will have line management responsibility for the personnel at the sites assigned to them ensuring the clinical conduct at the site is being performed according to protocol requirements, local regulations and as delegated by the site principal investigator. This position will employ skills in community-based research and develop innovative site solutions that reach and operate in the heart of the community, supporting our commitment to diversity and inclusion in research, through analysis, experience and strategic solutioning. As Site Director you will promote a healthy, collaborative, and open culture environment at our sites as well as with the larger company.

Requirements

Bachelor’s degree in health research, public health, or science or a related field
Five or more years of experience in the clinical research industry or equivalent.
3 or more years supervising a team
Excellent communication skills, demonstrated effective spoken and written communication, including willingness to ask questions when clarification or amplification is required
Ability to cascade initiatives to site teams and ensure adaptation as well as success of the initiative.
Demonstrated attention to detail and ability to adhere to instructions/procedures
Good time management skills; efficient and resourceful in problem-solving
Demonstrated ability to take ownership of the work, possess initiative, good follow-through; ability to work without supervision.
Ability to receive and benefit from feedback; willingness to expand skill set and improve
Flexibility in adapting to new procedures and environments
Ability to work in a team environment
Familiarity with research/data collection software

Responsibilities

Champion and take pride in your assigned research sites and communities internally and externally.
Invest time in your site teams to hire and build a healthy, compliant, high-performance culture.
Ensure sites are resourced with appropriated trained, experienced and licensed staff to enable trial conduct.
In collaboration with other Site Directors, ensure adequate back-up and cross licensed staffing to provide coverage for absence, securing the ability to deliver projects.
Maintain relationships with leaseholders to ensure effective collaboration and security of community site locations.
Ensure your site teams set clear personal and business goals, conducting reviews to foster a culture of collaboration, continuous improvement, and personal development.
Capacity management of research site, collaborating cross functionally with leadership, sales, and fleet.
Ensure patient experience and community engagement is at the heart of your research site teams.
Train and mentor, your research staff and teams.
Hold regular cross-site briefings to share experience, lessons learned and update on targets.
Attend Site tours, PSVs, SIVs, COV’s and where applicable, monitoring visits.
Conduct site visits and reviews to support, coach, and evaluate needs.
Attend site audits and inspections.
Ensure effective collaboration between your research teams, the Principal Investigator, Patient Engagement, Regulatory, Project Management and Fleet teams to delivery compliant and coordinated community research whilst mitigating risk.
Provide support to QA in all facets of work related to communications with and management of the site clinical teams.
Perform site self-audits and monitor performance and productivity of assigned sites.
Support your sites in the attraction, consenting, and retention of clinical trial participants.
Act as a primary point of contact for Project Managers for matters pertaining to your site.
Manage and develop CRCs to ensure they provide effective protocol training, system training, and study specific support to the research sites.
Collaborate with patient recruitment to ensure project timelines are met and offer support as needed.
Monitor study randomization plans, patient retention, data completion, and overall compliance; take corrective action where appropriate – often by cross functional collaboration.
Address CAPAs in an open and expediated fashion.
Monitor study inventory usage and approve resupply requests.
Be in open communication with Project Management team to solve for how client supply chain management and decision-making impacts delivery at sites.
Customer point of escalation, per study communication plan.
Will serve as liaison between project stakeholders and leadership and maintain professional documentation for projects and deliverables.
Stay current with constantly changing clinical research technology and embrace innovation.
Accountable for assigned research site P&L.
Forecast monthly enrollment goals, in collaboration with Project Management.
Monitor performance on a daily and weekly basis to ensure monthly targets are achieved.
Forecast site resource needs and set staffing models to achieve customer delivery.