The Las Olas Network has been engaged by an organization in the Clinical Research space that is looking to hire a new Clinical Site Director to oversee 2 dedicated clinical trial sites in the Houston area.
The role will be responsible for driving operational performance of the research sites, as well as providing on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, FDA guidelines and follows company policies and procedures.
The key functions of this Clinical Site Director role will include the following -
- Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance;
- Collaborating with departments leaders in Business Development, Patient Recruitment, Finance, Budgets and Contracts and Quality to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and delivery quality data to sponsors
- Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency)
- Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, identifying risks to delivery or quality, and escalating any risks to clinical trial management deliverables (timeline, quality and budget)
- Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study
- Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures;
- Overseeing site staff assigned to the study and routinely assessing study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level
The ideal candidate will be a mission driven leader who is passionate about high performing teams and has a desire to gain further understanding of the business to drive performance.
Minimum Qualifications: A Bachelor’s degree AND 8+ years of clinical research experience AND 5+ years of management experience, or an equivalent combination of education and experience is required. Clinical research site management experience highly preferred. Bi-lingual (English/Spanish) proficiency is preferred.
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
- Must possess strong organizational, time management, problem solving, and project management skills to meet project deadlines.
- Well-developed written and verbal communication skills.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
- Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
