- Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, pati,ent safety and protocol/GCP/regulatory compliance.
- Collaborating with department leaders in Business Development, Patient Recruitment, Finance, and Budgets 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.
- Develop and support execution of corrective action plans at site and study level.
- Overseeing people management activities including interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and termination meetings. Managing site staff, proactively identify and resolve issues, and work to ensure successful site operations.
- Overseeing all payroll, absence tracking/approvals, new hire orientation, and training per operational needs.
- Collaborating with investigators to ensure patient safety and meeting client goals and timelines.
- Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Participating and presenting in management or site meetings.
- Perform all other duties as required or assigned.
- 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.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
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Clinical Research Site Director - DeLand, United States - Alcanza Clinical Research
Description
Clinical Research Site DirectorDepartment: Operations
Employment Type: Full Time
Location: Accel Research Sites - DeLand, FL
Description
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Clinical Site Director is responsible for driving operational performance for of the research site. Provides on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, and FDA guidelines and follows company policies and procedures.
Key Responsibilities
A Bachelor's degree and a minimum of 8 years of clinical research experience, or an equivalent combination of education and experience, is required. 5+ or more years of management experience is required. Clinical research site management experience is required. Bi-lingual (English / Spanish) proficiency is preferred.
Required Skills:
