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Alcanza Clinical Research · 6 hours ago

Clinical Research Site Director

Farmington Hills, MI

Full-time

Onsite

Senior Level

5+ years exp

Alcanza Clinical Research is a growing multi-site, multi-phase clinical research company with a strong presence across various therapeutic areas. The Clinical Site Director is responsible for driving operational performance at the research site, ensuring compliance with clinical guidelines, and overseeing site management and staff performance.

Clinical TrialsHealth CareMedical

Responsibilities

Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, patient 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

Qualification

Clinical research experienceSite management experienceGCP complianceBilingual (English/Spanish)Project management skillsProblem-solving skillsOrganizational skillsCommunication skillsInterpersonal skillsTime management skills

Required

A Bachelor's degree AND 5+ years of clinical research experience or an equivalent combination of education and experience is required

2+ years of management experience required

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