Clinical Site Director: Research Operations & Compliance

Alcanza Clinical Research, LLC; Gilbert (AZ); On-site; USD 70,000 - 110,000; Full time

Job summary

Alcanza Clinical Research, LLC in Phoenix Medical Trials - Gilbert, AZ is seeking a Clinical Site Manager to oversee site activities. This role focuses on driving site performance, patient safety, protocol/GCP/regulatory compliance, and on-site coordination with sponsors and investigators.

The ideal candidate has an Associate’s degree with 3+ years in clinical research and at least one year of people management experience.

Qualifications

• Associate’s degree and 3+ years of clinical research experience required.
• One or more years of management experience preferred.
• Bi-lingual English/Spanish is a plus.

Responsibilities

• Overall site management and leadership with a focus on driving site performance, patient safety and protocol/GCP/regulatory compliance.
• Collaborating with manager to support delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and delivery quality data to sponsors.
• 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).
• 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).
• 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;
• Overseeing people management activities including timecards, absence tracking/approvals, new hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and termination meetings.
• Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations;
• 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;
• Collaborating with investigators to ensure patient safety and meeting client goals and timelines;
• Employing 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.

Skills

Clinical research

Management

Bilingual English/Spanish

Education

Associate’s degree

Job description

Alcanza Clinical Research, LLC in Phoenix Medical Trials - Gilbert, AZ is seeking a Clinical Site Manager to oversee site activities. This role focuses on driving site performance, patient safety, protocol/GCP/regulatory compliance, and on-site coordination with sponsors and investigators.

The ideal candidate has an Associate’s degree with 3+ years in clinical research and at least one year of people management experience.