Clinical Research Site Manager

About the role

The Clinical Site Manager oversees the performance of clinical research activities at the research site. This position ensures that all activities comply with ICH/FDA guidelines, GCP, and company SOPs, policies, and procedures.

Responsibilities

• Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, patient safety, and protocol/GCP/regulatory compliance;
• Collaborating with manager to support delivery expectations, meet expected study milestones, meet budgets, and deliver 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 reflects 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 identifying emerging risks. May develop and support execution of corrective action plans at site and study level;
• Managing assigned site staff, proactively identifying and resolving issues, and working to ensure successful site operations;
• Aiding with initial and ongoing trainings regarding protocol specifics, 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;
• Performing all other duties as required or assigned.

Requirements

• An Associate’s degree and a minimum of 3 years of clinical research experience, or an equivalent combination of education and experience, is required.
• One or more years of management experience is highly preferred.
• Bi-lingual (English / Spanish) proficiency is a plus.

Skills, Knowledge And Expertise

• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
• Strong organizational, time management, and problem solving skills.
• 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.
• Professionalism, respect for others, self-motivation, and a strong work ethic.
• 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.

Benefits

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.