Alcanza Clinical Research

Inclusive clinical trials for diverse patients

Clinical Site Manager

Clinical Research OperationsUpdated on Nov 13

Full-timeGilbert, AZ, USANo salary listed

About the Job

Requirements

An Associate’s degree and at least 3 years of clinical research experience, or an equivalent combination of education and experience, is required.
Proficiency with Microsoft applications, email, electronic health records, and web applications, with typing proficiency of 40+ words per minute.
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 independently and with coworkers, subjects, managers, and external customers.
Ability to handle multiple tasks and adapt to changes in workloads and priorities.
Professional conduct, respect for others, self-motivation, a strong work ethic, integrity, and dependability.
Ability to work under minimal supervision, identify problems, and implement solutions.
Ability to handle highly sensitive information confidentially and professionally, in compliance with HIPAA guidelines.

Responsibilities

Oversee performance of research site activities, providing on-site oversight to support execution and coordination of clinical research visits, documentation, and follow-up actions according to ICH/FDA guidelines, GCP, and company SOPs, policies, and procedures.
Manage site operations and lead site activities to drive performance, enhance efficiencies, support patient safety, and maintain protocol, GCP, and regulatory compliance.
Collaborate with the manager to meet delivery expectations, study milestones, budgets, and data-quality expectations for sponsors.
Oversee resource allocations, site assignments, study-team output and performance; ensure study deliverables remain on track; identify and escalate risks to timelines, quality, and budget.
Review performance dashboards and clinical trial systems to oversee site and patient activities, ensure staff coverage, and keep operational activity data current, including required visits and calls, duration, and frequency.
Ensure adherence to standard operating procedures, good clinical practice, FDA regulations, and company policies and procedures.
Oversee study-assigned site staff and assess study-specific processes, training compliance, and CMP compliance; identify emerging risks and develop or support corrective action plans at the site and study levels.
Manage people activities, including timecards, absence tracking and approvals, new-hire training, interviewing and selection, performance appraisals, job-description preparation, employee counseling, career coaching, and termination meetings.
Manage assigned site staff, proactively identify and resolve issues, and support successful site operations.
Assist with initial and ongoing training on protocol specifics, Case Report Form completion, Standard Operating Procedures, clinical plans and guidelines, and study timelines.
Collaborate with investigators to support patient safety and meet client goals and timelines.
Use problem-solving to propose and implement risk mitigations.
Participate in and present at management or site meetings.
Perform other duties as required or assigned.

Desired Qualifications

One or more years of management experience is highly preferred.
Bilingual English/Spanish proficiency is a plus.

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, 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 Manager is responsible for overseeing performance of the research site activities. Provides on-site oversight to help ensure execution and coordination of clinical research activities visits, documentation and follow up actions according to ICH/FDA guidelines, GCP, and company SOPs, policies and procedures.

Essential Job Duties:

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 (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.

Minimum Qualifications: 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.

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 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.
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.

About the Company

Alcanza Clinical Research

Inclusive clinical trials for diverse patients

Alcanza Clinical Research conducts inclusive clinical trials by partnering with pharmaceutical companies, medical providers, and community organizations to enroll diverse patient populations across major therapeutic areas. Its studies follow established protocols with certified research professionals to ensure patient safety and data integrity, while participants may receive health tests and access to emerging treatments at no cost. The company differentiates itself through active community collaboration, broad patient diversity, and education alongside trial execution, expanding trial reach. Its goal is to speed the development of new therapies by removing participation barriers and delivering high-quality, diverse clinical research.

Company size: 201-500
Company stage: Not listed
Total funding: Not listed
Headquarters: Lake Mary, FL
Founded: 2021

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