Alcanza Clinical Research

Inclusive clinical trials for diverse patients

Clinical Site Director

Clinical Research OperationsUpdated on Nov 13

Full-timeDecatur, GA, USANo salary listedIn-person

About the Job

Requirements

A Bachelor's degree and at least 5 years of clinical research experience, or an equivalent combination of education and experience, are required.
At least 2 years of clinical research site management experience are required.
Proficiency with Microsoft applications, email, electronic health records, and web applications, with typing proficiency of at least 40 words per minute, is required.
Strong organizational, time management, problem-solving, and project management skills are required to meet project deadlines.
Well-developed written and verbal communication skills are required.
Well-developed interpersonal and listening skills, and the ability to work independently and effectively with coworkers, subjects, managers, and external customers, are required.
The ability to handle multiple tasks effectively and adapt to changes in workloads and priorities is required.
Professionalism, respect for others, self-motivation, a strong work ethic, integrity, and dependability are required.
The ability to work under minimal supervision, identify problems, and implement solutions is required.
The ability to handle highly sensitive information confidentially and professionally, in compliance with HIPAA guidelines, is required.

Responsibilities

Drive operational performance at the research site and provide on-site oversight to ensure clinical research activities are executed and coordinated according to ICH, GCP, and FDA guidelines and company policies and procedures.
Manage the site overall, focusing on site performance, efficiency, patient safety, and protocol, GCP, and regulatory compliance.
Collaborate with Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality leaders to coordinate delivery expectations, meet study milestones and budgets, and deliver quality data to sponsors.
Review performance dashboards and clinical trial systems to oversee site and patient activities, ensure appropriate staff coverage, and ensure timely updates reflecting operational execution, including required visits and calls, duration, and frequency.
Oversee resource allocations, site assignments, and study team members' output and performance to keep deliverables on track; identify risks to delivery or quality and escalate risks affecting timelines, quality, or budgets.
Assist with initial and ongoing training on protocol-specific requirements, Case Report Form completion, Standard Operating Procedures, clinical plans and guidelines, and study timelines.
Ensure adherence to standard operating procedures, good clinical practice, FDA regulations, and company policies and procedures.
Oversee assigned site staff and routinely assess study-specific process and training compliance, CMP compliance, and emerging risks.
Develop and support corrective action plans at the site and study levels.
Oversee people-management activities, including interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching, and termination meetings; manage site staff, proactively identify and resolve issues, and support successful site operations.
Oversee payroll, absence tracking and approvals, new-hire orientation, and training according to operational needs.
Collaborate with investigators to ensure patient safety and meet client goals and timelines.
Apply strategic thinking and 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

Bilingual proficiency in English and Spanish.

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 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.

Essential Job Duties:

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.

Minimum Qualifications: A Bachelor’s degree AND 5+ years of clinical research experience or an equivalent combination of education and experience is required. 2+ years of clinical research site management experience is required. Bi-lingual (English / Spanish) proficiency is preferred.

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, 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.

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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