Alcanza Clinical Research

Inclusive clinical trials for diverse patients

Clinical Operations Manager

Clinical Research OperationsUpdated on Nov 13

Full-timeDecatur, GA, USANo salary listed

About the Job

Requirements

A bachelor's degree and at least 2 years of clinical research experience, or an equivalent combination of education and experience, are required.
At least 2 years of experience as a clinical research coordinator (CRC) are required.
Proficiency with computer applications, including Microsoft applications, email, electronic health records, and web applications, and proficient typing at 40 or more words per minute are required.
Strong organizational, time-management, problem-solving, and project-management skills to meet project deadlines are required.
Well-developed written and verbal communication skills are required.
Well-developed interpersonal and listening skills, and the ability to work independently and with coworkers, subjects, managers, and external customers are required.
The ability to handle multiple tasks and adapt to changing workloads and priorities is required.
The ability to work with minimal supervision, identify problems, and implement solutions is required.
The ability to handle sensitive information confidentially and professionally, in compliance with HIPAA guidelines, is required.

Responsibilities

Lead the operational performance of clinical research staff and provide on-site oversight to ensure clinical research activities are executed and coordinated according to ICH guidelines, good clinical practice (GCP), FDA guidelines, and company policies and procedures.
Manage and support the team, focusing on study performance, efficiency, patient safety, and protocol, GCP, and regulatory compliance.
Collaborate with Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality to coordinate delivery expectations, meet study milestones such as site activation and enrollment targets, meet 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 data reflects timely execution of required visits and calls, including their duration and frequency.
Oversee resource allocations, site assignments, and study-team output and performance; ensure deliverables remain on track, identify delivery or quality risks, and escalate risks related to timelines, quality, and budgets.
Assist with initial and ongoing training on protocol specifics, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and study timelines.
Ensure adherence to SOPs, GCP, FDA regulations, and company policies and procedures.
Oversee assigned site staff and routinely assess study-specific processes, training compliance, and CMP compliance; identify emerging risks and develop and support corrective action plans at site and study level as needed.
Oversee people-management activities, including timecards, absence tracking and approvals, new-hire training, interviewing and selection, performance appraisals, job-description preparation, employee counseling, career coaching, and employment meetings.
Manage assigned site staff, proactively identify and resolve issues, and support successful site operations.
Collaborate with investigators to ensure patient safety and meet client goals and timelines.
Use 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

At least 1 year of management experience in clinical research is highly preferred.
Bilingual English and 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 Manager, Clinical Operations is responsible for leading the operational performance of the clinical research staff. Provides on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, FDA guidelines and follows company policies and procedures.

Essential Job Duties:

Overall team management and leadership support with a focus on driving study performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance.
Collaborating with other departments (Business Development, Patient Recruitment, Finance, Budgets and 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. 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 employment meetings.
Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations.
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:

Bachelor’s degree and a minimum of 2 years of clinical research experience, or an equivalent combination of education and experience, is required. 2+ years’ experience as a clinical research coordinator (CRC) is required. 1+ years of management experience in clinical research 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, 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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