Clinical Operations Manager-Traveling CRC Team

Alcanza Clinical Research•Lake Mary, FL

13d

About The Position

The Manager, Clinical Operations – Traveling Team coordinates and executes clinical research support at various site locations. The role manages and supports a high-performing traveling team to enhance efficiency, ensure patient safety and protocol/GCP/regulatory compliance, and meet operational targets. The manager works with leaders across Study Delivery, Operations, Strategy, and Training to coordinate study delivery, resourcing, site assignments, team performance, study milestones, and quality data for sponsors. The position also oversees staff training and people-management activities and may perform clinical research coordinator duties under the direction of the Site Director and Principal/Sub Investigators. Up to 100% travel is stated as required; the qualifications section separately notes travel up to 50%, as needed.

Requirements

Associate degree and at least 3 years of clinical research experience, or an equivalent combination of education and experience.
At least 1 year of management experience.
Proficiency with Microsoft applications, email, electronic health records, and web applications; typing proficiency of 40+ words per minute.
Strong project management and organizational skills.
Ability to manage multiple priorities and timelines.
Excellent communication and stakeholder-management skills.
Strong problem-solving and risk-mitigation abilities.
Attention to detail and well-developed written and verbal communication skills.
Professional, respectful, self-motivated, dependable, and strong work ethic.
Ability to work with minimal supervision, identify problems, and implement solutions.
Ability to handle sensitive information confidentially and professionally in compliance with HIPAA guidelines.
Willingness to travel; the description states up to 100% travel required and separately lists travel up to 50%, as needed.

Nice To Haves

Bilingual English/Spanish proficiency.

Responsibilities

Manage and support the traveling team and assigned site staff, fostering efficiency, patient safety, compliance, and achievement of targets.
Collaborate with department leaders to coordinate delivery expectations and meet study milestones, including site activation and enrollment targets, while delivering quality data to sponsors.
Oversee resource allocations, site assignments, team output, and performance; identify and escalate risks to timelines, quality, and budget.
Work with management to support site performance goals, proactively resolve issues, meet study milestones, and ensure data quality.
Provide initial and ongoing staff training on clinical systems, protocols, CRF completion, SOPs, GCP, IATA, and clinical plans and guidelines.
Assess staff work outcomes, performance, and compliance.
Oversee people-management activities, including interviewing and selection, performance appraisals, counseling, career coaching, and performance meetings.
Manage staff timecards and pay, absence tracking and approvals, new-hire orientation, and training according to operational needs.
Under the direction of the Site Director and Principal/Sub Investigators, screen patients, obtain consents, conduct follow-up visits, and document information in source clinic charts.
Enter data in EDC and answer queries; obtain vital signs and ECGs; perform basic protocol-required laboratory procedures when applicable, including specimen collection, centrifuging, storage, shipping, accountability, and courier coordination.
Request and track medical records; update and maintain logs and chart files; maintain and order study supplies; schedule study visits and send appointment reminders; and build or update source documents as needed.
Conduct monitoring visits and resolve issues in a timely manner.
Ensure investigators review study reports and patient results promptly; file SAE and deviation reports with sponsors and IRBs as needed; document and report adverse events; and report non-compliance promptly.
Complete individual and team study start-up activities, including required training and filing certificates in the ISF.
Ensure adherence to SOPs, GCP, FDA regulations, and company policies and procedures.
Collaborate with investigators, site teams, and support teams to meet goals and timelines; identify problems and implement risk mitigations.
Participate in and, at times, present at management, production, and site meetings.
Perform other duties as required or assigned.