Clinical Operations Manager

Be Well Clinical Studies•Round Rock, TX

11d•Onsite

About The Position

The Clinical Operations Manager (COM) at Be Well Clinical Studies plays a pivotal role in supporting, facilitating, and coordinating daily trial activities. The COM ensures the smooth and efficient management of clinical trials by overseeing data collection, adherence to protocols, and maintaining communication with study participants and staff. This role involves project management, staff leadership, and ensuring that all aspects of the trial process comply with regulatory standards and company SOPs.

Requirements

Minimum of a High School Diploma with relevant experience. BA/BS preferred.
5 years Clinical Research Experience

Nice To Haves

Personnel management and leadership.
Project management experience.
Strong medical and scientific knowledge.
Analytical skills to collect, interpret, and present data effectively.
Excellent written, communication, and interpersonal skills.
Problem-solving abilities with a focus on efficiency and organization.
Strong organizational skills to handle study initiation, execution, and adherence to research guidelines.

Responsibilities

Oversee the smooth operation of clinical trials, troubleshooting and mitigating issues as needed.
Enforce Be Well Clinical Studies' Standard Operating Procedures (SOPs) and ensure compliance with protocols.
Perform study visits and manage day-to-day study activities.
Lead, coordinate, and manage clinical teams by setting an example.
Collect, code, and analyze research data.
Manage trial budgets and departmental resources efficiently.
Communicate study objectives with participants and ensure adherence to study rules.
Administer questionnaires, monitor participant progress, and handle participant follow-up.
Liaise with physicians, laboratories, and external parties regarding research findings and trial progress.
Ensure trials are conducted ethically and comply with regulatory standards.
Maintain detailed research records, including case report forms, drug dispensation logs, and regulatory forms in compliance with FDA guidelines.
Oversee the collection, labeling, storage, and transport of specimens.
Ensure the availability and functionality of study-related equipment and supplies.
Conduct patient visits, process lab draws, ship specimens, dispense drugs, and vaccinate patients.
Record and maintain accurate data within eSource and eReg systems.
Meet regularly with study monitors to review study progress and resolve issues.
Foster a positive team culture where staff can thrive and grow.
Ensure appropriate staffing and schedule coverage.
Manage facility maintenance and organization.
Oversee staff time clock management, assignments, and training.
Coordinate investigator availability for study needs.