Lead Travel Clinical Research Coordinator

Position Summary

CTNx is seeking an experienced and highly motivated Travel Clinical Research Coordinator (CRC) to support an expanding clinical research program. This role is ideal for a research professional who enjoys working directly with patients, physicians, and study sponsors while helping build and support research operations across multiple clinical sites.

The Travel CRC will serve as the primary coordinator for assigned clinical trials and will be responsible for participant recruitment, study execution, regulatory compliance, source documentation, data collection, and sponsor communication. This individual will travel regularly to research locations, initial primary location being Sandusky, and other Ohio-based sites as research operations continue to expand (Lyndhurst, Lorain, etc).

The successful candidate will be highly organized, adaptable, self-motivated, and capable of working independently while maintaining the highest standards of patient care, data quality, and regulatory compliance.

Essential Duties and Responsibilities

Clinical Trial Management

• Coordinate and manage clinical trials from study start-up through closeout.
• Serve as the primary liaison between Principal Investigators, study sponsors, CROs, and CTNx leadership.
• Ensure strict adherence to study protocols, sponsor requirements, and regulatory guidelines.
• Track study milestones, enrollment goals, participant visits, and study deliverables.
• Identify, document, and communicate protocol deviations and corrective actions.
• Support monitoring visits, audits, and sponsor inspections.
• Ensure participant safety through ongoing oversight and adverse event management.

Patient Recruitment and Retention

• Identify and screen potential research participants according to protocol-defined inclusion and exclusion criteria.
• Conduct informed consent discussions and ensure participants fully understand study requirements, risks, and benefits.
• Develop and implement recruitment and retention strategies to meet enrollment goals.
• Maintain consistent communication with study participants throughout the duration of the trial.
• Coordinate participant scheduling and follow-up activities.
• Address participant concerns and provide exceptional patient support.

Data Collection and Documentation

• Maintain accurate, complete, and timely source documentation utilizing CRIO and sponsor-required systems.
• Enter study data and resolve data queries within established timelines.
• Document and report adverse events, serious adverse events, and protocol deviations.
• Maintain audit-ready study files and essential regulatory documentation.
• Ensure participant confidentiality and compliance with HIPAA requirements.
• Support source document review and quality assurance activities.

Regulatory and Compliance Responsibilities

• Maintain compliance with FDA regulations, ICH-GCP guidelines, sponsor requirements, and institutional policies.
• Assist with preparation and submission of regulatory documentation to Institutional Review Boards (IRBs).
• Ensure informed consent processes are conducted and documented appropriately.
• Support regulatory inspections, sponsor audits, and internal quality reviews.
• Maintain accurate delegation logs, training records, and study-specific documentation.
• Ensure all research activities are conducted ethically and in accordance with applicable regulations.

Site Support and Travel Responsibilities

• Travel regularly to research locations throughout northeast Ohio.
• Provide on-site research coordination support during study start-up, enrollment, monitoring visits, and closeout activities.
• Collaborate with physicians, practice staff, and CTNx operational teams to ensure successful study execution.
• Assist in establishing and maintaining research workflows across multiple locations.
• Support future site expansion initiatives as additional research locations are activated.
• Backup coordination for CTNx clients as necessary

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this position. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

Required Qualifications

• Bachelor's Degree in Life Sciences, Healthcare Administration, Nursing, Public Health, or related field.
• Minimum of three (3) years of Clinical Research Coordinator experience.
• Demonstrated experience coordinating industry-sponsored clinical trials.
• Working knowledge of FDA regulations, ICH-GCP guidelines, and IRB processes.
• Experience with electronic data capture systems and source documentation practices.
• Strong organizational, communication, and problem-solving skills.
• Ability to work independently in a fast-paced environment.
• Valid driver's license and reliable transportation.

Preferred Qualifications

• ACRP Certification (CCRC) and/or SOCRA Certification (CCRP).
• Two (2) years as Lead/Senior Clinical Research Coordinator experience.
• Experience working across multiple therapeutic areas.
• Experience utilizing CRIO or similar clinical research source management platforms.
• Experience supporting multi-site clinical research programs.
• Previous experience working with physician-owned research sites.

Physical Requirements

• Ability to travel frequently
• Ability to sit, stand, and walk for extended periods.
• Ability to transport research materials and equipment when necessary.
• Ability to work on-site in clinical environments.

What We Offer

• Competitive salary and performance-driven environment.
• Opportunity to work alongside leading physicians and research professionals.
• Exposure to diverse therapeutic areas and clinical trials.
• Career growth opportunities within a rapidly expanding clinical research network.
• Meaningful impact on advancing clinical research and improving patient care.

CTNx is an Equal Opportunity Employer and is committed to fostering a diverse and inclusive workplace.