Position
The Clinical Research Associate (CRA) will support the planning, start-up, execution, oversight, and closeout of assigned clinical studies. The CRA serves as an operational link among investigational sites, CRO and field-monitoring personnel, vendors, and internal study-team members. The role helps ensure participant protection, reliable study data, timely site execution, and inspection-ready documentation in accordance with the protocol, Ocugen procedures, ICH Good Clinical Practice (GCP), and applicable regulatory requirements.
Responsibilities
- Support the start-up, execution, maintenance, and closeout of assigned Phase 1–3 clinical trials.
- Coordinate site identification, feasibility, qualification, activation, essential-document collection, and closeout activities.
- Serve as an operational contact for investigational sites, supporting enrollment, data entry, query resolution, safety follow-up, and timely completion of study activities.
- Oversee and partner with CRO and field CRAs to support training, monitoring-plan execution, quality monitoring reports, and closure of findings and action items.
- Review site performance, monitoring reports, protocol deviations, and study metrics to identify and escalate risks affecting timelines, participant safety, or data quality.
- Maintain accurate CTMS, eTMF, study trackers, site metrics, and action and decision logs to support inspection readiness.
- Coordinate investigational product and study-sample tracking, including shipment, receipt, accountability, return, destruction, and supporting documentation.
- Review and maintain informed consent forms, essential documents, study plans, monitoring guidelines, site materials, templates, and training materials.
- Coordinate with internal functions, CROs, sites, and vendors to achieve study deliverables.
- Support audit and regulatory-inspection readiness, budget and invoice tracking, process improvements, and development of Clinical Operations procedures and tools.
- Perform other duties and projects consistent with the position and business needs.
- Canada-based position with the work arrangement designated by Ocugen and stated in the applicable offer or employment documentation.
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline, or an equivalent combination of education and relevant experience.
- At least three years of hands-on clinical research experience within a biotechnology, pharmaceutical, or CRO environment.
- Sponsor-side study-management or independent clinical-site monitoring experience strongly preferred.
- Working knowledge of ICH E6(R3) GCP, applicable Health Canada requirements, research ethics requirements, and other regulations governing clinical trials. Familiarity with U.S. FDA requirements is preferred.
- Experience with eTMF, CTMS, and EDC systems; Veeva experience is preferred.
- Experience with ophthalmology, gene therapy or other advanced therapies, and Phase 1–3 studies is preferred.
- Strong judgment, organization, communication, collaboration, and problem-solving skills, with the ability to identify risks, manage competing priorities, and work independently.
Working Conditions
- Travel of up to approximately 20% may be required for investigational-site, vendor, CRO, investigator, team, audit, or inspection-related activities. Travel requirements may vary by study needs.
- The role may occasionally require availability outside normal business hours to support priority study needs or collaboration across time zones.
- Work is primarily sedentary and computer-based, with the ability to perform the essential duties of the position with reasonable accommodation in accordance with applicable law.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
