Senior Clinical Trials Coordinator
Ora
Summary
The Senior Clinical Trial Coordinator (SCTC) is responsible for the coordination and administration of clinical trials under the direction of the Dir. Clinical Projects. The SCTC will develop, implement, and coordinate study and administrative procedures for the successful management of clinical trials. The SCTC will perform diverse administrative duties requiring analysis, sound judgment, attention to detail, and a high level of knowledge of study specific protocols. The SCTC will take on additional leadership responsibilities including onboarding, training, and mentorship of more junior Clinical Affairs team members.
Job description
Job Duties
- Coordinates and supports activities for multiple studies under the direction of the Dir. Clinical Projects.
- Assists Clinical Affairs team with development of study specific documents.
- Responsible for set-up, maintenance, and archival of the Trial Master File (TMF).
- Collects and tracks regulatory documents for multiple studies to ensure completeness of TMF and audit readiness.
- Supports drafting of Clinical Trial Agreement (CTA), budget, and requests study specific Confidential Disclosure Agreements (CDA).
- Creates study specific Regulatory Binder and ships to clinical sites.
- Manages all aspects of study specific payments (e.g. vendors, sites) in accordance with executed agreements and approved budgets.
- Tracks payments and expenses against the department’s budget and regularly interfaces with Finance Department on study accruals.
- Communicates with principal investigators, hospital research, and legal staff to coordinate execution of a study.
- Provides support for study specific meetings (e.g. investigator, core teams, data safety monitoring board (DSMB)), drafts and circulates meeting minutes.
- Assists in remote and/or on site study monitoring.
- Assists Clinical Affairs team with site training (e.g. onsite or remote) to electronic data capture (EDC) system or protocol as needed.
- Designs and updates study specific newsletters and circulates final document to sites.
- Responsible for study device/equipment shipments, accountability, and reconciliation.
- Maintains Sunshine Act reporting records for assigned studies and reports updates to the Olympus Transparency Reporting team as needed.
- Ensures compliance to applicable clinical study regulations and Olympus SOPs, WIs, and policies.
Job Qualifications
Required:
- Minimum of 1 year of experience working for a medical device, biotech, or pharmaceutical company.
- Ability to support multiple projects for Olympus Clinical Affairs teams at different locations.
- Well organized, detail oriented, and accountable.
- Strong written, oral, and interpersonal communication skills.
- Flexible, self-motivated, and works well under pressure in a dynamic environment.
- Proficiency with Microsoft Office and electronic data capture (EDC) systems.
- MS Word.
- MS Excel.
- MS Outlook.
- MS PowerPoint.
- Ability to travel up to 10% of the time.
Preferred:
- Associate’s or Bachelor’s degree in a scientific, healthcare, or business-related field is preferred.
- Experience working for a medical device, biotech, or pharmaceutical company in a Medical Affairs-related function, preferably.
- Some experience organizing and analyzing data preferred.
Requirements
- Minimum of 1 year of experience working for a medical device, biotech, or pharmaceutical company.
- Ability to support multiple projects for Olympus Clinical Affairs teams at different locations.
- Well organized, detail oriented, and accountable.
- Strong written, oral, and interpersonal communication skills.
- Flexible, self-motivated, and works well under pressure in a dynamic environment.
- Proficiency with Microsoft Office and electronic data capture (EDC) systems.
- MS Word.
- MS Excel.
- MS Outlook.
- MS PowerPoint.
- Ability to travel up to 10% of the time.
- Associate’s or Bachelor’s degree in a scientific, healthcare, or business-related field is preferred.
- Experience working for a medical device, biotech, or pharmaceutical company in a Medical Affairs-related function, preferably.
- Some experience organizing and analyzing data preferred.
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Employee Assistance Program
- Wellbeing Programs
- Paid Vacation & Sick Time
- Paid Parental Leave
- Adoption Assistance
- Paid Holidays
- On-Site Child Daycare
- Café
- Fitness Center
- Paid Volunteering
- Charitable Donation Matching
- Training & Development Programs
- Paid Educational Assistance
Company overview
Ora is the world's leading full-service ophthalmic drug and device development firm, operating as a specialized contract research organization (CRO) focused exclusively on ophthalmology. Founded in 1974 and headquartered in Andover, Massachusetts, the company has over 45 years of experience in advancing eye care innovations globally. Ora provides comprehensive research and development services spanning preclinical studies, clinical trials, regulatory strategy, and product development for both pharmaceutical and medical device companies. With operations across the United States, United Kingdom, Australia, and Asia, the company has helped clients achieve more than 85 product approvals to date. Ora's expertise covers a wide range of ophthalmic conditions including allergy, dry eye, retina diseases, glaucoma, and anti-infective therapies. The company employs over 500 ophthalmology specialists who utilize proprietary clinical models, integrated data solutions, and global regulatory strategies to accelerate product development from concept to market. Ora serves a diverse client base ranging from startups to global pharmaceutical and device companies, positioning itself as the trusted partner for ophthalmic innovation worldwide.