SUMMARY OF POSITION:
Please note: This is an in-house position at Ora's corporate headquarters, located in Andover, MA.
Assists project managers in clinical conduct of ophthalmic clinical trials. Serves as point of contact for investigator sites and ensures compliance with protocol and overall clinical objectives. As a member of the clinical operations team, relies on instructions and pre-established SOPs to perform the functions of the job while working under supervision of a supervisor or manager. Performs day-to-day activities under the guidance of the clinical project managers. Placement at the CTA I, CTA II or Sr. CTA level will be determined based on the candidate’s qualifications.
- Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations.
- Participates in study start-up, conduct, and closeout activities.
- Collects and reviews site regulatory documents for accuracy and completion (e.g. 1572, Financial Disclosure documents, CLIA waivers).
- Assembles and distributes regulatory binders to clinical sites.
- Drafts and/or assists with the preparation of trial-related documents, tools and templates (start-up forms, ICFs, screening scripts, source documents, study logs).
- Supports project management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
- Assembles and/or reviews regulatory packages for trial-related submissions to IRB/IECs.
- Liaises with key members of the study team, including study site investigators and coordinators, monitors/clinical research associates and data managers.
- Maintains the Trial Master File (TMF) for all clinical projects.
REQUIRED SKILLS AND ATTRIBUTES:
- Ability to work in a virtual, cross-functional team environment.
- Sound analytical and problem solving skills; ability to act with a consistent sense of urgency and acute attention to detail.
- Knowledge of ICH/GCP guidelines and FDA regulations.
- Experience maintaining trial master files.
- Excellent verbal and written communication skills and proficiency in Microsoft Office.
- Commitment to consistently producing high quality work.
- Exceptional organizational and time management skills for maintaining multiple trials.
Bachelor of Science Degree, one or more years experience in clinical research or equivalent training and work experience. Previous ophthalmic research, ophthalmic technician or study coordinator experience preferred. Familiarity with the DIA TMF Reference Model desired, but not required. Recent graduates will be considered.