SUMMARY OF POSITION:
Assists in clinical study conduct for ophthalmic clinical projects and ensures compliance with protocol and overall clinical objectives. As a member of the clinical team, relies on instructions and pre-established SOP’s to perform the functions of the job while working under immediate supervision of a supervisor or manager. As a supervisor of a clinical team, oversees the conduct of study visits to ensure compliance with the protocol and clinical study objectives in conjunction with the Principal Investigator. Performs day to day activities under the guidance of the ophthalmic project managers and relevant therapeutic directors.
- Assists in ensuring the smooth and efficient day-to-day operation of clinical research and data collection activities at the site.
- Provides oversight and guidance in the conduct of clinical trials to the assigned clinical team.
- Acts as the liaison between the Principal Investigator and study project management team members.
- Interfaces with clinical monitors and Ora Site Operations staff to resolve data queries and address protocol deviations/violations.
- 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.
- Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and government regulations.
- Participates in study start-up, conduct, and closeout activities.
- Drafts and/or assists with the preparation of trial-related documents, tools and templates (start-up forms, ICFs, screening scripts, source documents, study logs).
- Collects and reviews site regulatory documents for accuracy and completion ( Financial Disclosure documents, CLIA waivers, etc) while maintaining the relevant parts of the Trial Master File.
- Ability to travel up to 10% of the time
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.
- Experience in a clinical practice conducting IRB approved research
- Experience managing site operations staff in the conduct of clinical research
- Knowledge of GCP/ICH regulations.
- Experience maintaining trial master files.
- Excellent verbal and written communication skills.
- Ability to display commitment to consistently producing high quality work.
- Exceptional organizational and time management skills in order to manage multiple trials.
Bachelor’s Degree in Nursing or Life Sciences, three or more years’ experience in clinical trials, or equivalent training and work experience. Ophthalmic trials experience preferred.