Responsible for overseeing a team of Clinical Research Associates (CRAs) assigned to a project who provide qualification, selection, monitoring, and close out of sites performing clinical trial(s) as well as monitor’s clinical sites on behalf of Ora, Inc. Reviews the work load requirements and provides resourcing for all clinical field activities. Ensures that staff perform their duties in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization- Good Clinical Practice (ICH-GCP).
Provides input in the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, study timeline management, monitoring plans, site reference manuals, pharmacy manuals, and laboratory manuals, training materials, annotated visit reports and site initiation visit slide presentation. Further is the primary author of the Clinical Monitoring Plan.
Supports and provides input to the implementation and conduct of clinical trials focusing on trial planning, enrollment, site monitoring, data quality and study reporting.
Mentors CRAs and conducts on-site QA visits with CRAs. In the event of performance concerns, evaluates cause(s), implements CAPAs (Corrective Action Preventative Action Plans) to manage and/or mitigate risk to the study.
Provides on the job training as well as oversight of CRAs to ensure compliance with both internal and industry policies and regulations.
With assistance/guidance by management, the Lead CRA evaluates clinical trial resourcing requirements for the planned project including qualification, training, monitoring and support of sites during the conduct of the trials.
Developing the clinical monitoring plan for the assigned project including the development of annotated trial specific site visit reports
Liaises with doctors/consultants or investigators conducting the trial as required to solicit feedback on the performance of the Ora clinical team and/or areas for development and focus
Acts as the clinical liaison with Project Management and Sponsor regarding clinical monitoring related questions
Attends Project Meetings and teleconferences to provide updates on the ongoing and planned monitoring activities.
Conducts and manages CRA teleconferences and provides detailed summary of Project/Sponsor Team meeting findings which relate to trial conduct and monitoring
Develops, tracks and reports metrics to evaluate the clinical research associate and site’s performance to the project team and management. In the event of performance concerns, evaluates cause, implements CAPAs (Corrective Action Preventative Action Plans) to manage and/or mitigate risk to the study.
Partners with the project team, research sites, and sponsor on strategies to drive subject recruitment and support the project timelines. Works with the clinical research associates and other members of the project team to ensure data is being collected and queries closed out per the clinical monitoring plan and clinical protocol. Further, periodically reviews data entry, query listings and Trial Master File to identity potential issues or inconsistencies that could signal problems with data collection, regulatory document filing or monitoring processes.
Provides support for the processing of data queries.
Reviews and approves monitoring visit reports.
Co-monitor as required to provide coaching and manage performance of CRAs
Plan and participate in investigator meetings.
Liaise with project management in the management of AEs & SAEs and SAE reports.
Prepares and participates in bid defense meetings
REQUIRED SKILLS AND ATTRIBUTES:
Strong leadership skills and the ability to lead teams and mentor other CRAs.
Ability to monitor and report on the progress of the trial from start-up to completion.
Capacity to routinely assess protocol and GCP compliance.
Strong attention to detail in order to review completeness of the investigator site file.
Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
Ability to read and demonstrate a comprehension of a clinical research protocol as well as understand the importance of following the protocol.
Demonstrate an understanding of 21 CFR sections 11, 50, 54, 56, 312, 314 and 812 and familiarity with the Nuremburg Code, the Belmont Report, the Declaration of Helsinki (1989), and the ICH guidelines governing GCPs.
Attention to detail, organizational skills, interpersonal skills, and effective oral and written communication skills.
Availability to travel up to 25% of the time.
Bachelor’s degree in applied or life science
Minimum of 5 years experience in clinical trials, preferably drug trial monitoring, or equivalent training and work experience.
Prior Ophthalmic and Lead CRA experience preferred yet not mandatory.