The Senior CRA is a seasoned professional with wide-ranging experience and a thorough understanding of GCP and ICH principles. S/he identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the Senior CRA will establish strong, positive relationships with both internal and external partners. The successful candidate contributes to the determination or development of methods and procedures at the project and company levels.
The Senior CRA may act as a CRA team lead and must be self-motivated, independent and able to work in a small team environment. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities. Mentoring and helping train less experienced CRAs will be important. Acting as the primary point of contact for investigator sites being responsible for ensuring the clinical trial is conducted according to CFR, ICH and GCP guidelines is a must. The Senior CRA is efficient at executing monitoring and other clinical trial management activities while tracking the progress of assigned studies/projects and identifying and resolving challenges to achieve target objectives.
Perform investigator site pre-study site qualification visits including collection of site regulatory documents
Assist with site start-up activities including site contracts and budget development/negotiation, and preparation of IRB submissions (including follow through to ensure successful outcome)
Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites
Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
Participate in/lead the Investigator/Initiation Meetings, ensuring the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in line with protocol requirements
Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)
Track the movement of laboratory samples and the resulting data, including the trans-shipment of samples to specialty laboratories, or movement of samples to sample-management storage.
Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions)
Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication
Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence, and schedules of payment
Identify and complete follow- up of SAEs at study sites
Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities
Ensure appropriate and timely submission of documents to the Trial Master File
Skills & Requirements:
Bachelor’ s Degree in health sciences related field, RN or related discipline required
Minimum 4 years field-based monitoring or other relevant experience.
Thorough knowledge of ICH GCP guidelines
Strong written and verbal communication ability
Strong PC skills (MS Word, MS Excel, MS Project)
Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
Experience with Outsourced Clinical Trials required