The primary responsibility of Clinical Research Associate Manager (CRA Manger) is to oversee the planning, implementation, monitoring and site management of Adaptimmune Sponsored clinical studies in North America.
In this position you will ensure that all clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements in which the study is being conducted.
The CRA Manager is also responsible for oversight of Clinical Research Organizations (CROs) for outsourced CRA services in support of the monitoring activities of Adaptimmune clinical sites to ensure the effectiveness, professional and timely management of clinical trials Sponsored by Adaptimmune. You will also be responsible for selecting, developing and evaluating personnel to ensure the efficient operation of the function.
- Oversee the planning, implementation, monitoring and site management of all North American sites in Adaptimmune-sponsored clinical studies in accordance with Good Clinical Practice (GCP), ICH guidelines and country and local regulations.
- Select, develop and evaluate personnel to ensure the efficient operation of the function.
- Empower CRA to perform high quality monitoring.
- Build and establish quality measures for CRO oversight in respective to Site Management
- Ensure CRAs are trained appropriately and that monitoring/communication plans are maintained and current
- Review monitoring trip reports (for sites in region) and ensure that resolution of all action items are tracked
- Co-monitor at investigative sites to evaluate study site and field monitor performance
- Periodically review TMF to ensure maintained and up to date
- Support Site Management and Clinical Scientists in start-up activities and other supporting site management activities to ensure timely site initiation as needed including but not limited to conducting Site Qualification Visits.
- Work with Supplier Governance to develop request for proposal, evaluate, provide input into selection, and review bids of monitoring CROs.
- Perform all clinical monitoring tasks and / or remote visits, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines ensuring patient safety and integrity at all times.
- Act as the remote contact with assigned clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites. This includes managing / supporting site activities remotely, resolving site issues, and ensuring timely / high quality data entry at site level.
- Uses good judgement and has thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and Adaptimmune SOPs, including understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across all sites
- Build relationships with investigators and site staff as well as participate in Investigator and other external or internal meetings, arrange on-site visits and logistics (e.g. travel arrangements) and perform on site visits in accordance with the monitoring plan.
- Support the maintenance of guidelines, training programs, policies and procedures.
- Develop and maintain/evaluate key performance indicators for monitoring (including assessment of internal and external monitor, site performance, and trending of protocol deviations)
- Review and provide input into protocols, ICF, Study Procedure Manuals, CRF design, Clinical Study Reports or any other tracking or reports as needed
- Provide support in the identification of training gaps, may support development of training materials to meet the gap and provide training as required to improve core competency and skill set of new CRAs
- Performs in-house review of clinical database listings for completeness and accuracy
Qualifications & Experience
- Minimum of Bachelor’s degree in a relevant scientific field, and/or relevant scientific licensure (e.g. Registered Nurse)
- Relevant clinical experience > five (5) years in pharmaceutical, CRO, or biotechnology company including proven experience
- independently monitoring multiple clinical sites
- qualifying and initiating sites
- creating, implementing and monitoring processes for communication with sites and Adaptimmune on clinical trial progress, tracking, prospective planning, and enrolment strategies.
- Trial Master File and Essential Document knowledge
- Experience working with site personnel
- Experience writing monitoring reports
- Some previous experience with vendor oversight
- Knowledge of ICH/GCP and FDA regulations
- Experience with EDC systems
- Strong knowledge of clinical operations and the clinical site-specific regulatory process.
- Ability and willingness to travel to sites
Experience with oncology, biologics or cell and gene therapy is preferred.
Skills & Compentencies
- Highly motivated, independent, and a self-starter.
- Strong interpersonal skills and communication skills (both spoken and written).
- Ability to collaborate effectively with the study team, cross-functional team members, and external partners
- Strong leadership skills, self-motivated, adaptable to a dynamic environment
- Excellent planning, organization and problem solving abilities
- Excellent computer skills
- Timely submission of expense and trip reports and timesheets