Job DescriptionPrimary Function of the PositionThe Senior Clinical Research Associate will play a vital role in supporting pre-market clinical studies of investigational drugs for the Fluorescence Imaging group, ensuring full compliance with regulatory requirements. The ideal candidate will have in-depth knowledge of clinical research in drug trials, including Good Clinical Practice (GCP) and relevant US regulations for human subjects.
As a member of the Clinical Fluorescence Imaging team, this individual will collaborate with key stakeholders and contribute to the successful execution of pre-market clinical studies, working independently with minimal supervision. The role will involve close coordination with Senior Clinical Project Managers, the Head of the Fluorescence Imaging Clinical Team, and other team members.
The Sr CRA will also travel frequently to Investigational Sites to conduct co-monitoring along with the assigned Field CRA(s)/Monitor(s) assigned to specific investigational sites by the CRO.
Essential Job Duties- Contribute to all clinical research activities to ensure the successful start-up and management of clinical studies through FDA approval.
- Maintain and track clinical study data monitored and help in Investigator, Sub-Investigators qualification and selection, training, scrutiny of potential patient recruitment, and overall study status/progress throughout the life of a study.
- Co-Management of site start-up/activation process, including heavy contribution to the preparation of study-related documents and complete checklists, able to help with clinical trial agreements and budget negotiation, finalization of clinical monitoring plan, training materials, etc.
- Assist with eCRFs/EDC system, CTMS, eTMF and imaging Core Labs.
- Assist with review of IRB submissions, consents and applicable regulatory documentation with follow-through to ensure successful outcomes.
- Assist with amendments clinical study documents (ICF, CRFs, protocols, Monitoring Plan, study tools, etc.) as needed and assist clinical sites with institutional review board submission if necessary.
- Experienced with performing on-site and/or remote site qualification visits, site initiation visits, interim co-monitoring visits, and site close-out visits with or without the CRO.
- Conduct clinical study co-monitoring to ensure regulatory and protocol compliance and overall data accuracy in accordance with the study clinical monitoring plan.
- Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites to ensure regulatory and protocol compliance and overall accuracy.
- Assist and support participating clinical trial sites, to ensure timely data entry, data integrity, query resolution, investigational drug accountability, and study conduct oversight at the participating clinical sites.
- Partner with data management (CRO) to help the data cleaning process.
- Assist with the development and management of study electronic clinical trial master file (eTMF) and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)
- Assist the Sr Clinical Project Manager on study scoping activities, including, but not limited to, the development of pre-study questionnaires, study design, and surgeon/site selection.
- Assist Investigational sites with site audits preparation in anticipation of site inspections as well as assist during actual audits.
- Assist with internal and external audits preparation as well as during actual audits.
- Assist with SIV preparation and presentations.
- Assist with Investigators meetings preparation and presentations, including logistics and planning.
QualificationsQualificationsRequired Skills and Experience- Previous experience implementing pharmaceutical trials. Significant knowledge of clinical and/or outcomes research study design. Experience with surgical trials is preferred.
- Possess advanced knowledge of Clinical investigation of investigational drugs for human subjects.
- Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements.
- Clinical research/clinical trial management certification/education preferred.
- Excellent ability to interact with physicians and other professionals inside and outside the company.
- Excellent communication skills.
- Experience with protocol and ICF development, and related amendments.
- Experience negotiating clinical research contracts and budgets.
- Must be able to work effectively cross-functionally.
- Must be able to travel up to 40%.
- Must be able to manage multiple priorities.
- Excellent communication, presentation and relational skills with high attention to detail and organization
- Ability to learn quickly, adjust to shifting requirements, and self-educate on different as applicable to clinical projects ("Self-starter attitude").
- Exhibits solid work ethic to help meet tight timelines and/or multiple priorities when necessary with a problem-solving mindset.
- Proficiency in Microsoft Office Suite, PDF applications.
- Experience working with electronic data capture (EDC) systems required.
- Experience in clinical trial management systems.
- Previous experience implementing, helping and managing drug trials.
- Significant knowledge of clinical and/or outcomes research study.
- Possess advanced knowledge of Clinical investigation of Investigational drugs for human subjects - Good Clinical Practice and other applicable regulations.
- Knowledge of clinical research and monitoring requirements.
- Excellent ability to interact with physicians and other professionals inside and outside the company.
QualificationsRequired Education and Training- Minimum of 8 years of related experience with a BA/BS university degree; or a minimum 6 years' experience and a Nursing degree, a Master's degree, or an MD or PhD with a minimum 5 years' of clinical research experience.
Preferred Skills and Experience- Knowledge of statistics, statistical methods, and design of experiment is preferred.
- Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred.
Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
