Sr. Clinical Research Associate (Soft Tissue Ablation)

About the Role

The Sr. Clinical Research Associate (Sr. CRA) is responsible for managing and monitoring activities that will lead to the successful execution of soft tissue ablation clinical trials. This position supports study planning and site start-up activities, and monitors patient recruitment, data quality, and study-related activities associated with clinical site participation. The Sr. CRA supports primarily U.S.-based clinical studies, including feasibility, post-market, and non-IDE research, with opportunities to contribute to future international and pivotal clinical trials. Ensures that duties are performed in accordance 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).

To Make an Impact, You Will:

• Provides on-site clinical monitoring and procedural case support to research sites across multiple studies, including coordination with investigators, research staff, and cross-functional internal stakeholders with minimal guidance.
• Prepares and develops project and study-related documents including informed consent forms, CRFs, study guides, site training materials, study binders, and patient diaries, as applicable.
• Coordinates review of data listings and preparation of interim and final clinical study reports.
• Responsible for monitoring clinical studies, including review of case report forms (CRFs) both paper and/or electronic data capture (EDC), source documentation, procedural data, device accountability records, safety events, and other study records to ensure protocol adherence, subject safety, and scientific validity of the data.
• Responsible for developing study specific monitoring tools and other related documents.
• Delivers high quality written monitoring reports, confirmation and follow-up letters within the timelines of SOPs and monitoring plans.
• Ensures that all action items from monitoring visits are closed within the timelines of monitoring plans.
• Responsible for reviewing and approving essential regulatory documents across multiple studies.
• Assists the project team in developing study metrics to ensure the efficient execution of a clinical trial.
• Oversees clinical data to ensure queries are closed within stipulated timelines of study goals.
• Provides clinical support for submission of trials to IRB/IEC and regulatory authorities.
• Ensures adherence to study timeline across multiple studies.
• Coaches and mentors other Clinical Research Associates (CRAs) in development and training.
• Maintains strong working knowledge of protocols and product development across multiple studies.
• Demonstrates ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team.
• Demonstrates an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations.
• Verifies the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the study.
• Performs device accountability, including storage, inventory, return/destruction, and disposition/receipt records.
• Ensures compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies.
• Manages Protocol Deviation documentation, tracking, and escalation.
• Participates in site audits, as requested.

To Excel, You Will Bring:

• BS/BA degree in relevant scientific discipline or equivalent experience.
• 5+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
• Must have at least 3 years of CRA experience in medical device or biotech clinical trials.
• Cardiovascular, interventional, surgical, image-guided, or ablation device experience preferred.
• Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.
• Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and Smartsheet; and the ability to quickly become proficient in a variety of other computer software programs.
• Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting.
• Proficient in using EDC and CTMS systems.
• Working knowledge of FDA, European Regulatory and EC procedures, as applicable.
• Excellent oral, written communication skills with strong presentation skills.
• Clear and systematic thinking that demonstrates good judgement and problem-solving competencies.
• Excellent critical thinking analytical skills.
• Strong organizational skills with the ability to work conscientiously and with minimal direction, using good judgement, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
• Flexibility in work hours and readiness to travel up to 40% of the time, overnight and/or international travel may be required.
• Ability to lift 10-15 pounds.