Senior Clinical Research Associate, Cardiac Catheter Products

📋 Description

• Provide case assistance to research sites across various studies with minimal supervision.

• Prepare and create project and study-related documentation including informed consent forms, clinical report forms (CRFs), study guides, study reference binders, and patient diaries.

• Coordinate the review of data listings and the preparation of interim and final clinical study reports.

• Take responsibility for monitoring clinical studies, which entails reviewing case report forms (CRFs), both paper and electronic data capture (EDC), and source documentation to ensure compliance with the protocol and the scientific integrity of the data.

• Develop study-specific monitoring tools and other related documents.

• Produce high-quality written monitoring reports, confirmation, and follow-up letters within the timelines specified by standard operating procedures (SOPs) and monitoring plans.

• Ensure that all missing action items (MAIs) from monitoring visits are resolved within the timelines established in monitoring plans.

• Review and approve essential regulatory documents across various studies.

• Assist the project team in formulating study metrics to ensure the efficient execution of clinical trials.

• Oversee clinical data to ensure that queries are resolved within the specified timelines of study objectives.

• Provide clinical support for the submission of trials to Institutional Review Boards (IRB)/Independent Ethics Committees (IEC) and regulatory authorities.

• Ensure compliance with study timelines across multiple studies.

• Mentor and coach other Clinical Research Associates (CRAs) in their development and training.

• Maintain a strong working knowledge of protocols and product development across multiple studies.

• Exhibit the ability to coordinate, organize, communicate, and manage site activities, knowing when to escalate issues to management or the clinical team.

• Demonstrate an excellent understanding of clinical research processes, Good Clinical Practices, International Conference on Harmonisation Guidelines, federal regulations, and applicable local laws related to clinical research investigations.

• Verify that the rights and well-being of study subjects are protected and confirm that written informed consent was obtained prior to each subject's participation in the study.

• Manage Investigational Product accountability, including storage, inventory, return/destruction, and dispensing/receipt records.

• Ensure compliance in reporting adverse events/serious adverse events in accordance with the protocol and relevant regulatory agencies.

• Manage the documentation, tracking, and escalation of Protocol Deviations.

• Participate in site audits, as required.

⛳️ Requirements

• BS/BA degree or equivalent experience.

• Over 5 years of experience directly supporting clinical research or relevant experience in a medical/scientific field.

• A minimum of 3 years of CRA experience in device or biotech clinical trials.

• Experience with cardiovascular devices is preferred.

• Certification as a CRA, such as CCRA, CCRP, or other CRA certification is strongly preferred.

• Proficient in Acrobat Adobe, Microsoft Word, Excel, PowerPoint, and Smartsheet; and capable of quickly mastering various other computer software programs.

• Knowledge of FDA and international regulations and guidelines, including but not limited to clinical strategy, Good Clinical Practices (GCPs), standard operating procedures (SOPs), submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting.

• Proficient in utilizing EDC and CTMS systems.

• Working familiarity with FDA, European regulatory, and EC procedures, as applicable.

• Excellent oral and written communication skills, complemented by strong presentation abilities.

• Possess clear and systematic thinking that showcases good judgment and problem-solving skills.

• Exceptional critical thinking and analytical abilities.

• Strong organizational skills with the capacity to work diligently and independently, exercising good judgment and taking initiative to complete both short-term and long-term projects, while recommending actions with minimal direction.

• Ability to collaborate as a team member, manage multiple tasks, and be adaptable to the ever-evolving work priorities and requirements of a dynamic, fast-growing company.

• Flexibility in working hours and readiness to travel 30%-50% of the time, including potential overnight and/or international travel.

• Capability to lift 10-15 pounds.

🏝️ Benefits

• Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, along with a 401k retirement savings plan.

• Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.

• Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedules, and a wellness program, including onsite gym and mindfulness classes.

• Diversity & Inclusion - A commitment to fostering a respectful work environment for our diverse workforce.