Senior Clinical Research Associate, Cardiac Catheter Products

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support for case management at research sites across various studies with minimal oversight.

• Prepare and create project and study-related documentation such as informed consent 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.

• Responsible for monitoring clinical studies, which includes reviewing case report forms (CRFs) in both paper and/or electronic data capture (EDC) formats, as well as source documentation to ensure compliance with the protocol and scientific integrity of the data.

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

• Deliver high-quality written monitoring reports, confirmation letters, and follow-up communications within the timelines established by SOPs and monitoring plans.

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

• Oversee the review and approval of essential regulatory documents across multiple studies.

• Assist the project team in creating study metrics to facilitate the efficient execution of clinical trials.

• Manage clinical data to ensure that queries are resolved within the stipulated timelines aligning with study objectives.

• Provide clinical support for trial submissions to IRB/IEC and regulatory authorities.

• Ensure compliance with study timelines across various studies.

• Coach and mentor other Clinical Research Associates (CRAs) in their development and training.

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

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

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

• Verify that the rights and welfare of study subjects are protected and ensure that written informed consent is obtained prior to each subject's participation in the study.

• Handle Investigational Product accountability, which includes product storage, inventory management, returns/destruction, and dispensing/receipt records.

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

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

• Participate in site audits when requested.

⛳️ Requirements

• Bachelor's degree or equivalent experience.

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

• At least 3 years of Clinical Research Associate (CRA) experience in clinical trials related to devices or biotechnology.

• Experience with cardiovascular devices is preferred.

• Certification as a CRA, such as CCRA, CCRP, or other CRA certifications, is highly desirable.

• Proficient in Adobe Acrobat, Microsoft Word, Excel, PowerPoint, and Smartsheet; and the ability to quickly learn various other 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 utilizing EDC and CTMS systems.

• Familiarity with FDA, European Regulatory, and EC procedures, as applicable.

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

• Clear and systematic thinking that reflects sound judgment and problem-solving skills.

• Outstanding critical thinking and analytical skills.

• Strong organizational abilities, capable of working diligently with minimal guidance, using good judgment, taking initiative to accomplish both short- and long-term projects, and recommending actions with limited direction.

• Capacity to collaborate as a team member, manage multiple tasks, and adapt flexibly to the dynamic priorities and requirements of a fast-growing company.

• Willingness to work flexible hours and travel 30%-50% of the time; overnight and/or international travel may be necessary.

• Ability to lift 10-15 pounds.

🏝️ Benefits

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

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

• Work-Life Balance - Enjoy paid time off, paid holidays, a flexible work schedule, and a wellness program that includes an onsite gym and mindfulness classes.

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