Sr. Clinical Research Associate (Cardiac Catheter Products)

About the role

The Sr. Clinical Research Associate (Sr. CRA) will manage and monitor activities leading to the successful execution of clinical studies at US and international clinical sites. Responsibilities include:

• Providing case support to research sites across multiple studies with minimal guidance.
• Preparing and developing project and study-related documents such as informed consent forms, CRFs, study guides, study reference binders, and patient diaries.
• Coordination of review of data listings and preparation of interim and final clinical study reports.
• Monitoring clinical studies, reviewing CRFs, and ensuring adherence to the protocol and scientific validity of the data.
• Developing study-specific monitoring tools and related documents.
• Delivering high-quality written monitoring reports, confirmation, and follow-up letters within specified timelines.
• Ensuring all missing action items (MAIs) from monitoring visits are closed within specified timelines.
• Reviewing and approving essential regulatory documents across multiple studies.
• Aiding the project team in developing study metrics to ensure efficient trial execution.
• Overseeing clinical data to ensure queries are closed within stipulated timelines.
• Providing clinical support for submission of trials to IRB/IEC and regulatory authorities.
• Ensuring adherence to study timelines across multiple studies.
• Coaching and mentoring other Clinical Research Associates (CRAs).
• Maintaining a strong working knowledge of protocols and product development across multiple studies.
• Demonstrating ability to coordinate, organize, communicate, and manage site activities, escalating issues as necessary.
• Verifying the rights and well-being of study subjects are protected and verifying that informed consent was obtained before each subject's participation in the study.
• Performing Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
• Ensuring compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies.
• Managing Protocol Deviation documentation, tracking, and escalation.
• Participating in site audits, as requested.

Responsibilities

To make an impact, the Sr. CRA will:

• Provide case support to research sites across multiple studies with minimal guidance.
• Prepare and develop project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries.
• Cover data listings and prepare interim and final clinical study reports.
• Monitor clinical studies, review CRFs, and ensure adherence to the protocol and scientific validity of the data.
• Develop study-specific monitoring tools and related documents.
• Deliver high-quality written monitoring reports, confirmation, and follow-up letters within specified timelines.
• Ensure all missing action items (MAIs) from monitoring visits are closed within specified timelines.
• Review and approve essential regulatory documents across multiple studies.
• Aid the project team in developing study metrics to ensure efficient trial execution.
• Oversee clinical data to ensure queries are closed within stipulated timelines.
• Provide clinical support for submission of trials to IRB/IEC and regulatory authorities.
• Ensure adherence to study timelines across multiple studies.
• Coach and mentor other Clinical Research Associates (CRAs).
• Maintain a strong working knowledge of protocols and product development across multiple studies.
• Demonstrate ability to coordinate, organize, communicate, and manage site activities, escalating issues as necessary.
• Verify the rights and well-being of study subjects are protected and verify that informed consent was obtained before each subject's participation in the study.
• Perform Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
• Ensure compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies.
• Manage Protocol Deviation documentation, tracking, and escalation.
• Participate in site audits, as requested.

Requirements

• BS/BA degree or equivalent experience.
• 5+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
• At least 3 years of CRA experience in device or biotech clinical trials.
• Cardiovascular device experience 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.

Qualifications

• Excellent oral, written communication skills with strong presentation skills.
• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies.
• Excellent critical thinking analytical skills.
• Strong organizational skills with the ability to work conscientiously and with minimal direction, using good judgment, 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 30%-50% of the time, overnight and/or international travel may be required.
• Ability to lift 10-15 pounds.

Skills

• 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.

Benefits

Pulse Biosciences offers a comprehensive benefits package including:

• A variety of health insurance plans and supplemental insurance options.
• A 401(k) retirement savings plan.

Pay

Competitive salary and benefits package.

Schedule

Full-time position with flexible work schedule.