Sr. Clinical Research Associate (Cardiac Surgical Products)

About The Role

The Senior Clinical Research Associate (Sr. CRA) is responsible for managing and monitoring activities that will lead to successful execution of clinical studies at US and international clinical sites. This position will monitor patient recruitment, data and study related information related to clinical sites and study participation. 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 case support to research sites across multiple studies with minimal guidance.
• Prepares and develops project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries.
• Coordinates review of data listings and preparation of interim and final clinical study reports.
• Responsible for monitoring clinical studies, which includes review of case report forms (CRFs) both paper and/or electronic data capture (EDC), and source documentation to ensure adherence to the protocol 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 missing action items (MAIs) 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 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.
• Participates in site audits, as requested.
• May perform other duties as assigned.

To Excel, You Will Bring:

• BS/BA degree 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 device or biotech clinical trials.
• Cardiovascular 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 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.