Senior Clinical Research Associate, Cardiac Surgical Products
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Job Description
Sr. Clinical Research Associate managing and monitoring clinical studies in the bioelectric medicine field. Ensuring adherence to scientific validity and regulatory requirements for trials.
Responsibilities:
- 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.
Requirements:
- 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.
Benefits:
- A variety of health insurance plans and supplemental insurance options
- 401k retirement savings plan
- Paid time off
- Paid holidays
- Flexible work schedule
- Wellness program, including onsite gym and mindfulness classes
- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success
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