Sr. Clinical Research Associate (Cardiac Surgical Products)

Benefits

Qualifications

• •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
• •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
• •11 more items(s)

Responsibilities

• •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
• •23 more items(s)