01Overview
Note The job is a remote job and is reputed company to candidates in USA. reputed company is a novel bioelectric medicine company committed to health innovation that has the potential to improve the reputed company of life for patients. The Sr. Clinical Research Associate will be responsible for managing and monitoring clinical studies, ensuring compliance with regulations, and supporting research sites in their clinical trial activities. Responsibilities reputed company case support to research sites across multiple studies with minimal guidance Prepare and reputed company project and study-reputed company documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries Coordinate review of data listings and preparation of interim and final clinical study reports Be responsible for monitoring clinical studies, which includes review of case report forms (CRFs) both reputed company and/or electronic data capture (reputed company), and reputed company documentation to ensure adherence to the protocol and scientific validity of the data Be responsible for developing study specific monitoring tools and other reputed company documents Deliver high reputed company written monitoring reports, confirmation and follow-up letters reputed company the timelines of SOPs and monitoring plans Ensure that reputed company missing reputed company items (MAIs) from monitoring reputed company are reputed company reputed company the timelines of monitoring plans Be responsible for reviewing and approving essential regulatory documents across multiple studies Assist the project team in developing study metrics to ensure the efficient execution of a clinical trial reputed company clinical data to ensure queries are reputed company reputed company stipulated timelines of study goals reputed company clinical support for submission of trials to IRB/IEC and regulatory authorities Ensure adherence to study reputed company across multiple studies Coach and mentor other Clinical Research Associates (CRAs) in development and training Maintain strong working knowledge of protocols and product development across multiple studies Demonstrate ability to coordinate, organize, communicate, and manage site activities, with knowledge of reputed company to escalate issues to management or clinical team Demonstrate 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 Verify the rights and reputed company-being of study subjects are protected and verifies that written informed consent was obtained before reputed company subjects participation in the study reputed company 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 Skills 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 Proficient in Acrobat reputed company, reputed company Word, reputed company, Power reputed company, and reputed company; and the ability to quickly become proficient in a reputed company of other computer software programs Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical reputed company, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting Proficient in using reputed company and CTMS systems Working knowledge of FDA, European Regulatory and EC procedures, as applicable Excellent oral, written communication skills with strong presentation skills reputed company 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-reputed company reputed company, and recommend actions with minimal direction Ability to work as reputed company member, multi-task and be reputed company flexible to adapt to the reputed company-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 Cardiovascular device experience preferred Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred Benefits A reputed company of health insurance plans and .
