- Coordinate study start-up and study conduct activities, including: drafting ICF study specific template and TMF plan, approving study-specific essential documents list, managing and communicating the status of study progress and activities
- Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution.
- Mentor and train junior employees
- Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
- Lead in assessing current and new processes, finding opportunities and implementing solutions to improve efficiencies within and across related functional areas
- Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations
- Prepare materials for steering and investigator meetings
- Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
- Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
- Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
- Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees.
- Provide oversight of and insight into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
- Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
- Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition.
- Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
- Edit/amend informed consent documents.
- Bachelor's Degree in a related Science field
- 5 years of field monitoring experience
- Experience working in medical device industry
- Excellent written and verbal communication, presentation, interpersonal, and analytical skills
- Proven problem-solving and critical thinking skills
- Demonstrated expertise in MS Office Suite, including Word, Excel, Adobe
- Ability to travel up to 65%
- Previous experience working at medical device Sponsor
- Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification)
- Must upload written cover letter with application submission
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Senior Clinical Research Associate - Sacramento, United States - J&J Family of Companies
Description
Senior Clinical Research Associate WDescription
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Clinical Research Associate. _Remote work options may be considered on a case-by-case basis and if approved by the Company_
_At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at_Reporting to the Manager, Clinical Research Associates, the person in this role is responsible for the management of day-to- day aspects of investigational site activities on assigned clinical trials.
The Senior Clinical Research Associate should ensure compliance with international guidelines, local regulations and corporate policies and procedures.Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as part of a collaborative team.
This person will be fully engaged and busy from the first day and we guarantee there will never be a dull moment.
Our team focuses on future development of the Impella platform, including clinical studies, data science and new clinical and physiological applications.
Qualifications
Key Responsibilities:
Qualifications:
Education:
Required:
Preferred:
Other:
This job posting is anticipated to close on The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $100,000 to $135,000. The Company maintains highly competitive, performance-based compensation programs.For additional general information on company benefits, please go to:
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location NA-US-4887-Danvers
Other Locations NA-United States
Organization ABIOMED Inc.(6942)
Job Function Clinical Development & Research & Non-MD
Req ID: W
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