- Contribute to all clinical research activities to ensure successful management of clinical studies under the direct supervision of Clinical Affairs manager with dotted lines to clinical study manager.
- Maintain and track clinical study data and support in investigator qualification and selection, analysis of potential patient recruitment, and overall study status/progress throughout the life of a study.
- Heavy contribution to the preparation of study related documents (protocols, case report forms (CRFs) or eCRFs, draft informed consent forms (ICF) and complete checklists, able to support in clinical trial agreements and budget negotiation, clinical monitoring plan),
- Organizing IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful outcomes.
- Amends clinical study documents (ICF, CRFs, Monitoring Plan, etc...) as needed and support clinical sites with institutional review board submission as necessary.
- Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits
- Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan.
- Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites to ensure regulatory and protocol compliance and overall accuracy.
- Serve as main liaison to participating clinical trial sites with focus on data entry, query resolution, investigational device tracking and accountability, and study conduct oversight at the participating clinical sites.
- Collaborate with data management to support data cleaning process
- Lead review of safety events and collaborate on development of narrative and reporting as needed
- Develop and manage study trial master file and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)
- Track, process and manage site payments and support in study financial tracking by developing tracking tools as necessary.
- Assist Clinical Study Manager on study scoping activities, including but not limited to development of pre-study questionnaires, study design and surgeon/site selection
- Support site audits and site audit preparation in anticipation of site inspections
- Possess advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812 and other applicable regulations
- Typically requires a minimum of 8 years of related experience with a BA/BS university degree; or 6 years experience and a Nursing degree, a Master's degree, or a MD or PhD with 3 years experience; or equivalent experience in a scientific field
- Clinical research/clinical trial management certification/education preferred
- Prior experiences working in a clinical setting is preferred
- Must be clinically savvy and possess time management, organizational skills and problem-solving skills.
- Excellent written and oral communication skills and interpersonal skills with high attention to detail
- Ability to work successfully in a team environment and ability to prioritize and manage multiple tasks as necessary.
- Proficiency in Microsoft Office Suite, PDF application
- Experience working with electronic data capture (EDC) systems required
- Experience in clinical trial management systems preferred
- Experience in medical device industry required
- Must be able to travel up to 40%
- Ability to multi-task and work in a dynamic environment with simultaneous projects/tasks
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Clinical Research Associate 3 - Sunnyvale, United States - TalentBurst
Description
Role:
Clinical Research Associate 3ContractFully RemoteJob DescriptionPrimary Function of Position:The Senior Clinical Research Associate will report to Manager, Clinical Affairs, and will play a key role to proactively support the conduct of pre-market and post-market clinical studies to ensure compliance with all the regulatory requirements.
The ideal candidate will have thorough knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR part 812, 50, 54, and other applicable regulations.
Roles & Responsibilities:
Manage site start-up/activation process, including:
QualificationsSkills, Experience, Education, & Training:
