Senior Clinical Research Associate

Cynet Systems; Sunnyvale (CA); On-site; USD 80,000 - 95,000; Full time

Job summary

A leading company in medical device manufacturing seeks a Senior Clinical Research Associate to manage and oversee clinical studies. The role demands strong knowledge of regulatory requirements and excellent communication skills working with various stakeholders. Candidates should have extensive experience in clinical trials and a relevant degree.

Qualifications

• 8 years of related experience with BA/BS or 6 years with Nursing degree.
• Experience in medical device trials and familiarity with Good Clinical Practices.
• Must manage CRAs and CTAs while being a self-starter.

Responsibilities

• Conduct pre-market and post-market clinical studies.
• Develop clinical study documentation and manage site initiation.
• Oversee compliance with regulatory requirements and data accuracy.

Skills

Knowledge of Clinical investigation

Clinical research/clinical trial management

Excellent communication skills

Proficiency in Microsoft Office Suite

Experience working with EDC systems

Education

BA/BS degree or equivalent

Master’s degree or MD/PhD preferred

Job description

• The Senior Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market clinical studies to ensure compliance with all regulatory requirements.
• The ideal candidate will have a 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.
• As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies (pre-market or post-market studies) with minimal supervision.
• The candidate will be required to work closely with clinical study managers, clinical trial assistants (CTAs), and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, contribute to clinical study reports, or help the development of clinical publications.
• The candidate is also expected to have experience reviewing, interpreting, and summarizing clinical literature.
• Contribute to all clinical research activities to ensure the successful management of clinical studies.
• Maintain and track clinical study data and help in investigator qualification and selection, scrutiny of potential patient recruitment, and overall study status/progress throughout the life of a study.
• Manage site start-up/activation process, including: 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 help 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 helps 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 and 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 the main liaison to participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking, and accountability, and study conduct oversight at the participating clinical sites.
• Partner with data management to help the data cleaning process.
• Drive review of safety events and partner on developing 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 help in study financial tracking by developing tracking tools as necessary.
• Assist the Clinical Study Manager on study scoping activities, including, but not limited to, the development of pre-study questionnaires, study design, and surgeon/site selection.
• Help with site audits and site audit preparation in anticipation of site inspections.
• Mentor junior CRAs and CTAs on monitoring and other study needs.

Required Skills and Experience:

• Previous experience implementing, helping, and managing medical device trials. Significant knowledge of clinical and/or outcomes research study design.
• Possess advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Parts 11, 50, 54, 81,2 and other applicable regulations.
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements.
• Clinical research/clinical trial management certification/education preferred.
• Prior experience working in a clinical setting is preferred.
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Excellent experience in protocol and ICF development, writing clinical section(s) for regulatory submission.
• Experience negotiating clinical research contracts and budgets.
• Must be able to work effectively on cross-functional teams.
• Must be able to travel 25-40% or based on business requirements (Due to the nature of the job).
• Must be able to manage multiple projects and/or manage different priorities.
• Excellent communication, presentation, and relational skills with high attention to detail and organization.
• Ability to learn quickly, adjust to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”).
• Ability to manage CRAs and CTAs and support management with relevant study updates.
• Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary, with a problem-solving mindset.
• Proficiency in Microsoft Office Suite and the PDF application.
• Experience working with electronic data capture (EDC) systems is required.
• Experience in clinical trial management systems preferred.
• Experience in the medical device industry is required.

Required Education and Training:

• Typically requires a minimum of 8 years of related experience with a BA/BS university degree or a minimum 6 years’ experience and a Nursing degree, a Master’s degree, or an MD or PhD with a minimum 3 years’ experience; or equivalent experience in a scientific field.

Preferred Skills and Experience:

• Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred.
• Knowledge of statistics, statistical methods, and design of experiment is highly preferred.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Health Care Provider and Research

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Cynet Systems by 2x

Get notified about new Clinical Research Associate jobs in Sunnyvale, CA.

Hayward, CA $80,000.00-$95,000.00 2 weeks ago

Clinical Trial Assistant II, Clinical Operations Process & Systems

San Francisco Bay Area $75,000.00-$90,000.00 2 weeks ago

Clinical Trial Assistant I, Clinical Operations

Santa Clara, CA $40.00-$45.00 20 hours ago

Clinical Trial Assistant I, Clinical Operations

San Mateo County, CA $40.00-$45.00 20 hours ago

Clinical Trial Assistant I, Clinical Operations

Assistant Clinical Research Coordinator (1 Year Fixed Term)

Research Associate I, Pharmaceutical Development (Contactor)

Clinical Research Assistant - Alzheimer's Disease

Assistant Clinical Research Coordinator (Hybrid Opportunity)

Stanford, CA $84,856.00-$97,021.00 6 days ago

San Francisco Bay Area $24.00-$27.00 2 hours ago

Clinical Lab Associate 1, Sun-Th AM Shift

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.