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Senior Associate, Clinical Research
1 week ago
Job Title: Senior Associate, Clinical Research
Supervisor/Manager Title: Senior Manager, Clinical Affairs
Job Description Summary: The Senior Clinical Research Associate will report to the Associate Director, Clinical Programs, and will play a key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate will have a thorough knowledge of Good Clinical Practices (GCP) and applicable regulations.
Job Responsibilities:
- Support site management and interact with site coordinators, investigators, and field monitors in collecting data and resolving queries to meet the protocol requirements in a timely manner.
- Ensure quality data management activities – i.e., data review, query generation and resolution. Generate status reports to clinical staff and management.
- Generate queries to resolve data issues and apply corrections to database.
- Act as a point person for all data related to clinical group, and to provide data to cross-functional departments.
- Conduct EDC training to external teams and sites.
- Maintain Trial Master Files and trackers for clinical trials.
- Manage trial-related regulatory documents and provide follow-up action listings to ensure that all clinical documentation required by regulations and JenaValve procedures is current.
- Conduct periodic audits of internal files to ensure compliance per site Institutional Review Board (IRB) and/or Ethics Committee (EC) policy (i.e. IRB continuing review approval period and expiration dates).
- Provide clinical operational support during preparation for and conduct of all clinical audits and inspections.
- Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives.
- Partner with management to manage external vendors, including ongoing supplier qualification.
- Assist field clinical monitors in preparation for site training and monitoring visits
- Support co-monitoring of local sites on an as-needed basis.
Qualifications
Required Education and Experience:
- 2+ year of experience in clinical trial research is required (preferred in medical devices).
- Advanced degree in a biological science / pharmacy/ nursing desired.
Skills and Abilities Required for This Job:
- Proficient in clinical trial management and electronic data capture systems to document and record information.
- Excellent communication skills (written and verbal English) so as to be able to build effective relationships with trial center staff and colleagues.
- Deep knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Directive 93/42/EEC, ISO14155 and ICH guidelines.
- Very organized and able to pay close attention to detail.
- Team player with a willingness to help where needed and work with diverse people.
- Ability to travel up to 20% time.
