Associate, Clinical Research - Irvine, United States - Jenavalve Technology Inc

Jenavalve Technology Inc

Verified Company

Irvine, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Job Title:
Associate, Clinical Research

Supervisor/Manager Title:
Senior Manager, Clinical Affairs

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.
Maintain Trial Master Files and trackers for clinical trials.
Manage trialrelated regulatory documents and provide followup 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 monitoring of sites on an asneeded basis.

Required Education and Experience:

At least 1 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.
Some knowledge of GCPs governing the conduct of clinical trials, 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.

Specialist, Clinical Affairs