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Senior Clinical Research Associate (Partially Remote)

Company: Vivonics, Inc.
Location: Austin
Posted on: January 15, 2022

Job Description:

OVERVIEW
Vivonics, Inc. is a biomedical engineering technology development firm specializing in developing innovative technologies that improve human health and performance from the initial concept to viable products.

The company seeks an experienced and detail-oriented Sr. Clinical Research Associate to support clinical research of its novel medical device solutions. -The Senior Clinical Research Associate will, in coordination with the Principal Investigator(s) and Program Manager(s), be responsible for the supervision of clinical studies to ensure delivery on time, within budget, and in compliance with Good Clinical Practice (GCP), FDA, IRB, and the Standard Operating Procedures (SOP) of Vivonics.

DUTIES AND RESPONSIBILITIES
The Senior Clinical Research Associate assists in the execution of clinical studies to support new medical device development and regulatory approval. -This position offers a unique combination of clinical project management and clinical operations in a collaborative cross-functional team environment of engineers and clinicians. -Specific duties will include:
- - - - - -Serve as the primary contact for assigned clinical studies
- - - - - -Assist with the development of study design, protocols, case report forms, and other study-specific documents essential to appropriate implementation of clinical investigations
Support the design, preparation, planning, implementation, and review of clinical studies to support new medical device development and regulatory approval
Recruit, consent, and conduct clinical study or trial activities as outlined in the respective protocols
Provide coordination and oversight for studies performed by investigators at collaborating institutions under local IRB
Work with IRB's and oversight organizations at funding sponsor organizations (NIH OHRP, Army HRPO, Navy BUMED HRPP, etc.) to provide information and obtain required approvals.
- - - - - -Work with investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting, and ethical practice; Assist with preparation and execution of investigator meetings
- - - - - -Monitor clinical studies through all phases, which include clinical project management activities such as budgets and timelines
Assist in the review and organization of clinical data according to SOP, ICH/GCP, and HIPAA standards
Work with hospital and government review boards to gain necessary approvals required for the clinical studies
Ensure adequate training materials are created and that the clinical sites are appropriately trained
May participate in both internal and external clinical study-related audits.
Responsible for data monitoring

SKILLS AND REQUIREMENTS
- - - - - -BS in Life Sciences, Healthcare, Biomedical Engineering or related field
- - - - - -At least three years of working experience in the conduct and management of clinical studies (experience with studies for monitoring devices is a plus)
Excellent record-keeping, time management, decision-making, customer service, and interpersonal skills
Experience qualifying, initiating, interim monitoring, and closing out investigational sites
- - - - - -Ability to work independently with minimal supervision
- - - - - -Domestic travel required (5-10%)

Applicants should have strong planning and organizational skills, as well as excellent written communication skills. -Experience with medical product development under ISO-13485 and FDA QSR is a plus.

Vivonics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Principals only. No recruiters please.

Keywords: Vivonics, Inc., Austin , Senior Clinical Research Associate (Partially Remote), Healthcare , Austin, Texas

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