Remote - In-House Clinical Research Associate - Medical Device

A highly reputable medical device corporation is currently hiring for an In-House Clinical Research Associate to work remotely in the United States.

Description:

• Plan and execute the design and study startup activities of company-sponsored studies (including Sponsor-Investigator studies).
• Works collaboratively with company’s Biometrics, Data Management, R&D, and Regulatory Affairs groups to compile study start up documentation and/or tracking various study documentations.
• Act as department representative/clinical startup leader on project teams.
• As needed, this role may support site qualification, activation, management, and monitoring.
• Knowledgeable in each of the provided areas but also demonstrate a flexible and enthusiastic mindset in establishing new and creative approaches.
• This role will require creative and critical thinking, attention to detail, and a strong ability to prioritize efforts.

Essential Duties and Responsibilities:

Primary Responsibilities (Study Startup Tasks):

• Partner with Program Management, Clinical Science, and Clinical Affairs management to develop and plan clinical studies.
• Write/review protocols, and study reports in consultation with stakeholders (R&D, Biostats, Marketing, etc.), Program Management, Clinical Science, Clinical Trial Lead (CTL), and/or Clinical Affairs Manager.
• Develop clinical study materials (including, but not limited to, source documentation, ICFs, CRFs, IRB submissions, training slides, etc.) under direct supervision of Clinical Trial Lead (CTL) and/or Clinical Affairs Manager.
• In collaboration with Data Management, perform user acceptance testing (UAT) of electronic data capturing (EDC) systems
• Assist with developing monitoring plan and conventions for Sponsor-Investigator and company-sponsored studies.
• Maintain organization, preparation and ordering of supplies and equipment required for clinical studies.
• Draft clinicaltrials.gov submissions.
• Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders.
• Act as a study start up lead for multiple studies/projects simultaneously.
• Clearly demonstrate understanding of clinical study management/prioritization.
• Work independently to manage all clinical tasks and deliverables to meet clinical timeline
• Communicate progress updates to Clinical Trial Lead (CTL), Clinical Affairs management, Program Management, and the various functional groups (R&D, Biostats, Clinical Operations).
• Maintain thorough understanding of clinical regulations and standards (including changing regulations).
• Create and implement regular process improvements.
• This position assumes and performs other duties as assigned.
• Complete tasks under minimal or no direct supervision.

Experience and Education

• Typically requires a Bachelors degree in a technical discipline, and a minimum of 5 plus years related experience or Masters degree and 2 plus years equivalent industry experience or a PhD and 1 plus year of experience.

Required Knowledge/Skills/Abilities:

• Extensive experience in all aspects of clinical trial design and execution
• Minimum of 5-8 years related experience in a medical device, pharmaceutical, IVD, and/or CRO
• Thorough understanding of the processes associated with study preparation and management
• Knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations
• Technical expert in the various aspects of the clinical evaluation process
• Strong interpersonal and communication skills
• Excellent organizational skills and attention to detail
• Ability to manage multiple priorities

Preferred Qualifications:

• Diabetes experience desirable, but not mandatory
• Experienced in the medical device industry, Pharma, BioTech and/or CRO
• Experienced in continuous glucose monitoring (CGM) is a plus
• Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS)

Travel Required:

• The job may require travelling up to 25%-30% of the time as needed; some international travel may be required