Principal Clinical Research Specialist

Leads clinical evaluation research, scientific evidence development, and regulated medical writing for cardiac and electrophysiology products.

Job Requirements

• Advanced medical writing experience

• Experience authoring, editing, critically reviewing, and finalizing scientific and clinical evaluation documents

• Clinical research and clinical evidence development experience

• Experience analyzing complex clinical data and preparing scientifically defensible summaries

• Knowledge of cardiac conditions, electrophysiology procedures, and electrophysiology technologies

• Experience connecting scientific evidence to regulatory, clinical, and commercial requirements

• Experience designing and developing clinical evaluation research studies

• Experience preparing clinical study protocols and patient record forms

• Knowledge of Good Clinical Practice, standard operating procedures, and applicable country-specific clinical regulations

• Experience interpreting clinical investigation results for medical device, drug, or consumer product applications

Preferred Skills

• Experience supporting regulated medical device products

• Experience with cardiac rhythm management or electrophysiology devices

• Experience developing clinical evaluation reports and related regulatory evidence documents

• Experience overseeing registered and nonregistered clinical studies

• Experience supporting clinical trial budgets, clinical supplies, site selection, or vendor selection

• Knowledge of clinical evidence strategies throughout the product lifecycle

Job Responsibilities

• Lead the authoring and critical review of scientific and clinical evaluation documents

• Analyze clinical data and translate findings into clear, accurate, and supportable written summaries

• Ensure clinical documents are scientifically accurate, internally consistent, and aligned with applicable requirements

• Develop and maintain clinical evidence and evaluation documentation

• Provide clinical and scientific input for regulatory, product, and commercial decisions

• Represent clinical functions during cross-functional planning and product-development activities

• Explain the clinical implications of product, regulatory, and business decisions

• Design, plan, and develop clinical evaluation research studies

• Prepare clinical study protocols, patient record forms, and supporting documentation

• Oversee registered and nonregistered clinical studies

• Interpret clinical investigation results for regulatory and product applications

• Oversee clinical trial activities in accordance with SOPs, GCP, and applicable regulations

• Resolve operational issues associated with clinical studies

• Coordinate clinical activities with project teams, research sites, and vendors

• Support clinical trial budgeting, supply operations, site selection, and vendor selection as assigned

• Review scientific evidence for relevance to cardiac and electrophysiology procedures and technologies

Pay: 65-70/hr

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $65.00 to $70.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.