Clinical Specialist II

Clinical Specialist

Pay Rate: $40.00-$42.63 per hour

Location: Remote or Hybrid (Massachusetts)

Job Type: Contract

Project End Date: Q1 2028

Expected Start Date: November 16, 2026

Schedule: 30-40 hours per week, Monday-Friday

Shift: First Shift, 8:00 AM-4:30 PM

Interview Process: One-round panel interview

Position Overview

We are seeking an experienced Clinical Specialist to support clinical safety activities for medical device clinical studies. This role will focus on the collection, review, reconciliation, documentation, and reporting of clinical safety information, including adverse events, serious adverse events, and device deficiencies.

The ideal candidate will have at least three years of clinical safety experience, a strong understanding of clinical trial safety requirements, and experience working with cross-functional teams to support regulatory compliance and patient safety. Experience in interventional cardiology and the medical device industry is highly desirable.

This is a contract opportunity supporting an extended project team, with an anticipated project end date in the first quarter of 2028.

Key Responsibilities

• Collect, review, reconcile, and document adverse events (AEs), serious adverse events (SAEs), device deficiencies, and other clinical safety information from clinical studies.

• Review clinical safety data for completeness, consistency, and potential safety concerns.

• Coordinate follow-up activities with clinical sites and study teams to resolve missing or inconsistent safety information.

• Support safety-event workflows, including medical assessment, event classification, regulatory reporting, and case closure.

• Collaborate with Medical Safety and Medical Affairs teams to facilitate assessments of event seriousness, relatedness, expectedness, and potential device or procedure relationships.

• Prepare and support the submission of safety reports and notifications in accordance with applicable regulatory requirements, clinical study plans, and internal procedures.

• Monitor safety data to identify, document, and escalate potential safety signals and emerging clinical risks.

• Support periodic and aggregate safety reviews, including safety summaries, trend analyses, listings, and performance metrics.

• Reconcile safety information across clinical databases, safety systems, complaint systems, and other relevant data sources.

• Partner with Clinical Operations, Data Management, Regulatory Affairs, Quality, and Medical Affairs to resolve discrepancies and maintain accurate clinical records.

• Support the development and maintenance of clinical safety plans, procedures, work instructions, and study documentation.

• Provide safety-related input for clinical study protocols, case report forms, informed consent materials, clinical study reports, and risk-management documentation, as appropriate.

• Support Data Monitoring Committees, Clinical Events Committees, and other independent review committees when applicable.

• Maintain inspection-ready documentation and assist with internal audits, regulatory inspections, and responses to safety-related inquiries.

• Track safety deliverables, project timelines, and key performance indicators while proactively identifying potential delays or risks.

• Contribute to continuous-improvement initiatives that enhance the quality, consistency, and efficiency of clinical safety processes.

• Maintain current knowledge of applicable medical device regulations, clinical safety standards, Good Clinical Practice (GCP), and relevant regulatory guidance.

Required Qualifications

• Bachelor's degree in Nursing, Life Sciences, Biomedical Sciences, Healthcare, Engineering, or a related discipline.

• At least three years of experience in clinical safety or a related safety-focused role.

• Demonstrated experience supporting clinical trial safety activities.

• Experience managing or coordinating clinical research organizations (CROs).

• Knowledge of U.S. and international regulatory requirements for pre-market and post-market clinical studies.

• Working knowledge of Good Clinical Practice (GCP).

• Strong attention to detail and the ability to evaluate complex clinical information accurately.

• Excellent organizational, analytical, and prioritization skills, with the ability to manage multiple tasks and deadlines.

• Strong written and verbal communication skills.

• Ability to collaborate effectively with cross-functional teams.

• Professional demeanor and commitment to maintaining accurate, compliant clinical documentation.

Preferred Qualifications

• Experience in the medical device industry.

• Therapeutic knowledge or experience in interventional cardiology.

• Experience processing, reviewing, and assessing safety events.

• Experience writing medical narratives and supporting clinical safety assessments.

• Familiarity with German Federal Institute for Drugs and Medical Devices (BfArM) reporting requirements and European Union regulatory safety reporting.

• Experience with clinical trial databases and safety systems, preferably Medidata Rave.

• Knowledge of applicable U.S. and international medical device clinical safety regulations and reporting requirements.

• Fluency in English.

Work Environment and Additional Details

• Work arrangement: Remote or hybrid in Massachusetts.

• Hours: 30-40 hours per week during standard business hours.

• Contract: Project-based opportunity with an anticipated end date in Q1 2028.

• Interview process: One panel interview.

• Dress code: Professional attire.

Work Authorization Requirement

Applicants must be legally authorized to work in the United States without current or future visa sponsorship. Candidates who require visa sponsorship now or in the future cannot be considered for this opportunity.

How to Apply

Qualified candidates with clinical trial safety experience, strong regulatory knowledge, and an interest in supporting medical device clinical studies are encouraged to apply. Experience in interventional cardiology is a plus.

Pay Details: $40.00 to $42.63 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.