Clinical Research Associate 2

Responsibilities

• Lead clinical operations activities.
• Manage Clinical study operations (internal and external) in coordination with CRO, IRB, regulatory, and quality teams.
• Support the program sponsor in preparation of clinical study operations.
• Collaborate in the execution of clinical validation studies to support clinical programs.
• Oversee clinical site initiation, monitoring, and closeout activities.
• Participate in Site Monitoring activities.
• Manage CRO partnerships.
• Manage the clinical study biospecimen repository and data management.
• Track Timelines, Milestones, Deliverables, Resources, and Costs.
• Ensure internal and external milestones, deliverables, and obligations are met.
• Partner collaboratively with the Regulatory and Quality teams to ensure that all internal SOPs and compliance documentation meet quality standards.
• Take ownership of key partner-related issues and work with appropriate internal teams to resolve them.

Requirements

• BS or MS in biological science, computer science or a related field.
• Minimum of 2+ years working in industry or academia in clinical operations for medical devices.
• Experienced with products in a clinical or regulated environment (such as with IRB, FDA, CAP/CLIA etc).
• Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) organization and structure.
• Experience with Onsite or Remote clinical study monitoring.
• Experience with Case Report Form (CRF) creation.
• Proficiency in MS Word, Excel, and PowerPoint.
• Experience with Good Clinical Practice (GCP) and clinical quality compliance.
• Demonstrated history of successfully managing multiple concurrent initiatives.
• Strong interpersonal skills, collaboration, and problem-solving with colleagues.
• Strong communication and excellent written and oral skills.
• Detail-oriented, with solid organization and time management skills.
• Able to work under pressure, self-starter, and team player.
• Travel 0-25%.

Desired Experience

• 3+ years working in industry or academia in clinical operations for medical devices.
• 2+ years program management experience
• Experienced with products for ex-US regulatory agencies (EU, Japan, Australis etc).
• Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) setup and validation.
• Experience Metadata Statistical analysis.

Pay

The hiring range for this position is $120,000 to $145,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors.

Schedule

Days Onsite: Monday & Tuesday (Hybrid)