Clinical Research Associate
[Marlborough, MA, 01752] | 2025-04-28 19:16:42
Job Description
Job Title: Clinical Research Associate
Location: Marlborough MA
Job Type: Full-Time
About the Role:
We are seeking a uniquely qualified Clinical Research Associate who thrives at the intersection of product management, clinical research, and medical content development. This hybrid role is designed for individuals who bring both a deep understanding of clinical trial processes and a strategic mindset to help shape product direction with scientific integrity and regulatory compliance.
Key Responsibilities:
Collaborate with cross-functional teams to align product development with clinical research goals.
Contribute to the planning, execution, and oversight of clinical studies, ensuring adherence to GCP (Good Clinical Practices) and regulatory requirements.
Provide strategic input on study design, protocol development, and clinical trial documentation.
Liaise with IRBs and regulatory bodies as needed; ensure compliance with all relevant clinical research regulations.
Author and/or review clinical study manuscripts, medical content, and regulatory documentation.
Translate complex clinical data into clear, accurate, and engaging content for internal and external stakeholders.
Act as a subject matter expert in regulatory affairs, clinical research practices, and product positioning from a clinical standpoint.
Required Qualifications:
Certification as a CCRP (Certified Clinical Research Professional) or CCRA (Certified Clinical Research Associate) at least one is mandatory.
GCP certification (Good Clinical Practices) is required.
Proven experience working in clinical research, clinical affairs, or a related regulatory environment.
Strong knowledge of IRB processes, clinical study development, and regulatory compliance.
Experience with medical content development (e.g., clinical manuscripts, protocols, or publications).
Excellent communication skills and the ability to work cross-functionally in a fast-paced environment.
Clinical Research Associate1gcp, Clinical Research, CCRP, CCRA Full TimeUnited States
[Marlborough, MA, 01752] | 2025-04-28 19:16:42
Job Description
Job Title: Clinical Research Associate
Location: Marlborough MA
Job Type: Full-Time
About the Role:
We are seeking a uniquely qualified Clinical Research Associate who thrives at the intersection of product management, clinical research, and medical content development. This hybrid role is designed for individuals who bring both a deep understanding of clinical trial processes and a strategic mindset to help shape product direction with scientific integrity and regulatory compliance.
Key Responsibilities:
Collaborate with cross-functional teams to align product development with clinical research goals.
Contribute to the planning, execution, and oversight of clinical studies, ensuring adherence to GCP (Good Clinical Practices) and regulatory requirements.
Provide strategic input on study design, protocol development, and clinical trial documentation.
Liaise with IRBs and regulatory bodies as needed; ensure compliance with all relevant clinical research regulations.
Author and/or review clinical study manuscripts, medical content, and regulatory documentation.
Translate complex clinical data into clear, accurate, and engaging content for internal and external stakeholders.
Act as a subject matter expert in regulatory affairs, clinical research practices, and product positioning from a clinical standpoint.
Required Qualifications:
Certification as a CCRP (Certified Clinical Research Professional) or CCRA (Certified Clinical Research Associate) at least one is mandatory.
GCP certification (Good Clinical Practices) is required.
Proven experience working in clinical research, clinical affairs, or a related regulatory environment.
Strong knowledge of IRB processes, clinical study development, and regulatory compliance.
Experience with medical content development (e.g., clinical manuscripts, protocols, or publications).
Excellent communication skills and the ability to work cross-functionally in a fast-paced environment.
Clinical Research Associate1gcp, Clinical Research, CCRP, CCRA Full TimeUnited States
Job ID: 475352475
Originally Posted on: 5/1/2025
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