Clinical Research Specialist

Clinical Research Specialist Overview

• The Clinical Research Specialist role involves supporting clinical studies, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements.
• Contribute to the planning and execution of clinical research studies, including site management and coordination with stakeholders.
• Assist in study documentation, data review, and maintaining clinical systems for operational efficiency.
• Work under the guidance of a Clinical Study Manager to achieve study objectives and milestones.
• Support study start-up and closeout activities, ensuring proper documentation and compliance.
• Collaborate with internal and external teams to drive successful clinical trial outcomes.
• Opportunity for contract extension or conversion to permanent position based on performance.

Clinical Research Specialist Key Responsibilities & Duties

• Design, plan, and oversee clinical evaluation research studies, ensuring adherence to protocols and regulations.
• Prepare and author study protocols, patient record forms, and regulatory documentation.
• Conduct clinical studies, analyzing results for medical device applications and regulatory submissions.
• Manage site and vendor selection, ensuring operational efficiency and compliance.
• Coordinate with project teams to resolve operational aspects of clinical trials.
• Maintain clinical systems and documentation, ensuring accessibility and accuracy.
• Provide mentorship to junior professionals, fostering professional growth and collaboration.

Clinical Research Specialist Job Requirements

• Bachelor’s degree in science or related field required; advanced education preferred.
• Minimum of 1-2 years of experience in clinical research or related field.
• Proficiency in clinical systems such as CTMS, EDC, and TMF.
• Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
• Experience in site management and coordination with internal and external stakeholders.
• Ability to work independently with general supervision on complex projects.
• Excellent communication and organizational skills for effective collaboration.