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.