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Jeremy Peck
Executive Search Consultant at The Mullings Group
About Us:
Concept Medical is at the forefront of innovative medical device development, dedicated to improving patient outcomes and advancing healthcare solutions. We are seeking a dedicated and detail-oriented Clinical Coordinator to join our dynamic team and support our clinical trial operations.
Job Responsibilities:
Assist in the creation and management of essential clinical trial documents, including CRFs, Informed Consents, Investigator Brochures, SAE reports, and progress summaries.
Manage daily clinical trial operations, ensuring the accomplishment of key clinical milestones such as study enrollment.
Identify, qualify, and initiate clinical sites, ensuring high-quality data collection and conducting quality assurance of data monitoring.
Participate in the preparation and monitoring of clinical study budgets, and contribute to the development of SOPs.
Develop and implement enrollment strategies for clinical trial sites and assist in overcoming site performance hurdles.
Oversee project management performance, including the timely execution of site clinical trial agreements and IRB approvals.
Assist in hiring departmental personnel and train new clinical trial assistants, project managers, and clinical trial monitors.
Manage contract employees such as part-time monitors and vendors for clinical trial services.
Perform other related duties and tasks as required.
Qualifications:
Bachelor’s degree in life sciences, healthcare, or a related field.
Minimum of 3-5 years of experience in clinical research or a related area.
Strong knowledge of FDA regulations, GCP, and ICH guidelines.
Excellent organizational, communication, and interpersonal skills.
Ability to manage multiple projects and meet deadlines.
Proficiency in MS Office Suite and clinical trial management systems (CTMS).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Strategy/Planning, Education, and Health Care Provider
Industries
Medical Equipment Manufacturing
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