Senior Clinical Research Associate
Senior Clinical Research Associate
The Mullings Group
New York City Metropolitan Area
See who The Mullings Group has hired for this role
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 individual 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).
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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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