Clinical Site Manager

Summary: 

The Clinical Site Manager is responsible for overseeing performance of the research site activities. Provides on-site oversight to help ensure execution and coordination of clinical research activities visits, documentation and follow up actions according to ICH/FDA guidelines, GCP, and company SOPs, policies and procedures.

Responsibilities:

·        Manage day-to-day operations of clinical research site

·        Ensure compliance with protocols, regulations, and SOPs

·        Coordinate with sponsors, investigators, and participants

·        Supervise site staff and oversee study timelines and budgets

·        Maintain accurate documentation and ensure ethical standards

·        Collaborating with investigators to ensure patient safety and meeting client goals and timelines

·        Employing problem-solving skills to propose and implement risk mitigations

·        Participating and presenting in management or site meetings

·        Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study

·        Perform all other duties as required or assigned.

Qualifications:

• A BS in life sciences preferred or a minimum of an associate’s degree and a minimum of 3 years of management experience in clinical research, or an equivalent combination of education and experience, is required.
• Three or more years of management experience is highly preferred.
• Bilingual (English / Spanish) proficiency is a plus.