Job Description

Job Description

Job Description

Lighthouse Lab Services has partnered with an innovated research lab dedicated to advancing medical knowledge and improving patient care in Miami, FL and beyond. We're seeking a talented and experienced Senior Clinical Research Coordinator to lead our research initiatives and drive excellence in clinical trial management.

Job Summary:

The successful candidate will play a key role in the planning, coordination, and execution of clinical research studies across a variety of therapeutic areas. Working closely with investigators, sponsors, and regulatory agencies, you'll ensure compliance with study protocols, regulatory requirements, and ethical standards while fostering a culture of collaboration and excellence within the research team.

Key Responsibilities:

Study Coordination and Management:

• Oversee the planning, implementation, and management of clinical research studies.
• Develop and maintain study protocols, informed consent documents, and other regulatory documents.
• Ensure compliance with Good Clinical Practice (GCP) guidelines, FDA regulations, and institutional policies.

Participant Recruitment and Retention:

• Develop and implement strategies for participant recruitment, screening, and enrollment.
• Monitor participant adherence to study protocols and manage follow-up visits.
• Address and resolve any issues related to participant retention and compliance.

Data Management and Reporting:

• Ensure accurate and timely data collection, entry, and management in electronic data capture (EDC) systems.
• Perform regular quality checks to ensure data integrity and resolve any discrepancies.
• Prepare and submit study progress reports, adverse event reports, and other required documentation to regulatory bodies and sponsors.

Regulatory Compliance and Documentation:

• Maintain up-to-date regulatory binders and essential documents.
• Coordinate and participate in audits and monitoring visits by regulatory agencies and study sponsors.
• Ensure timely submission of Institutional Review Board (IRB) applications, amendments, and continuing reviews.

Team Leadership and Training:

• Provide training and mentorship to junior research staff and new team members.
• Delegate tasks and responsibilities appropriately to ensure efficient workflow.
• Foster a collaborative and positive work environment.

Communication and Collaboration:

• Serve as the primary point of contact for study sponsors, investigators, and regulatory agencies.
• Facilitate communication between study team members, clinical staff, and other departments.
• Participate in study team meetings and provide updates on study progress and challenges.

Qualifications:

• Bachelor's degree in a related field.
• Master's degree or higher preferred.
• Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) preferred.
• Minimum of 5 years of experience in clinical research, with at least 2 years in a senior or supervisory role.
• In-depth knowledge of clinical trial processes, regulatory requirements, and GCP guidelines.
• Proficiency in using EDC systems and other clinical research software.
• Excellent organizational and time management skills.
• Strong leadership and team-building abilities.
• Exceptional attention to detail and problem-solving skills.
• Excellent communication and interpersonal skills.

Shift and Salary:

• Monday - Friday
• 8:00am - 5:00pm (hours may vary)
• $31.00 - $41.00/hour

About Us:

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 20 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.

Lighthouse Lab Services | 800-838-0602 |

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Job Tags

Permanent employment, Local area, Shift work, Monday to Friday,

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