POSITION: LEAD CLINICAL RESEARCH COORDINATOR

Responsibilities

1. Study Coordination

- Work closely with principal investigators to plan and execute clinical research studies.

- Ensure compliance with study protocols, regulatory guidelines, and ethical standards.

- Coordinate study activities, including participant recruitment, enrollment, and retention.

- Schedule participant visits and coordinate study procedures.

2. Participant Management

- Screen and recruit eligible participants according to study criteria.

- Obtain informed consent from participants and ensure understanding of study procedures.

- Provide support and guidance to participants throughout the study duration.

- Coordinate participant follow-up visits and assessments.

3. Data Management

- Collect, record, and maintain accurate and complete study data.

- Enter data into study databases or electronic data capture systems.

- Ensure data quality and integrity through regular monitoring and verification.

4. Regulatory Compliance

- Assist with preparation and submission of regulatory documents, such as Institutional Review Board (IRB) applications and informed consent forms.

- Maintain study documentation and regulatory files in accordance with regulatory requirements.

- Monitor and ensure compliance with Good Clinical Practice (GCP) guidelines and applicable regulations.

5. Communication and Collaboration

- Serve as a liaison between study sponsors, investigators, research staff, and participants.

- Coordinate communication and meetings with study team members and stakeholders.

- Collaborate with interdisciplinary teams to resolve study-related issues and challenges.

6. Administrative Tasks

- Assist with budgeting, financial tracking, and procurement related to study activities.

- Prepare and maintain study-related documentation, including study manuals, SOPs, and training materials.

- Coordinate study logistics, such as equipment and supplies procurement.

Qualifications

- Previous experience in oncology clinical research coordination.

- Knowledge of clinical research regulations, GCP guidelines, and ethical principles.

- Strong organizational skills and attention to detail.

- Excellent communication and interpersonal skills.

- Proficiency in computer applications, including MS Office and electronic data capture systems.

- Ability to work independently and as part of a team in a fast-paced environment.

- Certification in clinical research (e.g., ACRP, SOCRA) desirable but not required.

Additional Requirements

- Willingness to adhere to strict confidentiality requirements.

- Flexibility to work occasional evenings or weekends, depending on study requirements.

- Ability to travel to off-site locations for participant visits or study-related meetings, if necessary.