Research Project Coordinator

$58,240 - $68,640/Yr

Insperity - Central LA, CA

Full-time

Central LA, CA

Professional, Scientific, and Technical Services

About the position

The Research Project Coordinator at ONCOTherapeutics plays a crucial role in supporting the planning, organization, and execution of clinical research studies focused on oncology. This position involves ensuring compliance with regulatory requirements and institutional guidelines while managing various aspects of clinical trials, including site recruitment, vendor coordination, data management, and regulatory compliance. The ideal candidate will be detail-oriented, organized, and capable of working both independently and collaboratively within a team.

Responsibilities

• Assist in the planning and executing of clinical trials, ensuring adherence to study protocols, timelines, and budgets.
• Collaborate with project managers to facilitate smooth project execution and address any operational issues.
• Support the recruitment of study sites by coordinating with potential sites and managing communications.
• Assist in evaluating and selecting sites based on their capabilities and suitability for the study.
• Facilitate site initiation activities, including site qualification visits, investigator meetings, and contract negotiations.
• Monitor site performance, ensuring adherence to protocol and addressing any issues.
• Provide ongoing support to sites, including resolving operational challenges and ensuring compliance with study requirements.
• Coordinate with pharmaceutical and external vendors to procure and distribute study materials.
• Oversee the management of study kit supplies, including inventory control and distribution to study sites.
• Support collecting and verifying clinical trial data, ensuring accuracy and consistency.
• Input, manage, and maintain data within appropriate databases or data management platforms, ensuring accuracy and confidentiality.
• Assist in developing reports, manuscripts, and presentations based on the gathered data.
• Prepare and submit regulatory documents to institutional review boards (IRB) or other governing bodies.
• Ensure study compliance with federal, state, and institutional regulations and standards throughout the project lifecycle.
• Maintain strict patient confidentiality according to HIPAA regulations, GCP, and ICH, 21 CFR.
• Schedule, attend, and record minutes from team meetings, ensuring prompt follow-up on tasks and action items.
• Utilize Excel, Slack, Google Drive, and Salesforce-based CTMS tools for effective communication, data storage, and progress tracking.
• Stay informed about industry trends, regulatory changes, and best practices in clinical research by participating in relevant workshops, conferences, and seminars.

Requirements

• Bachelor's degree in a relevant domain (e.g., Public Health, Life Sciences, or similar) is preferred or equivalent and relevant experience.
• Solid organizational skills and attention to detail.
• Familiarity with platforms like Slack, Google Drive, clinical trial management systems (CTMS), data management platforms, and Salesforce.
• Proficiency in both written and verbal communication.
• Ability to operate both autonomously and collaboratively within a team.
• Proven capability to manage multiple tasks and projects effectively.
• Must obtain Good Clinical Practice (GCP) & Human Subject Research (HSR) within 90 days of hire date.

Benefits

• Comprehensive health coverage: Medical, dental, and vision insurance
• 401(k) plan with employer matching
• Life and disability insurance
• Flexible spending and health savings accounts
• Generous paid time off and holidays
• Employee assistance program