Research Trial Intake Coordinator

Summary:

The Trial Intake Coordinator manages the initial stages of clinical studies ensuring that centralized start-up activities proceed smoothly and efficiently. This role involves evaluating new requests for services and coordinating with internal teams within the Center for Clinical Research Management and various research departments as well as with external contractors and study sponsors. The coordinator facilitates the establishment of trial infrastructure and serves as a liaison between investigators or their research staff and the companies contracted to provide outsourced centralized research services. The ideal candidate will have strong organizational skills attention to detail and the ability to manage multiple tasks effectively in a fast-paced environment.

Responsibilities:

• Protocol Intake Management: Oversee all aspects of the intake process for new clinical research studies using multiple electronic platforms. Inform relevant stakeholders within the Center for Clinical Research Management office about any service requests that extend beyond the standard core services.

Evaluates each new study protocol independently to identify the necessary institutional documentation such as letters of cooperation radiation safety officer consultations DNA/biosafety committee reviews investigational drug services etc. required to fulfill the services requested.

Documentation Handling: Oversee the collection organization and distribution of essential trial documents including protocols informed consent forms sponsor budgets and any regulatory documents related to central services. Secure letters of cooperation from both internal and external departments involved in the research study. The trial intake coordinator will handle gathering all necessary documentation for the institutional review board (IRB) the clinical trials office (CTO) and other relevant departments and ensure that this information is forwarded to key stakeholders involved in the studys start-up process.

Stakeholder Communication: Serve as the primary liaison between research departments sub-departments within the Center for Clinical Research Management office external contractors and other internal departments. Address inquiries and ensure effective communication to facilitate a seamless trial intake and start-up process.

• Data Management: Creates protocol shells for each new study in the clinical trial management system (CTMS). Maintains accurate records of trial intake activities in the electronic data management system(s) ensuring data integrity and confidentiality.

Study Start-up Coordination: Communicate effectively with research departments to provide updates on the progress of each study throughout the intake and start-up process. Request contracted outsourced services from external vendors on behalf of research departments. Review negotiated budgets and Medicare Coverage Analyses (MCA) to ensure they comply with federal and state regulations as well as institutional specifications and policies related to clinical trial billing as applicable.

Process Improvement: Identify opportunities for process enhancements and participate in the development and implementation of best practices for trial intake procedures. Maintain records of QA findings on all outsourced services. Attend QA meetings with external vendors as required by management.

• Training and Support: Provide support to new staff and stakeholders on intake procedures and system usage. Offer guidance on protocol submission and documentation requirements to investigators and their research staff.
• Reporting: Generate and maintain reports on intake activities protocol status and other relevant metrics as required by management.
• Additional Responsibilities
• Revise non-outsourced MCA to align with protocol amendments.

o Revise non-outsourced calendar builds in the Clinical Trial Management System (CTMS) to align with revised sponsor protocols.

• Negotiate non-outsourced sponsor budget revisions as appropriate.

Other information:

EXPERIENCE:

• Education: Bachelors degree in Life Sciences Healthcare Administration or a related field.
• Experience: Minimum of 2 years of experience in clinical trials clinical research administration or a related field. Experience with protocol intake and study start-up process a plus.
• Skills:
• Strong organizational and multitasking abilities.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word Excel PowerPoint) and electronic data management systems; CTMS experience required OnCore experience preferred; REDCap experience a plus.
• Attention to detail and accuracy in handling documentation.
• Ability to work independently and as part of a team.
• Attributes:
• High level of professionalism and confidentiality.
• Problem-solving mindset with a proactive approach to challenges.
• Adaptability to a dynamic work environment.
• Supervisory responsibility:

Brown University Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status.   Brown University Health is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union