"Intake and Activation Assistant"

Job Details

Advertising Summary: Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer.
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Unit: School Of Medicine MBU

Department: Clinical Research Office

Duties & Responsibilities:

The VCU School of Medicine Clinical Research Office (SOMCRO) is seeking candidates for hourly intake and activation assistant(s). This entry-level position is designed for individuals interested in gaining experience in clinical research administration, operations, and budgeting while working closely with our lead intake coordinator, program manager, budget project managers, and operations teams.

SOM is committed to supporting VCU clinical researchers in advancing medical science in our region. The Intake and Activation Assistant is responsible for coordinating clinical research intake in a compliant and efficient manner. They will collaborate with all members of the clinical research team to ensure expedited processing of intakes and amendments.

This is an hourly (<29 hours/week), non-benefited position that offers an opportunity to learn study procedures, build foundational skills in clinical research, and contribute to the success of VCU School of Medicine's research enterprise. Successful candidates who demonstrate their value to the team may have the opportunity to transition into benefited positions within the next 6–12 months, as our program continues to grow.

This position will support human subject research by facilitating the flow of study documents within SOMCRO and assisting with administrative tasks. It requires the ability to work independently and as a key member of our team. The intake and activation assistant is expected to work under general supervision, resolving most standard issues independently, and referring complex issues to upper-level management. The intake and activation assistant will support SOM clinical investigators with activation and management of clinical trials budget intake in a positive and dynamic environment, with specific emphasis on processing protocol amendments.

This position reports to the SOMCRO Operations Program Manager, where key responsibilities include:

Responsibility 1 (20%): Accountability and excellence in customer service.

• Serve as liaison and partner between principal investigators, research groups, and departments.
• Collaborate with coordinators, project managers, and sponsors to triage study-specific questions and facilitate timely resolution.
• Promote accountability by maintaining clear documentation of internal SOPs and working guidance, as well as providing clear communications to our investigators and study sponsors.
• Understand the importance of ownership of tasks and responsibilities.
• Grow relationships with investigators and sponsors by developing trust and delivering on services.
• Provide timely and courteous responses to queries from study teams, faculty, and sponsors.
• Develop relationships with members of the study teams, departmental personnel, colleagues, and co-workers throughout VCU and VCUHS.
• Communicate with clinical trial sponsors as appropriate, e.g., study activation responsibilities, essential document collection, and ongoing coordination.

Responsibility 2 (40%): Coordinate administrative duties for study amendments

• Support study administration processes for amendments
• Implement tools and reporting to improve activation and amendment processing timelines
• Support Program Manager in documentation of SOMCRO activation processes and procedures
• Facilitate routing of important clinical research documents to appropriate analysts for study activation and project management.
• Review amendments, request documents, facilitate processing for budget and calendar changes.

Responsibility 3 (20%): Coordinate Clinical Research Intake and Workflow

• Coordinate clinical research intake, activation, and amendment workflows to ensure completeness, compliance, and alignment with SOMCRO processes.
• Manage and review intake and submission documentation, including feasibility and PROC.
• Serve as the primary liaison for communication related to new studies and activation.
• Ensure accurate study record initiation (FP creation in SPOT) across OnCore and RAMS SPOT.
• Oversee study workflow transparency by coordinating with the operations and budget teams.
• Maintain intake and “Not Ready to Activate” tracking and support resolution of outstanding items.
• Establish and maintain organized study files and distribute requests to appropriate teams.

Responsibility 4 (20%): Support SOMCRO teams with study tasks and communications

• Work with SOMCRO administrative activation team by providing support and valuable input.
• Participate in the routing of the budget feasibility process for clinical research amendments.
• Assist with maintaining accurate and updated Standard Operating Procedures.
• Coordinate working meetings with study teams and key stakeholders as needed.
• Assist with special projects as needed.
• Assist with managing the shared drive.

Qualifications:

Minimum Qualifications

• Degree in health sciences, administration, or business-related field or 1-3 years clinical research and/or administrative experience in lieu of degree.
• Excellent communication, writing, and interpersonal skills.
• Exhibits professionalism and ability to work independently and collaboratively.
• Excellent organization, time management, and critical thinking skills including attention to detail.
• Familiar with Microsoft operating systems including email, word, excel and PowerPoint.
• Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from various backgrounds and experiences, or a commitment to do so as a staff member at VCU.

Preferred Qualifications

• Completion of research ethics training (CITI)
• Experience with clinical research
• Previous experience with Oncore or RAMS systems
• Experience in a healthcare or research setting
• Familiarity with VCU or VCU Health preferred

Salary Range: $16.00 - $22.00/hr

Benefits: All VCU employee types are eligible for a wide array of benefits to support you during your employment at VCU. Consult the benefits website for information on benefits eligibility according to employee type.

FLSA Exemption Status: Non-Exempt

Flexible Work Arrangement: Hybrid