CLINICAL TRIALS ASSISTANT MANAGER

Institute for Medical Research

Clinical Trials Assistant Manager

Durham, NC 27701

Institute for Medical Research at the Durham VA Health Care System

CLINICAL TRIALS ASSISTANT MANAGER

PI : Dr. Stephen Freedland

The Clinical Trials Assistant Manager is involved with overseeing data abstraction and entry, specimen handling, and tracking recruitment for research studies conducted by the Principal Investigator, Dr.

Stephen Freedland, in his urology and oncology research lab. This includes training and supervising study personnel involved in data abstraction and entry, screening & consenting of patients, monitoring progress of projects, contributing to project planning, and creation and maintenance of SOPs.

These multiple functions require a significant degree of flexibility and independence to complete complex tasks.

In this position, you will work with a highly productive and dynamic team of MDs, PhDs, and research scientists at a high-tier medical institution.

The Clinical Trials Assistant Manager will continue to gain considerable knowledge of clinical research methods, cancer biology, and urology.

The Clinical Trials Assistant Manager may have the opportunity to shadow in the OR, attend seminars, and engage in other learning opportunities such as manuscript writing.

This position is supervised by the National Prospective Clinical Research Coordinator.

Responsibilities include, but are not limited to the following :

Critical Element 1 : Assist with CTA-related administrative tasks.

• Help to hire clinical trials assistants
• Supervise 4-8 clinical trials assistants
• Approve timecards, conduct performance reviews, troubleshoot technical problems, maintain calendars, respond to procedural questions
• Coordinate staff learning experiences
• Adhere to safety, privacy, and compliance regulations

Critical Element 2 : Train and supervise CTAs completing data abstraction, recruitment, and sample processing.

• Create and update training materials
• Lead lab and project-specific training sessions
• Teach study personnel how to conduct data abstraction and entry into electronic databases
• Teach study personnel how to complete interest and consent activities
• Teach study personnel how to process samples

Critical Element 3 : Monitor project progression through data entry, sample collection, and study recruitment for select projects.

• Coordinate project workflow to ensure projects are executed properly
• Monitor team reviews and answer questions from clinical trials assistants about study procedures
• Ensure data queries are resolved in a timely manner
• Assist with sample shipping and processing
• Update team meeting agendas to reflect abstraction and recruitment progress
• Assist in establishing appropriate timelines for completing study-related activities
• Maintain patient confidentiality

Critical Element 4 : Document and modify standard operating procedures for select projects.

• Maintain meeting notes and agendas
• Recommend new methods for collection and documentation of data
• Maintain, modify, and create SOPs and reference guides for select projects

Critical Element 5 : Provide insights, opinions, and data to supervisors for project planning.

• Participate in regular planning meetings with team members
• Provide status updates and estimates related to scheduling and work capacity to National Prospective Clinical Research Coordinator
• Prepare and maintain written copies of electronic records for rapid access
• Work effectively as part of a team

Non-critical Elements

• Review electronic medical records for medical data and enter into electronic databases.
• Spend 20% effort on other projects that benefit the group

Supervisory Controls

The Clinical Research Coordinator supervises the Clinical Trials Assistant Manager. The incumbent is expected to meet deadlines on routine duties and to use his / her own initiative in completing work.

Work may be reviewed by any member of the principal investigators research team.

Qualifications / Experience :

This position requires an organized, task oriented, deadline-sensitive individual with a Bachelors degree and one year of relevant experience.

Applicants must deal diplomatically and professionally with administration, faculty, clinical and lab personnel, and subjects.

Demonstrated leadership, professional initiative and teamwork abilities are required. Basic computer skills are required, with experience using MS Access and MS Excel preferred.

This position requires an applicant who has at least one year of experience with data abstraction and study enrollment procedures.

Prior experience with FDA regulations and HIPAA considerations is preferred.

Candidates must be available to work in-office Monday-Friday. The rate of pay is $23.50 per hour.

Applicants must have the ability to : work independently in a fast-paced environment, prioritize and manage the workflow of multiple projects, sit for long periods in front of computers, lift up to 40 pounds, bend and reach in order to locate specimens in deep freezers, communicate effectively via phone and email, and be fluent in English.

Applicants must be comfortable working with human specimens including, but not limited to, blood, urine, stool, and saliva.

The prior statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.

Employees may be directed to perform job-related tasks other than those specifically presented in this description.

IMR offers a competitive benefits package which includes health insurance, a matching 403b retirement savings plan, and paid holiday, vacation, and sick leave.

All IMR employees are required to obtain a WOC appointment at the DVAHCS. As a result, the successful candidate must undergo a federal background check and may be subject to a drug test.

IMR employees must reside in the state of North Carolina. We will not sponsor applicants for work visas.

Participation in the seasonal influenza and Coronavirus Disease 2019 (COVID-19) Vaccination programs may be required for a Department of Veterans Affairs Health Care Workers Without Compensation (WOC) appointment.

We are an equal-opportunity employer, including disabled persons and Veterans.