READING CENTER PROJECT MGR.

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

Occupational Summary 

This position will report to the Administrative Manager and will assist the Project Manager with a variety of duties to support the Duke Reading Center. 

 

Work Schedule 

Regular, full-time 40 hours/52 week position. 

 

Position Summary 

 

The Project Manager Assistant (PMA) performs a variety of research and administrative duties to support the management of clinical trials at the Duke Reading Center (DRC). They perform a variety of independent duties involved in the collection, documentation, and compilation of clinical research images and data under the direction of the Project Manager. The PMA assists with assigning reader grading tasks, filing study documents, distributing site initiation forms, tracking certification of site technicians, and tracking submission of images and functional tests for grading. They also assist with queries, data entry (DE), source document verification (SDV), and quality control (QC) activities such as reconciliation and reconciliation verification (RV). 

 

Responsibilities 

• Communicate with sites, sponsors, and CRO’s regarding study specifics and image issues 

• Assist with study startup and site certification activities 

• Track, confirm, and document receipt of all images and functional test materials received at DRC 

• Manage certification reader assignments and assist with all other reader assignments as needed 

• Respond to data queries as appropriate 

• Prepare materials for and perform data QC Review, i.e. reconciliation and reconciliation verification 

• Perform data entry (DE), source document verification (SDV), filing and other clerical duties as requested 

• Assist all DRC staff members as necessary to meet the needs of the various studies 

• Attend DRC group meetings as needed 

• Provides coverage for assigned studies when PM is out of the office or unavailable. This may include time sensitive activities such as patient screening eligibilities and sponsor requests 

• Assist with training of new PMA’s 

 

Education/Training 

 

1. Completion of a Bachelor’s Degree in a related field. At least one year of directly related experience in clinical research is preferred. 

 

Knowledge, Skills, and Abilities 

 

· Excellent oral and written communication 

· Capable of exercising good judgment 

· Ability to be flexible when priorities change 

· Ability to deal with a variety of constituents efficiently 

· Ability to learn new programs quickly 

· Organizational skills 

· Ability to work under deadline pressure 

· Ability to prioritize work assignments 

· Ability to be flexible when work assignments change 

· Enjoys and can effectively multitask 

· Excellent knowledge of Microsoft Excel and Outlook

Level Characteristics

Project Manager Assistant (PMA) Duties Interact with clinical study sites regarding image materials issues Assist with study startup, site certification activities Serve as backup liaison between the Duke Reading Center and the study sites Serve as backup liaison with study sponsor and CRO as appropriate Assist with data transfers to the study sponsor Attend conference calls with study sponsors Perform routine correspondence with sites, sponsors, and CROs Confirm receipt of all image materials received at the Duke Reading Center Respond to data queries as appropriate Prepare materials for grading and arbitration Perform data entry, filing, and other clerical duties Assist all Duke Reading Center staff members as necessary to meet the needs of the various studies Attend Duke Reading Center group meetings as needed Level I Project Manager Duties Interact with clinical study sites r