Senior Data Coordinator

Employment Type: Permanent Staff (SHRA)

Vacancy ID: P012231

Salary Range: $42,623 -$50,145

Position Summary/Description:

WHEN APPLYING TO THIS POSTING YOU WILL BE APPLYING FOR THE FOLLOWING FIVE POSITIONS: 20037585, 20037586, 20037587, 20037588 AND 20037589.

THIS IS A TIME LIMITED POSITION, WITH AN ESTIMATED DURATION OF ONE (1) YEAR.

The Senior Data Coordinator is an expert in their assigned studies and is, therefore, a resource to other site staff for questions or concerns regarding these studies. They work closely with the clinical, regulatory, and lab staff to make sure that the collection and reporting of study data are being conducted appropriately and efficiently. They conduct ongoing training with site staff to ensure that data-related processes are being followed correctly. They manage the creation and maintenance of protocol-specific source documents., which are the primary source of research data collected for all study participants. They also oversee quality and data management for their assigned studies. This involves a nuanced review of completed source documents to ensure that Clinical Research Coordinators have appropriately collected participant study data per protocol requirements. The Senior Data Coordinator also abstracts the clinical data from the completed source documents and enters this into the study sponsor's clinical database. This involves in-depth knowledge of the study's reporting requirements since the data they report is used for the study's statistical analysis. The Senior Data Coordinator also serves as a primary liaison with the study sponsor's Monitors. The Monitors review the data collected by our site via both in-person and remote methods. The Senior Data Coordinator works closely with the Monitors to ensure that the questions they raise are resolved. After a Monitoring visit, they ensure that any corrective actions or staff re-training are done appropriately.

All activities are done in accordance with Federal, State, and local regulations, as well as Good Clinical Practice (GCP). The Senior Data Coordinator works as part of a team and supports the Investigators of Record, Clinical Research Coordinators, and other research team members in their work. This position is critical to study implementation and assists with data management activities associated with our studies. Poor data documentation of research activities can endanger the clinical well-being of study participants and cause unanticipated adverse events. Ineffective data management activities can result in for-cause audits by either the study sponsor or the FDA. Data performance is also a key component of sponsor evaluation for the study awards and allows the unit to successfully compete for new funding.

Education and Experience:

Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Essential Skills:

The selected candidate must be detail-oriented and conscientious; able to meticulously perform all study-related functions. They must be able to demonstrate a professional demeanor and excellent communication skills and be able to effectively work with people from diverse backgrounds. The person in this position must have the ability to multitask and reorganize tasks according to shifting priorities.

Preferred :

Familiarity with HIV, COVID-19, clinical research, or database experience helpful.

AA/EEO Statement:

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.