Clinical Data Specialist Jobs in North Carolina

What We Offer:

This position is responsible for securely managing information systems throughout their lifecycle, including; knowing what information systems are within their scope of responsibility, understanding what sensitive data is stored, transmitted, or processed on those information systems, enforcing the security principles of least privilege and least functionality, knowing what events may constitute an information security incident, and understanding their role in security incident response activities.

The Clinical Research Application Analyst II will be responsible for administering established clinical research information systems such as the Clinical Trial Management System (CTMS), e-Regulatory platform, interoperability with the health system Electronic Medical Record (EMR) system, electronic signature platforms, provider and consumer-facing research portal interfaces, various internal and external research databases/registries, investigational pharmacy platforms and other systems as required. Regular activities include, but are not limited to, the following: monitoring of clinical research software; troubleshooting and reporting software issues; supporting end-users; supporting software upgrades, managing configuration of software; assisting with implementation of new processes; organizing and maintaining the electronic Trial Master File (eTMF); and liaising with Digital Products and Services (DPS) to support clinical research conduct in information systems. The Clinical Research Application Analyst will support and administer future technologies as required.

Education:

4 Year / Bachelors Degree, preferred.

Experience:

- 2 years clinical research experience, required.
- 4 years clinical research experience, preferred.
- 2 years CTMS, e-regulatory experience, required.
- Awareness and understanding of HIPAA, GCP and clinical research regulations as they apply to healthcare informatics, required.
- Experience implementing a new IT application or service, preferred.

Licensure/Certification:

- Certification in applicable technologies (OnCore, Epic, Business Analytics), required.
- CITI, required.
- SOCRA, ACRP, or other research certification, preferred.

Additional Skills/Requirements (required):

- Proficient with following established workflows and knowledge of application product function.
- Strong analytical skills for problem resolution and support of the application product.
- Proficient in ITS processes to include but not limited to analysis, testing, and change control.
- Ability to drive/travel to multiple locations/facilities as needed and interact with team members virtually.
- Knowledge of research operations including study startup, financials, reporting requirements, and closeout.
- Works with a high degree of independence, using discretion and independent judgment in the execution of tasks.
- Understanding of how business requirements relate to clinical research software.

Additional Skills/Requirements (preferred):

- Demonstrated ability to effectively train and provide feedback to team members.
- Awareness of database query and business report design.
- Understanding of application infrastructure design.