What are the responsibilities and job description for the CTMS Designer position at Pinnacle Clinical Research?
Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare.
Summary :
CTMS designer is responsible for enforcing policies and procedures for gathering and creating accurate and compliant eSource. They will be responsible for creating, execution and managing eSource at multiple site locations. They will also be responsible for coordinating with the data management team for eSource creation, execution, and management. This position will also be responsible for providing insight into the development of eSource processes and SOPs, while contributing to strategic decisions affecting their functional responsibilities. They will also be responsible for meeting site / sponsor / vendor data eSource requirements and ensure eSource compliance with GCP / ICH and FDA requirements. The ideal candidate will be responsive, analytical, thoughtful, self-motivated, highly organized, detail-oriented and a team-player.
Duties and Responsibilities :
- Maintain subject and document confidentiality at all times, understand and comply with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, Good Clinical Practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
- Responsible for creating esource for document capture within site’s CTMS (CRIO) system.
- Responsible for the oversight of CTMS (CRIO) as it relates to esource and data management which is essential for daily business operations
- Collaborate with internal site staff and external personnel such as physicians, nurses, administration, industry sponsor representatives to ensure accurate eSource creation and management.
- Coordinate multiple complex projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume at multiple PCR locations.
- Responsible for the integrity of the eSource and updates version control when eSource or study documents are revised.
- Responsible for the maintenance systems necessary for document and esource version control.
- Responsible for document accuracy and security and for removing obsolete documents.
- Will lead meetings applicable to eSource
- Ensures applicable staff approve documents prior to publishing for use.
Education / Experience :
Knowledge, Skills, and Other Abilities :
Work Environment and Physical demands :
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Perks of working at Pinnacle Clinical Research :
Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State / Province or Local status unrelated to the performance of the work involved.
About Pinnacle Clinical Research :
At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare.
