Clinical Data Specialist/Spec 1, Clinical Data at Spectraforce Technologies

Title: Clinical Data Specialist/Spec 1, Clinical Data
Location: Remote - U.S, Locum / Per Diem (up to 20 hours per week.)
Duration: 6 months


Position Summary:
The purpose of the Clinical Data Specialist position is to support the design, build and maintenance of EDC systems for Client APM clinical studies, ensuring data accuracy and regulatory compliance. Key responsibilities include creating eCRFs (electronic Case Report Forms), creating database specifications, guiding database design and edit check definitions, user acceptance testing, support with creating and verification of case report form completion guidelines.

Key Responsibilities:

• Design and create electronic case report forms in support of EDC system builds
• Develop and implement edit checks, data entry guidelines, and validation rules.
• Perform user acceptance testing (UAT) and system validation.
• Work closely with clinical teams to understand study requirements.
• Provide training and support to site staff and internal users on EDC systems.

Education and Experience:

• Prior experience as a clinical project manager, data manager, or similar position with daily responsibilities for electronic clinical study databases required.
• Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional need
• 3 or more years of relevant clinical research experience in the device industry
• Medical Device experience preferred

Knowledge and Skills:

• Fluent knowledge of spoken and written English language, including medical terminology
• Superior written and verbal communication skills
• Proficiency in presentation preparation and delivery
• Technical savviness with an ability to understand the impact technology has on increasing effectiveness and performance
• Working knowledge of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.
• Working knowledge of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPPA
• Ability to work in and promote team cohesiveness in a virtual/remote environment
• Demonstrated ability to prioritize multiple tasks with competing timelines and deliverables