ABOUT DERMTECH:

At DermTech, we believe there's a better way to assess skin, and we're using technology, innovation, and data to fundamentally change and enhance precision dermatology. We have developed technology that assesses skin at the RNA and DNA level, so that serious conditions, such as skin cancer, can be detected far earlier, reduce the need for surgery, enable optimized treatment plans, and customize skincare plans to an individual's unique skin molecular makeup. We call this practice “precision dermatology” and we believe it is truly a new era in disease detection. A method that is not just better, but different. One centered around our patented methods, which begins with using our Smart StickerTM to collect tissue from the skin's surface easily, accurately, and painlessly, and follows with our state-of-the-art laboratory, which analyzes that tissue at the genomic level using a proprietary gene analysis system. By pushing the boundaries in precision dermatology and in areas like cancer detection, we truly believe our technology can change the world. We are seeking team members with the vision, passion, and creativity to do the same.

GENERAL DESCRIPTION:

The Clinical Data Assistant (CDA) provides data entry and management support across all clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs. The CDA interacts with cross-functional teams and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Assist with eCRF design and eDC development for clinical trials
• Assist with validation, UAT, and documentation of data capture (EDC) systems
• Assist with development and maintenance of electronic data capture (EDC) systems across multiple studies using various EDC platforms
• Write and maintain clinical data management plans, data transfer agreements, and clinical data flow documents
• Conducts data entry and/or visual verification of data as needed
• Develop study metrics reports as required
• Working with CRAs, assist with reporting and reconciliation of data,
• Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately in a timely manner
• Develops, reviews, and approves study-related manuals, plans, specifications, instructions for use, charters, newsletters, and materials
• Responsible for oversight of site study budget, investigator and vendor contracts,
• Participates in the protocol, table, figure, data listings, and clinical study report reviews

QUALIFICATIONS:

• Bachelor's Degree in Computer Science, Data Science or related science field preferred or equivalent combination of education and experience
• 1+ years related experience in clinical data entry and management.
• Prior experience managing sites entering data, manage query resolution process and working with a CRO ensuring high-quality data
• Experience utilizing CTMS, EDC, TMS, ACCESS, and related software
• Superior organization skills with excellent attention to details
• Strong written and verbal communication skills
• Knowledge of SQL and/or MS Access preferred
• Good computer skills and knowledge of Microsoft Office and the ability to learn appropriate software

ADDITIONAL INFORMATION: An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition. DermTech is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee at DermTech via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of DermTech. No fee will be paid in the event the candidate is hired by DermTech as a result of the referral or through other means.