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 Trial Assistant (CTA) provides oversight of clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs. The CTA participates in 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:

• QC oversight of CRO, TMF documents
• Process and track payments to vendors and study sites as appropriate
• Support VP of Clinical Research, Sr. Director of Clin-Operations,  Study Managers and CRAs in all aspects of the conduct of Clinical Research Trial from site identification through closeout/CSR generation
• Ability to maintain multiple tracking systems related to study details, training, and trial metrics
• Lead sample accessioning efforts as needed
• Print, assemble and ship start-up materials to investigator sites as needed
• Track and ship trial equipment if required
• Receive and track returned equipment if required
• Assist with budget and contract processing, support clinical research managers in sending/processing budget and contract materials
• Assist with site feasibility activities/non-disclosure agreements
• Assist with collection of regulatory documents
• Create and generate study relevant updates/reports through spreadsheets
• File documents within the TMF/eTMF
• Distribute study plans and correspondence to relevant team members
• Distribute and track correspondence to investigator sites and study vendors
• Schedule/coordinate in-house and off-site meetings and training sessions
• Attend study team meetings, produce and distribute meeting agenda and minutes 
• Participate in data cleaning, listing, and report output reviews

EDUCATION/EXPERIENCE/SKILLS:

• Bachelor's Degree in life science or equivalent combination of education and experience
• 2+ years experience in a Clinical Research related role within the pharmaceutical/biotech or CRO industry
• Experience with diagnostics, Laboratory Developed Tests preferred
• Previous clinical work experience that provides the knowledge, skills, and abilities to perform the job
• Experience utilizing CTMS, EDC and related software
• Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay preferred
• Excellent written and verbal communication skills
• Ability to multi-task and re-prioritize workflow as necessary
• Proficient knowledge of Microsoft Office Suite and the ability to learn additional necessary 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.