Clinical Research Associate Ii

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 Research Associate II will perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support the start-up phase.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting the development of project subject recruitment plan on a per-site basis.
• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• If applicable, may be accountable for site financial management according to an executed clinical trial agreement and retrieve invoices according to local requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Escalate quality issues as appropriate.

Qualifications

• Years of independent monitoring experience within a Contract Research Organization/Pharmaceutical company
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Organizational and problem-solving skills.
• 5
• 25%-35% domestic travel is required
• Bachelor's Degree in a scientific discipline or health care preferred
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Or equivalent combination of education and experience
• Good therapeutic and protocol knowledge as provided in-company training.
• Effective time and financial management skills.
• Computer skills including proficiency in the use of Microsoft Office Suite and use of a laptop computer and iPhone and iPad (where applicable).
• Strong written and verbal communication skills including good command of the English language.

The anticipated salary range for this position is $90,000 - $130,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. DermTech is a multi-state employer and this range may not reflect positions that work in other states.

Additional Information

An Equal Opportunity Employer/Veterans/Disabled.

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 us at talent@ dermtech.com.

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.