Clinical Trial Associate (12-month TERM)

12-month TERM

 

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

 

The Clinical Trial Associate (CTA) will provide support to the lead Clinical Trial Manager and study management team, assist with the study execution, clinical tracking and document maintenance as applicable to the clinical study vendors and trial sites and in accordance with Denali SOPs, ICH/GCP/regulatory guidelines.

 

Responsibilities

• Perform general clinical administrative functions such as clinical trial tracking and logistical support to the study execution teams (SET), including generation and distribution of SET meeting agendas and minutes

• Tracks and maintains study information and reports on study progress and enrollment

• Tracks and maintains study-related documents, including essential regulatory documents from clinical sites and any other supplementary documentation as appropriate (CVs, FDA 1572s, etc.)

• Independently maintain the study Trial Master File (TMF) in accordance with the relevant SOPs to ensure accuracy, completeness and adherence to the SOPs requirements.  

• Maintains and ensures that all documentation is in a state of audit-readiness

• Assist in the review and development of study-related documents and tools including but not limited to site regulatory packages, study manuals, reference documents and instructions

• Assists with study closure activities such as ensuring final sites payments, final reconciliation activities, filing, and archiving of all study documents. 

• May assist with the tracking of study budgets and vendor invoices to ensure timely approval and payment

• Assist with vendor management and associated logistics, as assigned

• May assist with clinical data review 

• May assist with informed consent development and review

• May assist in creating and implementing departmental procedures 

• Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards

• Contribute to wider organizational goals and/or activities as assigned

 

Requirements

• BS/BA in Life Sciences or related discipline

• 0 to 2 years of related experience and/or combination of experience and education/training

• Preferred knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials

• Highly proficient in software applications such as Word, Excel, and PowerPoint 

• Good written and verbal communication skills and proven ability to multitask

• Efficient time management and organizational skills. 

• Strong interpersonal skills with reputation for collaboration with colleagues

• Attention to detail and accuracy in work

 

Denali is committed to its core company value of unity by creating a diverse and inclusive environment.  We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $95,000 to $114,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

*This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future. 

 

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