Clinical Trial Specialist (CTS)

Work Location

Corporate Headquarters (South San Francisco, CA) Onsite

Position Summary

The Clinical Trial Specialist (CTS) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Global Clinical Operations team.

Responsibilities will range from clinical study coordination to data entry projects and general office work. This position will report to the Sr.

Director of Clinical Operations

Responsibilities

• Help provide accurate and up-to-date study status information to the organization.
• Implement accurate tracking systems, forms, and other relevant documents to support clinical studies.
• Assist the clinical operations team with vendor management, including tracking all study invoices and payments.
• Assist in the preparation of spreadsheets, presentations, etc. utilizing Microsoft Office Suite.
• Assist in the periodic review and QC of eTMFs to support inspection readiness and archiving of completed studies.
• Maintain electronic files of clinical trial documents for ongoing projects.
• Coordinate logistics for clinical operations team meetings, kick-off meetings, etc. Prepare draft minutes from the various meetings for review and finalization.
• Assist in the tracking of clinical lab samples for multiple clinical trials, including tracking shipments of samples from lab vendors and helping maintain documentation of reconciliation practices and follow up any outstanding items.

Requirements

• Science or nursing degree, BA, BS, RN, or higher or equivalent combination of education and experience in Biotech or Pharmaceutical industry sectors.
• 0 -2 years of experience as a Clinical Trial Assistant or Clinical Study Coordinator.
• Knowledge of ICH GCPs is a plus.
• Proficient with MS Word, Excel, and PowerPoint.
• Strong interpersonal, communication (written and verbal)
• Excellent organizational skills.
• Ability to work as part of a multi-functional study team.
• Based in the San Francisco Bay Area

What Annexon offers

• Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve.
• We continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce;
• ensure that Black, LatinX and other underrepresented candidates have long-term sustainable opportunities to work with Annexon;

and hold our vendors to the same standards under which we operate. To learn more about Annexon’s diversity commitment, culture and values, please visit https : / / annexonbio.com / careers /

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.

Compensation

The anticipated salary range for the Clinical Trial Specialist position is $60,000 to $74,700 per year. The starting salary for this position will be determined based on the candidate’s education, experience, transferable skills, licenses / certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation.

The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.

Company Summary

Annexon Biosciences (Nasdaq : ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye.

Annexon’s novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases.

With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible.

To learn more visit annexonbio.com.

EEO Employer Annexon highly values Diversity, Equity, Inclusion and Belonging

Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status.

We are proud to promote a work environment where everyone, from any background, can do their best work.

Staffing Agencies

Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with Annexon Biosciences.

Please do not send agency CVs / resumes through Annexon’s website or Annexon Employees. Inquiries must be sent to talentacquisition@annexonbio.

com with the Subject Heading : Staffing Agency Request.