Clinical Trial Specialist

Clinical Operations        ·        South San Francisco, CA       ·       Full time 

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

Would you like to take part in developing new therapies that really make a difference in patients’ lives? Do you desire both autonomy and collaboration in taking on scientific challenges that interest you? Are you interested in joining a talented team where everyone has a voice?

The Clinical Trial Specialist (CTS), works closely with the Clinical Operations team to support clinical trial execution. Key accountabilities include the coordination of activities associated with the start-up and management of a clinical trial in compliance with SOPs, regulations, and ICH/GCP guidelines. The CTS interacts with the program and study managers, Director of Clinical Operations, Regulatory, and other key functions both internally and externally to support activities and project deliverables within the required time frame and budget.

During the first year, your goals will include:

• Complete clinical trial tasks and efficiently for assigned studies
• Assist with oversight of clinical study by tracking CRO and third-party vendors activities
• Manage vendor(s) with supervision
• Coordinate investigator site contract and budget review
• Collaborate with study team to develop clinical trial documents, including informed consent forms, monitoring plans, protocols and amendments, trial logs, site tools, and other documents, as required
• Assist with budget oversight by tracking site payments and vendor invoices in collaboration with finance and study team
• Support study execution, according to good clinical practices (GCP) and standard operating procedures (SOPs). May coordinate activities with Clinical Research Organization (CRO), study vendors, and clinical sites.
• Provide general logistical and administrative support for clinical trials, such as creating agendas and taking minutes at meetings, preparing for investigator meetings, and assisting with purchasing and work orders

We’d love to hear from you if:

• You take pride in being highly organized and have a strong attention to detail
• You thrive in an environment where we work independently and on teams
• Your academic background includes a Bachelor’s Degree, preferably in a health or science field
• You have at least 2+ years experience in clinical operations and study management within a life sciences company or at a CRO. Study Coordinator experience will be considered.
• You have experience with the study start-up process, global Phase I and II clinical trials – particularly Neuroscience, Oncology, orphan diseases and/or Immunology trials, and various clinical trial management systems (desirable)
• Basic knowledge of ICH/GCP and FDA regulations
• Occasional travel may be needed
• You have a point of view but are low ego

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Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a treatment, where you’ll drive growth, this is your role. There is no limit to how far you can go with us.

Among the things you’ll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly-lit offices in the heart of the biotech area, flexible remote work options, and competitive compensation and benefits. But these matters only if you’re excited to build and own something great, and tackle these challenges with us. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief. 

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Please click here to apply.