CAREERS
Equillium is a biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need.
At Equillium, everything we do centers around what’s best for patients — they are our reason for being, our driving force for excellence. We feel privileged to work in an industry where we have the opportunity to truly make a difference in the lives of others.
We embrace a culture that is defined by integrity, accountability and open communication. We push each other to approach challenges with creativity and break from the expected — because only then does innovation happen.
Balance is also core to our identity, both in the therapies we create and the way we approach our work. This means we celebrate successes, support each other and always keep a positive attitude. We owe it to each other, to ourselves and to the patients we ultimately serve.
Equillium is seeking individuals who want to make a difference in patients’ lives! Our current job opportunities are listed below.
Please submit resumes and cover letters to careers@equilliumbio.com.
Sr. Clinical Research Associate
Date: 16 January 2019
Title: Sr. Clinical Research Associate
Reports to: Sr. Director, Clinical Operations Dept: Development
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Overview of Position:
Under minimal supervision in Clinical Operations, works with the team to coordinate the activities associated with the evaluation, initiation and management of clinical trials and study sites. May manage clinical studies including site and/or vendor oversight.
Essential Duties & Responsibilities:
- Coordinates the activities associated with site start-up and overall study management, including review of site documents in anticipation of site activation and site oversight through close-out
- Provides review and input on study-specific plans
- Review of clinical protocols and amendments
- Performs operational feasibility assessments for new clinical protocols
- Identifies and recruits clinical investigators
- Review and management of regulatory documents
- Coordinates the review and content of study materials such as eCRFs, study guides and subject instructions
- Assists with the preparation, conduct and presentations for CRA Training at Investigator Meetings
- May assist with coordination and management of study budgets
- Manages the overall Investigational product accountability and reconciliation process
- Assists with the review and oversight of data for quality (e.g. ensures that CRF data queries are resolved)
- Coordinates CRO tracking, and training, including lab samples for central laboratories
- Reviews outsourcing specifications for RFPs
- Builds CRO relationships and provides oversight on vendor performance
- Assists with program oversight, identifies deficiencies and risks, and assists with improvement and mitigation plans
- Ensures compliance with Equillium policies and procedures
- Assists in the preparation of data and documents for inclusion in items such as: Clinical Study Reports, Annual IND safety reports and clinical summaries, as needed
- Review of monitoring reports. Identification and escalation of issues and assists with corrective action plans.
- Intermittent monitoring of clinical sites for adherence to protocol and GCP
- May complete PSSV or other site visits in assistance of CRO and to promote timeline
- Other duties as assigned
Job Requirements:
Education: BA/BS in Biological Sciences or related field, or BSN/RN
Experience:
- 5 years related experience in life sciences or medically related field, including 4 years of experience in industry within Clinical Development (i.e. CRA)
- Experience with development of prospective site-selection criteria
- Protocol input experience
- Familiar with advanced concepts of clinical research
- Ability to deal with time demands, incomplete information or unexpected events
- Experience with interactions with outside vendors (i.e. sites, CROs, contract labs)
- Experience with reviewing adequacy of site-proposed documents for compliance with relevant regulations
Skills and Attributes:
- Attention to detail
- Excellent time management and organizational skills
- Proven ability to manage multiple tasks and associated deadlines
- Exceptional and timely communication and interpersonal skills
- Strong computer literacy, including: Microsoft Excel, Word, Outlook and PowerPoint
- Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
- Travel required 20-50%
Equillium’s recruitment and employment process is managed by Human Resources and all candidates must be submitted through Human Resources. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or present candidates, but instead to contact Human Resources.
Human Resources will review and keep all resumes submitted on file.
Equillium is proud to be an Equal Opportunity Employer.
As part of the biotech industry, Equillium understands and recognizes the importance of providing quality health and financial benefits to employees that are competitive and will support healthy living.
HEALTH BENEFITS
• Medical Insurance Plans – including HMO, PPO and HSA options
• Dental Insurance
• Vision Insurance
LIFE BENEFITS
• Life Insurance and AD&D
• Supplemental Employee and Dependent Life Insurance
• Annual Holidays
• Unlimited Vacation Time
• Annual Sick Time
• Employee Assistance Program
• Travel Assistance Program
FINANCIAL BENEFITS
• 401(k) Plan
• Annual Bonus
• Stock Options