Clinical Research Associate III (medical Affairs)

About Cerus: Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world. Summary & Scope of Position: Assist with the design and implementation of clinical research projects. Primary Responsibilities:

• Assists with clinical trial operations.
• Evaluates, monitors, and facilitates flow of clinical data to ensure accuracy.
• Manages activities of investigational sites to ensure compliance with protocol and overall clinical objectives.
• Travels to investigational sites to conduct pre-study, initiation, interim, and closeout site visits.
• Maintains a high level of professional expertise through familiarity with GCPs (domestic and international).
• In collaboration with others, writes protocols, informed consent forms, study manuals, and final reports.
• Oversees and participates in development of case report forms, study start-up documents and study tracking tools.
• Collaborates with CROs and vendors to accomplish clinical objectives.
• Assists with the negotiation of investigational site budgets, site payments and assists with CRO management and payment.
• Participates in tracking of subject enrollment and collection of safety information for interim analyses.
• Participates in the writing and regular review of SOPs for clinical operations.
• Maintains central study files in a state of audit-readiness.
• Generates and distributes internal and external project team meeting minutes.
• Acts as company’s representative.
• May provide guidance to other personnel.
• Perform other related duties as required.

Qualifications/Requirements/Skills:

• BS or equivalent with a minimum 5 years of experience in clinical research.
• Knowledge of FDA regulatory requirements.
• Ability to work independently.
• Ability to work in an ambiguous, face paced environment.
• Excellent communication skills (interpersonal, written, verbal, listening).
• Excellent time management skills (timelines, schedules, task prioritization).
• Broad knowledge of medical terminology and industry.
• Attention to detail and accuracy.
• Willing and able to travel (international and/or domestic) a minimum of 25% of time.
• Experience with FDA submissions and inspections.

We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees’ lives both on and off the job. Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement Compensation: The base salary range for this position if candidate is based in the the SF bay area $113,000-$138,000 annually. Compensation may vary outside of this range depending on various factors, including a candidate’s qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.