Clinical Research Associate Iii

7 months ago

Concord, Canada Cerus Corporation Full time

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.

This is a hybrid opportunity.

Summary & Scope of Position:
Primary Responsibilities:

- Assists with implementation of registration trials at study sites.
- Monitor and evaluate trial data to ensure quality and accuracy consistent with the protocol and ICH/GCP Guidelines and Code of Federal Regulations.
- Coordinates activities of investigational sites to ensure compliance with protocol and overall clinical objectives.
- Oversee trial supplies (device, reagents, lab supplies) at sites and ensure trial supplies are available at sites as needed.
- Assists Early Clinical Development and Regulatory Affairs with clinical trial submissions and updates.
- Oversee site IRB submissions, providing assistance as needed, and tracking approvals/approval expiration.
- Collaborates with other cross-functional teams for the start-up, conduct, and closeout of registration studies.
- Travels to trial sites to assist with and/or lead pre-study, study initiation, interim monitoring, and closeout site visits, and completes trip reports.
- Maintains a high level of professional expertise through familiarity with GCPs, GLP and GMP.
- In collaboration with others, develops protocols, informed consent forms, study manuals, case report forms, study worksheets, training materials, reports, monitoring trip reports and other study related documents.
- Assists with and tracks the negotiation of investigational site, CRO and vendor budgets, and site, CRO and vendor.
- Participates in the writing and regular review of procedures for Early Clinical Development.
- Maintains central study files in a state of audit-readiness.
- 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 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.
- Science background and experience with complex in vitro diagnostic devices preferred.
- Laboratory experience or knowledge of laboratory operations preferred.
- Attention to detail and accuracy.
- Willing and able to travel a minimum of 30% 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

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.

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