Clinical Research Associate II

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE^® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs.

Your Role:

Clinical Research Associate II/Senior Clinical Research Associate role is an in-office position. The individual in this role will be primarily responsible for ensuring the timely, high-quality conduct of clinical trials according to protocols, applicable guidelines and regulations.

Your Work:

• Efficient Trial Execution: A Senior CRA's expertise in clinical research and trial management will contribute to the efficient execution of clinical trials. 
• Serves as a liaison with internal and external partners to ensure effective collaboration efforts. Oversees planning of meetings, site visits, and drafting necessary documents.
• Compliance with Regulations: The Senior CRA will play a crucial role in ensuring the organization's compliance with regulatory requirements and GCP principles.
• Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations and ICH/GCP Guidelines.
• Conducts remote and in-person site assessment, initiation, routine, and close-out monitoring visits. Completes accurate monitoring visit reports.
• Provides site guidance on any protocol related issues.
• Coordinates necessary activities required to set-up, monitor, and close-out clinical trials sites.
• Assists in the preparation of routine protocols, informed consents, SOPs, and other appropriate documentation.
• Develops training materials and conducts training for study implementation based on company policies and SOPs. Develops, reviews, and maintains key study documents to ensure adequate resource and reference documentation.
• Other Duties as assigned.

Scope:

• The Senior CRA monitors clinical trial activities to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols. Reviews regulatory documents as required and prepares site visit reports.
• Effective Communication and Stakeholder Management: The CRA II will serve as a central point of contact for investigators, study coordinators, and other stakeholders involved in clinical trials. 
• Works independently and in a team environment.
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
• Contributes to study development and start-up process including reviewing protocols, design and review Case Report Forms (CRFs), preparing Informed Consent Forms (ICF's), developing study documents, organizing investigator meetings and working with management on a monitoring strategy.
• Participates in clinical training programs and maintain awareness of developments in the field of clinical research as needed.
• Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.
• Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of trial systems and procedures as appropriate.
• Ability to manage required travel to sites of up to 50% on a regular basis.

 Education Requirements:

• Bachelor's Degree in scientific discipline or healthcare preferred, required.

Job Requirements:

• Bachelor's Degree in scientific discipline or healthcare preferred, required.
• Minimum of 5 years of clinical trial and multi - site management experience.
• Good therapeutic and protocol knowledge as provided in company training.
• Thorough knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
• Thorough understanding of the drug development process.
• Intermediate to advanced clinical monitoring experience.
• Have a full understanding of Serious Adverse Event (SAE) reporting and follow-up.
• Strong computer skill, including but not limited to the knowledge of Electronic Data Capture Systems (EDC), Clinical Trial Management (CTMS), Electronic Document Management Systems (EDMS) and Office products suchs as Excel, Word, Powerpoint.
• Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.

Working Conditions and Physical Requirements:

• Typical in-office or remote based environment.
• Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
• Technology: Personal Computer, Microsoft Office (i.e., Word, Excel, PowerPoint, etc.)
• Travel: 40-50%