Senior Clinical Research Associate
Dendreon Corporation (Nasdaq: DNDN) is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp.
The Clinical Research Associate is responsible for assisting with protocol design, data management plans, and monitoring of all phases of clinical trials. The Senior CRA participates in the negotiation of timelines, milestones, and resource needs with internal and external project team members, and supports the Clinical Trial Manager in training and mentoring less experienced staff members.
Principal Duties and Responsibilities:
- Lead CRA for multiple clinical trials; primary liaison with CTM.
- Independently manages complex data management and clinical site issues.
- Assures completeness of required clinical site regulatory document packages prior to initiation of the clinical site and shipment of IP.
- Primary contact for Contract Research Organizations; responsible for coordination, monitoring and management of CRO services.
- Develops project-specific processes/infrastructure and develops protocol-specific reference materials.
- Responsible for tracking project-related intra- and inter-departmental tasks to assure adherence to timelines.
- Responsible for tracking safety & efficacy data of trial to the extent possible with respect to blind and informing appropriate management.
- Coordinates tracking of study enrollment and study finances.
- Implements and assists with writing departmental SOPs with guidance from Clinical Trial Manager.
- Interfaces with Legal Affairs in negotiating contracts for new clinical sites.
- Assists with selection and management of outside vendors.
- Supervises regional CRAs and co-monitors as needed to assure consistency and quality of monitoring.
- Identifies and qualifies new clinical sites.
Job Specifications and Requirements:
- Requires a Bachelors degree in a scientific discipline, RN or BSN degree or equivalent with 4 years clinical research experience.
- CRA certification (ACRP or equivalent) is strongly preferred for recognition of professional experience and knowledge.
- In-depth knowledge of FDA and GCP regulatory requirements, as well as the ability to apply the regulations to clinical monitoring, and to ability to instruct less experienced staff on these regulations is required.
- Excellent oral and written communication skills.
- Experienced in writing of clinical reports and other clinical documents.
- Able to work effectively on complex clinical trial issues and independently make sound judgments about clinical trial operations.
- Demonstrated ability to act independently concerning all trial procedures and supervises the activities of other lower level personnel.
- Strong team-building and leadership skills; effective negotiator; ability to effectively coordinate tasks across departments and with outside vendors.
Working Conditions and Physical Requirements:
- The job is performed in a normal office environment.
- Physical requirements include ability to operate a personal computer, automated office equipment, and to work at a desk for long periods of time with frequent opportunity to move to other locations within the building.
- Travel is required, estimated to be 30% of the time.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.
We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options. Please visit www.Dendreon.com/dndn/careers to submit your resume.
Reference Job Code: 4770
Dendreon Corporation is an Equal Opportunity Employer