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Job (this posting is closed/inactive)

Seattle Genetics

General Information

(222079)

Job title: Senior Clinical Research Associate
Job location: Bothell, WA 98021 United States
Requisition code: 1207KM-01
Date posted: 01/10/13
Job type: Full-Time
Compensation:

Job Classification


Job Category:Other

Job Description


Job description:
The Senior Clinical Research Associate is responsible for monitoring and or management of the clinical trial monitoring function of Seattle Genetics clinical trials. This position focuses on coordination of all activities required to initiate, maintain and close -out clinical trials. May lead a clinical trial or selected activities.

Responsibilities:
• May act as Protocol Lead on one or more clinical trials. Protocol Lead activities include:
o If any portion of the clinical trial site monitoring function is conducted by a CRO or contract CRAs, responsible to ensure performance meets the terms of the contract.
o Serve as the main point of contact and coordinate day to day activities for all assigned clinical operational and/or clinical trial site monitoring functions.
o Facilitates information flow between all members of the clinical operations/clinical trial site monitoring team, including in-house departments, clinical project team members, external CRO or contracted members, clinical field force, vendors, and personnel as appropriate.
• May coordinate day-to-day activities of clinical trials.
• May participate in the design of clinical trial studies in collaboration with senior management, clinical project manager, medical monitor, biostatistician, and regulatory affairs.
• May create and track detailed project plans for assigned clinical trials.
• Problem-solve specific clinical trial issues.
• Participate in the design and preparation of clinical trial documents such as protocols and case report forms.
• May participate in the identification, evaluation and selection clinical investigators.
• May train, mentor, or manage less experienced CRAs or CTAs.
• May manage external vendors.
• Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.
• Lead development of Informed Consent template(s).
• May develop and lead Quality Control initiatives for a clinical trial.
• Compile data for data review, create tables and graphs under appropriate supervision
• May assist in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections.
• Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.
• Perform the following routine clinical trial site management and monitoring functions;
o Problem-solve specific clinical trial site issues.
o Monitor clinical trials sites for protocol compliance and GCP/ICH adherence.
o Source document review and comparison to CRF data, CRF review/retrieval and data corrections, maintenance of on-site clinical investigator files, review of IRB/EC documentation, review local laboratory documentation, maintenance and reconciliation of investigational drug supplies, review informed consent process for each subject (Informed Consent Form and source documentation), and ensure all Serious Adverse Events (SAEs) have been reported as required and reconcile with clinical database as required.
o Arrange for availability of adequate investigational drug supplies, as well as, review of clinical trial site management including storage, accountability, reconciliation and destruction.
• Conduct clinical trial site monitoring visits and clinical trial site management including:
o Pre-study, initiation, monitoring, and close-out visits, telephone contacts, and follow-up all outstanding clinical trial site issues to resolution and/or documenting attempts to resolve all issues following close-out of clinical trial sites.
o Participate in process development initiative(s).
o Adhere to the clinical trial site monitoring plan for each clinical trial.
o Manage research specimen sample shipments to central lab/s.
• Ensure clinical trial site training records are current and maintained as required
• Coordinate clinical trial site monitoring staff activities including review and ap

Job Requirements


Education, training, experience:
• 5 to 7 years Clinical Monitoring experience in the Pharmaceutical Industry, or equivalent
• Bachelors in scientific discipline or any relevant and qualifying medical training, RN or health care professional - Oncology and Hematology Clinical Research experience preferred
• Past experience working in both a CRO and/or sponsor a plus
• Ability to travel (domestic and internationally)
• Knowledge of FDA, ICH and local regulations/ guidances
• Understand clinical drug development process
• Proficient in development of clinical documents
• Good communication and organizational skills
• Ability to understand complex scientific protocols/concepts
• Excellent organizational skills required
• Excellent Clinical trial site monitoring skills

Seattle Genetics is an equal opportunity employer.
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