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Senior CRA II
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Organization: Clinical and Systems Resource Group
View Company Profile of Clinical and Systems Resource Group :: View more jobs from Clinical and Systems Resource Group
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Job Description:
This position focuses on coordination of all clinical operations / monitoring activities required to initiate, monitor and complete clinical programs at the clinical trial site level; oversee, may manage direct reports and act as mentor for less senior members of the Clinical Trial Team. Provide the clinical operation input to the clinical project team managed by the clinical project manager.
DETAILED DUTIES & RESPONSIBILITIES:
?Coordinate and manage vendor processes for the clinical operations / monitoring function of clinical trials including clinical site management, clinical site monitoring, data management and central laboratories activities.
?Participate in the evaluation, training and refining of departmental Standard Operating Procedures (SOPs) and guidelines, and the development of standard reports, templates and forms.
?Train, mentor, and may manage Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) in clinical trial management, processes and all applicable regulations.
?Act as Protocol Lead (PL) which may include activities as follows:
oIf any portion of the clinical operation/monitoring function is conducted by a CRO or contract CRAs, responsible to ensure performance meets the terms of the contract.
oServe as the main point of contact and coordinate day-to-day activities for all internal and external clinical operational/ clinical trial site monitoring functions
oFacilitate information flow between all members of the clinical operations/monitoring team, including in-house departments, clinical project team members, external CRO or contracted members, clinical field force, vendors, and personnel as appropriate.
oManage clinical trial information and document flow to and from clinical trial sites and/or external vendors.
oManage clinical trial site monitoring team metrics (i.e. CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc) to ensure performance maximizes efficiency, quality, CFR, ICH/GCP adherence, and meet clinical trial and corporate goals (i.e. CRFs expected / outstanding, SDV).
?Oversee investigational drug supply chain and accountability system, including projection of needs, requisition process and accountability activities.
?Oversee the management of research specimen/samples.
?Responsible to provide operational / clinical trial site monitoring input to the key study documents including the protocol, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report as assigned.
?Responsible to create and maintain clinical trial start up documents.
?Provide support to other CRAs in the initiating, monitoring and coordinating day-to-day operations of investigational clinical trial sites as needed.
?Problem-solve clinical trial and related personnel resource issues.
?Manage internal (dotted line or functional) and external CRAs, and other external vendors as assigned.
?Develop and lead quality control strategies for the clinical trial monitoring function.
?Oversee the clinical trial investigators/sites selection process.
?May assist in the preparation and follow-up of in-house and on-site sponsored quality audits, as well as, regulatory authority inspections.
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Skills Required:
?BA/BS or equivalent in a scientific discipline or any relevant and qualifying medical training with a minimum of 8 years of relevant clinical trial management experience.
?Experience should include Phase I-III trials, CRO management and project and contract management.
?Proficiency in ICH/GCP and CFR issues including experience working with the European Clinical Trial Directive is essential .
?Must be willing to travel.
?An advanced degree, oncology/hematology clinical trial experience, NDA filing experience, international clinical development experience is preferred.
?Excellent leadership, communication, and organizational skills, ability to proactively handle multiple tasks and solve problems simultaneously, and intense drive are necessary to manage the diverse group of functional activities involved in clinical project management.
?Act as an advisor to direct reports to meet schedule and or resolve technical problems. Interface with peers, customers or functional peer group managers as well as senior management.
?Requires effective organizational and communication skills.
?Expected to participate in development of processes and best practices and to take ownership of some aspects of departmental development.
?Works on problems of diverse scope (manage larger, complex clinical trials with multiple vendors) where analysis of situations or data requires an evaluation of intangible variables.
?Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
?Acts independently to determine methods and procedures on new assignments.
?May supervise the work of others.
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| Job Category: |
Biotechnology |
| Job Status: |
Full Time |
| Location:
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Seattle, United States |
| Start Date:
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ASAP |
| Salary:
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85,000 - 105,000 |
| Contact:
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Andrew Mammano |
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Email: |
Andrew@srgr.com |
| Reference:
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Senior CRA WA |
| Date Posted:
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8/28/2008 7:10:08 PM |
| Duration:
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