Senior Clinical Research Associate - Seattle Genetics

Position Description

If you are looking for a stimulating environment where discovery and development of therapies to treat cancer patients is the central goal, we are interested in hearing from you! We are looking for a highly motivated individual to join our team as a Senior Clinical Research Associate.



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. Will provide the clinical operation input to the clinical project team managed by the clinical project manager.



MAJOR 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:

o If 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.

o Serve as the main point of contact and coordinate day-to-day activities for all internal and external clinical operational/ clinical trial site monitoring functions

o Facilitate 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.

o Manage clinical trial information and document flow to and from clinical trial sites and/or external vendors.

o Manage 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, 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 research specimen collection, accountability, monitoring, reconciliation, and shipment as needed.

· 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 (participate in the Clinical Protocol Committee as appropriate).

· Responsible to create and maintain clinical trial start up documents including the clinical trial site monitoring plan, CRF completion guidelines. Develop or provide clinical operations / clinical trial monitoring function input for other clinical trial start up activities, including; investigational drug supply plan, research specimen plan, safety plan, communication plan, and other plans and processes as appropriate.

· Provide support to other CRAs and assist 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 initiative for the clinical trial monitoring function.

· Identify, evaluate and select clinical trial investigators/sites.

· May infrequently monitor clinical trial sites for protocol compliance and ICH/GCP adherence.

· 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



REQUIREMENTS:



· Bachelors in scientific discipline or any relevant and qualifying medical training, RN or health care professional, with at least 7 years of pharmaceutical clinical development experience or equivalent. Experience should include Phase I-III trials, CRO management and project and contract management.

· Proficiency in GCP and regulatory issues including experience working with the European Clinical Trial Directive is essential.

· Must be willing to travel up to 20%.

· 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.

· Acts as an advisor to subordinates to meet schedule and or resolve technical problems. Frequently interacts with subordinate supervisors, customers or functional peer group managers and will interact with 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.

How to Apply