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Job Details

site start up specialist clinical

Company name
Apex Systems Inc

Location
Costa Mesa, CA

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Profile

Global Pharmaceutical Company is seeking a Site Start-up Specialist to join their expanding team! (Clinical Research Coordinators are highly encouraged to apply.)

Responsibilities:

- Execute study start-up for assigned protocols within timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines.

- Oversee Site Start-Up projects as liaison for IRB, IRB submission, and consent form review. Reporting metrics to senior management

- Monitor project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meeting.

- Review and report on deliverables of vendors.

- Maintain the tracking of project metrics in Site Start-Up tracker and provide status updates. Work with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning).

- Manage information sharing (i.e. Site Start-Up tracker, Site Identification Tracking Tools).

- Develop Standard Operating Procedures and Working Documents to document and communicate units processes and procedures.

- Implements process improvement for Site Start-Up initiatives.

- Provide agendas, meeting minutes and manages follow up items for all Site Start-Up meetings that are assigned.

- Follow standard processes for the collection and processing of study site start-up documents and site start-up information.

- Proactively inform manager of down-turns in leading site start-up indicators

- Provide oversight and direction to vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables and providing direction to vendor on task requirements and prioritization.

- Schedule and lead site start-up meetings with clinical team and vendors to review any issues, items for escalation, regulatory document issues, and IRB status.

Requirements:

- BS in scientific discipline

- 2 years of experience in clinical research, study start-up experience desired.

- Strong computer skills

Job ID: ******

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Apex Life Sciences

On Assignments U.S. life sciences businesses, Lab Support and Valesta Clinical Research Solutions, have been re-branded as Apex Life Sciences. The U.S. divisions of Lab Support and Valesta are leaders in the scientific, engineering, and clinical research staffing and services industry. The new name was chosen to leverage the national brand of On Assignments Apex Systems, a leader in the technology staffing and services industry. For over 30 years, Lab Support and Valesta have provided top talent for contract, contract-to-hire, and direct hire positions in the life sciences industries. With hundreds of thousands of successful matches over three decades, the divisions have built reputations as the best in the business. Contact Info

- Costa Mesa, CA

Job Type

Permanent

Job Reference

J3Q0MQ77DP4KSG1

Job ID

19615269

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Company info

Apex Systems Inc
Website : https://www.apexlifesciences.com/

Company Profile
Apex Life Sciences is a division of the 3rd largest clinical/scientific staffing and services firm in the U.S. We match top scientific, engineering, and clinical research professionals at all career levels for contract, contract-to-hire, and direct hire opportunities.

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