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Clinical Study Associate

Company Name:
Executive Personnel Services
Clinical Study Associate
This is a year long temporary position 09/14/2015 to 09/09/2016
Collegeville, PA. 19426
8hrs per day
40hrs per week
$30.26 per hour

This position is structured to manage clinical trial activities according operating standards and good clinical practice and to ensure that studies receive the support needed to meet or exceed customer expectations on time and within budget.
This role supports US and Global R&D and USP Clinical Trials, Phases I-IV. Individual will interact with internal matrix partners and external partners (e.g., Investigators, Sites and vendors).
Responsible for the accuracy and integrity of data within the compay study systems through independent and proactive gathering, entry and interpretation of information from systems to support studies.
Active participant of or lead clinical study teams as appropriate.Develop study specific processes and procedures for operationalizing studies and oversee standardization and dissemination of best practices.
Oversee study related logistics, resolve complex requests, recognize underlying issues, and communicate issues and proposed solutions as appropriate.
o Relevant documentation in place and tracked to meet required regulatory guidelines for study conduct
o Application of specialized knowledge of the company processes and procedures, SOPs and ICH guidelines in conduct of clinical studies to meet established timelines, milestones and study objectives
o Quality of data in GSK study systems to ensure accurate and timely planning, monitoring, execution and reporting of clinical studies
o Best practices are shared and implemented internally and externally and serves as a change agent (with oversight where applicable)
o Coordinate workflow, tasks, and staff to accomplish study or project deliverables
o Review and track (with oversight where applicable) study invoices and accruals, including resolution of investigator grant payments, invoice accuracy, comparison to contract and outstanding payments.
o Project and allocate external study expenditures relevant to clinical support activities (e.g. HCP meetings, vendors)
o Serves as point of contact for study support questions for internal and external customers for assigned study(s) (e.g. feasibility and site recruitment process, submission for central ethics approval, tracking of regulatory, financial and legal documents, study systems etc.).
o May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.
o Proactively interpret, draw valid conclusions, and summarize information from systems to support studies, including the development of complex/innovative information management solutions and systems.
o Able to suggest and/or develop methods for reporting from the company and vendor systems for centralized planning and tracking.
o Demonstrates strong communication skills that strategically influence internal and external partners to ensure that they have current and accurate information regarding study activities.
o Partners include Investigators, Site Personnel, the Global study team, Vendors, the company Senior Management and Internal the company Matrix Partners. CSA should seek to understand each partner, formulate appropriate responses and communicate effectively.
Skills Required:
oRequires undergraduate degree or equivalent in a health or science related discipline. oDemonstrates solid scientific expertise
oPossesses working knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research
oDemonstrates some drug development experience within the pharmaceutical industry
o3-5 Years + of experience
o Proficiency in multiple software applications
o Comprehensive knowledge of the clinical development process and FDA/ICH/GCP regulations
o Able to perform study-related tasks with minimal or no oversight
o Experience working on multiple clinical studies, including complex projects assignments in a matrix environment.
o Experience training or mentoring staff in Clinical Development processes and procedures and FDA/ICH/GCP guidelines.
o Experience overseeing or leading teams for complex initiatives or multiple study projects.
o Experience independently managing projects and assignments, including assuming full accountability for delivering results.

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