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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment
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 Job #02543 Email this job to a friend
About our client
Our client is a global, publicly traded drug development services company headquartered in New Jersey. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up to date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work!
Position Location
Clinical Research Associate Illinois, San Diego, California, Massachusetts, North Carolina
Salary Reports to
Highly competitive package, commensurate with experience Management
Responsibilities
1) Monitor GCP compliance as per company SOPs and client guidelines at investigator sites (pre-study, initiation, routine and close-out visits)
2) Make and monitor study specific documentation including trip reports, telephone contact reports, site correspondence and expense reports
3) Recruit investigators for participation in clinical trial
4) Conduct project feasibility assessment
5) Negotiate study budget with investigators
6) Obtain/review for appropriateness and process regulatory and administrative documents from investigator sites
7) Review draft-protocols for completeness and feasibility
8) Develop CRFs for clinical trial
9) Prepare and process Serious Adverse Event (SAE) reports
10) Attend investigator meetings (e.g. study specific guidelines and procedures, case report forms and monitoring conventions)
11) Prepare Project Management Reports (PMR) for clients, project personnel and management
12) Review tables and listings generated from study data
13) Resolve queries of CRF data with study site personnel
Requirements
1) Bachelor’s degree or RN
2) Experience in oncology
3) 1.5+ years of field monitoring and site management experience
4) Minimum 6 months of experience in field monitoring for a pharmaceutical/biotech company or CRO
5) Excellent organizational skills
6) Ability to manage time and work independently
7) Excellent communication skills (written and verbal)
8) Willingness to travel – up to 50%
9) Willingness to relocate

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