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| Job #02763 |
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| 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 (Home-Based) |
California, Illinois, Massachusetts, North Carolina, Pennsylvania, New Jersey, Delaware |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Monitor pre-study, initiation, routine and closeout visits at investigator sites for GCP compliance as per company SOPs and client guidelines 2) Generate study specific documentation, including monitoring trip reports, telephone contact reports, site correspondence and expense reports 3) Recruit investigators for participating in clinical trials 4) Conduct project feasibility assessments 5) Negotiate study budgets with investigators 6) Obtain, review for appropriateness and process regulatory as well as administrative documents from investigator sites 7) Review draft protocols for completeness and feasibility 8) Develop CRFs for clinical trials
9) Participate in Investigator meetings (e.g. study-specific guidelines and
procedures, CRFs and monitoring conventions) 10) Prepare and process Serious Adverse Event (SAE) reports 11) Compile project management reports for clients, project personnel and the management 12) Resolve queries of CRF data with study-site personnel 13) Review tables and listings generated from study data |
| Requirements |
1) Bachelor’s degree or RN 2) Minimum 3 years of CRA experience in monitoring clinical trials (qualification to closeout) 3) 3+ years of experience in field monitoring and site management 4) Experience (recent – last 2 years) in oncology (as the main focus) 5) Proven job stability (consultants not needed) 6) Excellent organizational skills 7) Ability to manage time and work independently
8) Superb communication skills (written and verbal) 9) Willingness to travel – up to
60% |

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