Quality Recruiting. Established Experts.
Clinical Research Associate/Senior Clinical Research Associate
Reference Number: 2809
Location: NYC Area
Our client is a clinical stage biopharmaceutical company developing novel oncology therapeutics. They have asked us to assist them in their search for a Clinical Research Associate/Senior Clinical Research Associate.
The Clinical Research Associate/Senior Clinical Research Associate supports the project clinical teams by performing tasks related to study management, from startup to completion. This position distributes, collects/tracks study documentation/supplies, and accurately completes project deliverables within project timelines.
Major tasks and responsibilities will include:
- Provides cross functional clerical and administrative support to project team(s).
- Maintains study-specific tracking reports (e.g. patient enrollment, regulatory documents, site visits, AE/SAE, Protocol deviations).
- Prepares and compiles study related materials.
- Obtains, reviews, and processes regulatory and administrative documents from investigator sites.
- Sets up, maintains and reviews regulatory and administrative documents for the Trial Master File (TMF).
- Resolves issues, questions, and requests for additional study supplies.
- Reviews investigator files to ensure all documentation is complete and up-to-date.
- Reviews Electronic Case Report Forms (eCRFs) and other clinical data for completeness and accuracy.
- Reviews Tables and Listings generated from study data.
- Assists project team(s) in updating project reports and plans, and meeting minutes.
- Understands study protocol and is able to process amendments.
- Prepares study related documents such as Informed Consent Form, protocol review and pharmacy manual.
- Tracks and reviews study monitoring reports.
- Reconciles study invoices.
- Facilitates CDA and CTA’s and tracks progress.
- Supports overall trial operation.
- Follows up with CRO / Clinical Sites as needed.
We seek candidates with the following qualifications:
- Bachelor’s degree preferred.
- 2+ years of experience supporting clinical trials in a pharmaceutical or biotech company or another CRO.
- Experience in reviewing and understanding site regulatory documents and clinical trial related documents.
- Medical/scientific writing skills preferred.
- Detail oriented, strong interpersonal and organizational skills and ability to multitask.
- Experience working in team environment.
- Experience in GCP and clinical research knowledge.
- Ability to work independently, prioritize work, and handle simultaneous assignments under tight deadlines.
- Demonstrated ability to develop complex reports, schedules, correspondence, and other administrative documents.
- Experience handling sensitive and confidential business matters and information with discretion.
- Ability to work collaboratively across organizations.
Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2809. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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