Contract research scientist vs clinical research associate

Differences between contract research scientist and clinical research associate duties and responsibilities

Contract research scientist example responsibilities.

• Manage the development of innovative visualization and concept mapping of contest environment analysis challenges and analyst skill sets.
• Test 50 breast expanders and submit results for FDA 5-10k approval.
• Perform solution and standard prep, Agilent HPLC impurities identification, dissolution assay using VanKel (USP App.
• Develop, validate and implement robust methods for pharmacokinetic, immunogenicity (ADA) and immunodepletion ELISAs, and cell based-bioassays.
• Interpret metabolism data and review reports to support strategies forward thinking with a specialization in drug metabolism and metabolic enzymes.

Clinical research associate example responsibilities.

• Manage, schedule and train up to 15 CRAs.
• Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
• Manage site TMF to ensure communication requirements adherence
• Manage CRO and regional monitor to complete close out activities, including device accountability management.
• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.
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