Clinical Research Specialist

at  Katalyst Healthcares Life Sciences

Responsibilities:

• Site Management experience (site or sponsor).
• Knowledge of/experience with CTMS/EDC/TMF.
• Experience with Good Clinical Practice (GCP).
• Oversees, designs, plans, and develops clinical evaluation research studies.
• Prepares and authors protocols and patient record forms.
• Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
• May be responsible for clinical supply operations, site and vendor selection.

Requirements:

• Requires a University Degree and minimum of 2 years of relevant experience.

• Site Management experience (site or sponsor).
• Knowledge of/experience with CTMS/EDC/TMF.
• Experience with Good Clinical Practice (GCP).
• Oversees, designs, plans, and develops clinical evaluation research studies.
• Prepares and authors protocols and patient record forms.
• Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
• May be responsible for clinical supply operations, site and vendor selection