Primary Responsibilities:    The Clinical Trials Associate will work within the Clinical Operations Department and reports to the Associate Director. The CTA assists in performing and coordinating all aspects of clinical trials in accordance with GCP, ICH, U.S. IND Regulations, AMAG SOP’s. Primary responsibilities include performing the daily operations associated with clinical study protocols.
Tasks Performed:    •    Participate in the direction, planning, execution and interpretation of the clinical research project through site management and communications both in-house and in the field. Assure successful conduct of assigned clinical study sites consistent with applicable regulations, guidelines and policies. Assist in ensuring adequate monitoring of study (for example, helping to assure that CRO accomplishes all tasks, that resolution of all issues noted by monitors are documented and appropriate and that corrective and/or preventative action is taken to avoid recurrence as necessary.) Create and maintain tools to report and measure study progress. Assist with contractor management and QA especially of monitoring and study management, but also of other area contractors (SMO’s, IVRS, etc.).
Essential Functions:   
Minimum Physical Requirements:   
Desired Education:   
Desired Degree:     Bachelor of Science degree with a scientific basis is required
Desired Major:   
Desired Job Experience:    2-4 years experience in clinical research with work history as a CRA.
Certifications Required:   
Other Qualifications:    The CTA must have the ability to function in an atmosphere of changing priorities and tight deadlines. This position Requires a strong knowledge of clinical research study design, GCP and regulatory compliance guidelines for clinical trials combined with strong prioritization, organizational and problem solving skills. Exhibit attention to detail. Extremely accurate and have strong interpersonal communication skills. Excellent computer skills including Word, Excel and Power Point. Since site visits will be required, the CTA II must be able to travel 30%.