Clinical Research Associate

Job Description:Company Information:Breakthrough Careers!A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.Position Summary:Working in the Clinical Operations-Late Stage team, the Clinical Research Associate will participate as a clinical team member in the management and execution of late stage and investigator initiated trials to fulfill program goals, and oversee activities for investigational trials.Duties and Responsibilities:Primary point of contact for investigator site questions.Reviews investigator site contracts.Review site specific ICF templates.Limited on-site monitoring activity including SDV, compliance with protocol and regulations, drug accountability. Ensure documentation of study site interactions (TCRs and trip reports).May be involved with organizing or participating in investigator meetings, study report writing, protocol development, CRF and study manual development. Assist with vendor management.Serves as liaison between the sponsor and the investigator, serves as a resource for investigational site queries, reviews investigator contracts, and participates in project team meetings on a regular basis. Travels to investigational sites to verify that: the rights and well-being of human subjects are protected; the reported trial data are complete, accurate, and verifiable per source documents; and that the trial is conducted in compliance with the currently approved protocol, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs). Other responsibilities may include verifying proper storage conditions, accountability, and disposition of the investigational products and maintenance of up-to-date and accurate investigator study files. Writes and submits written reports of investigational site findings. May be involved in organizing or participating in Investigator's Meetings, study report writing, and the development of Protocols, Case Report Forms and Study Procedures Manuals.Qualifications:Basic qualifications:BS/BA with 2+ years clinical trials experience in industry (CRO, biotech, pharmaceutical) or in a clinical trial setting (hospital).Preferred qualifications:Minimum of 1+ year experience of independent monitoring. Experience with all study visits and ideally all clinical phases.Strong knowledge of FDA/GCP/ICH guidelines.Proficient in MS Office.Detail oriented. Ability to multi-task. Good interpersonal and communication skills.The position includes travel up to 30%.Click here to immediately applyWant to learn more about us? Years of Experience Required: At Least 3 YearsExpected Travel Time: None Searchable Keywords: SAS / gj-moExpected Travel Time: None Company: Millennium Pharmaceuticals, Inc. Contact: Recruiter Email: Apply by Email Address: 02454 Reference Code: 14467.26412.5378BR Company: Millennium Pharmaceuticals, Inc. Status: Full Time, Employee Job Category: Biotech/R&D/Science