To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02660

About our client Our client is a rapidly growing biopharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of various lung disease therapeutics. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees; this is a great opportunity for the right candidate! Position Location Senior/Lead Clinical Research Associate Woburn, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the overall conduct of one or more clinical trials 2) Establish and maintain primary communication with clinical sites and monitors 3) Organize and participate in investigator meetings 4) Conduct on-site clinical monitoring during data deadlines, including document review, ensuring accurate data recording, verifying patient data, etc. 5) Adhere to the protocol of a clinical trial, drug accountability in accordance with GCP, Code of Federal Regulations (CFR) and company SOPs 6) Assist the Clinical Project Manager with communication to investigational clinical sites to obtain study status 7) Facilitate IRB submission, queries and approval process 8) Participate in development of study-related documents, including informed consent form template, monitoring plan, template source documents, study manual(s), regulatory binder, pharmacy binder and other resource materials 9) Participate in site selection and site initiation visits 10) Manage SAEs tracking system 11) Ensure that SAEs are reported in a timely manner and is appropriately followed-up 12) Communicate with and train Medical Team members 13) Manage distribution, collection and tracking of regulatory documentation to ensure site and sponsor compliance, and audit readiness 14) Participate in coordinating preparation of training materials for site initiation, monitor training and mentor new clinical team members 15) Track and report clinical study progress, including screening/enrollment, monitoring reports, data management queries and adverse event documentation 16) Assist in query resolution 17) Identify and gather missing or incomplete data from clinical sites Requirements 1) BS degree in Science/health-related field preferred 2) 3 – 5 years of on-site monitoring experience in a pharmaceutical or biotech setting with a sponsoring company 3) Experience in a clinical healthcare setting preferred 4) Clinical experience as a Respiratory Therapist, Nurse, Pharmacist 5) Pulmonary study experience a plus 6) Working knowledge of GCP, ICH and FDA regulations 7) Good attention to details 8) Positive and self-motivated with an ability to work as a team player 9) Ability to work in a fast-paced, dynamic setting 10) Ability to manage multiple tasks in a collaborative environment 11) Ability to work in a medical setting and interface 12) Strong problem-solving skills 13) Superb knowledge of medical terminologies 14) Excellent interpersonal, organization, written, communication and computer skills 15) Willingness to travel (25% – 30%)