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Job #02661

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 Clinical Research Associate Woburn, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor one or more clinical trials 2) Establish and maintain communication with clinical sites 3) Conduct site pre-investigational visits 4) Organize and participate in investigator meetings 5) Conduct on-site clinical monitoring that includes document reviewing, ensuring accurate data recording, verifying patient data, etc. 6) Adhere to the protocol of a clinical trial, drug accountability in accordance with GCP, the Code of Federal Regulations (CFR) and company SOPs 7) Maintain regular telephonic contact with sites 8) Prepare trip reports and recommend corrective action where appropriate 9) Conduct closeout visits, including reviewing record retention requirements along with securing and reviewing investigator’s final report 10) Assist the Clinical Project Manager in communicating with the investigational clinical sites to obtain study status 11) Maintain written correspondence with site 12) Assist in reviewing CRFs design for research data collection of subject safety and efficacy parameters as required by the study protocol, Federal regulations and GCP 13) Act as sponsor liaison to resolve any site related issues quickly and effectively in conjunction with the Clinical Project Manager 14) Participate in developing study-related documents, including informed consent form template, monitoring plan, template source documents, study manual, regulatory binder, pharmacy binder and other resource materials 15) Facilitate IRB submission, queries and approval process 16) Participate in reviewing protocol and amendments, investigator brochure and CRFs 17) Assist in clinical site contract and budget development and negotiation 18) Participate in managing distribution 19) Collect and track regulatory documentation to ensure site and sponsor compliance and audit readiness 20) Train materials for site initiation, contract monitor training and mentoring of new Clinical Team members 21) Assist in query resolution 22) Identify and gather missing or incomplete data from clinical sites 23) Communicate and train medical team members Requirements 1) BS degree in Science/health-related field preferred 2) 2 – 3 years of clinical research experience in a pharmaceutical, biotech or CRO setting 3) Experience in a clinical healthcare setting preferred 4) Clinical experience as 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 team player 9) Ability to work in a fast-paced and dynamic setting 10) Ability to manage multiple tasks in a collaborative environment 11) Strong problem-solving skills 12) Superb knowledge of medical terminology 13) Excellent interpersonal, organizational, written, communication and computer skills