Location: Boston,MA, USA
Job Description: Pay Range: $55hr - $60hr Responsibilities: Independently conduct all types of monitor visits, for-cause, interim and closeout, and/or remote visits as needed, in accordance with the Monitoring Plan. Perform source document verification/review in accordance with the Monitoring Plan. Schedule and conduct visits in accordance with the Monitoring Plan. Complete monitoring visit reports and enter them into an electronic database, confirmation letters, and follow up letters on time, in accordance with Monitoring Plan and/or SOPs and Guidelines. Observe participant clinic visits and provide feedback to study coordinators on adherence to trial protocol and operations manual, as appropriate. Perform Informed Consent Form (ICF) reconciliation to ensure all trial subjects have fully completed and signed the correct version of the form. Collect and submit other regulatory documents as necessary. Effectively perform protocol and other on-site study training to investigator and site study staff. Perform drug accountability. Review ISF and resolve noted deficiencies in a timely manner. Identify and resolve site level Corrective and Preventative Actions (CAPAs) in a timely manner, in coordination with Clinical Trial Protocol Coordinators. Co-monitor as needed or facilitate co-monitoring visits. ttend and participate in investigator and coordinator meetings as requested. ssist with site preparation for audits (Regulatory Agency, Sponsor, etc.). Maintains department service standards as outlined in the MGH Code of Conduct Qualifications: Bachelor's Degree required, in science/health related field preferred. Minimum of 5 years in clinical trial related experience for multi-center national clinical trials. Previous clinical monitoring experience required. Certified Clinical Research Professional (CCRP) or equivalent and/or Certified Clinical Research Associate (CCRA) preferred. Experience with pain studies and medical terminology preferred. Knowledgeable of Electronic Data Capture Systems, including ePRO, eCOA, eICF and IWRS required. Competencies Required: bility to accept a responsibility for decision-making as it relates to the conduct of field monitoring for domestic clinical trials.2. Excellent judgment and ability to interpret information and protocol requirements, and initiate appropriate actions given competing priorities. Outstanding interpersonal and leadership skills to effectively interact with Sr. Management, Principal Investigators, Trial Staff. Outstanding written and oral communication skills 5. Outstanding organizational abilities to formulate and complete rigorous timetables. bility to travel nationally on short notice.