Regional CRA Job in Boston, Massachusetts US

Regional CRA

Regional CRA Job Description: Our pharma client is rapidly growing and is need for an Regional CRA monitor based in the NorthEast area. Clinical Research Consultant (Regionally Based) The Clinical Research Consultant is responsible for tasks that relate to the monitoring and management of clinical trials. Regionally based consultants work out of their home office providing monitoring of Phase 1-4 clinical trials, assuring adherence to Good Clinical Practice. This position may consistently involve up to 65% travel. Regionally based Clinical Research Consultants may be involved in some or all of the tasks listed below: - Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out. - Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion. - Managing, preparing, sending, tracking, and returning investigational supplies at individual sites. - Monitoring and documenting investigational product dispensing, inventory, and reconciliation. - Monitoring and documenting laboratory sample storage and shipment. - Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities. - Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues. - Reviewing data queries and listings, and working with the study centers to resolve data discrepancies. - Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues. - Maintaining complete and accurate study files, and reviewing files to ensure all appropriate documentation is present. - Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials. - Other tasks or responsibilities as assigned. Physical Requirements - Ability to work efficiently on the computer, including document retrieval, review, and tracking, that may include but not be limited to: - Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules. Environment - The Clinical Research Consultant (Regionally Based) works from their home office, and travels to study site and meeting locations. Hours and time recording - The Clinical Research Consultant is expected to manage her/his time in a professional manner and to generally work a 40-hour week unless another schedule has been agreed on with Management and the client in writing. - Time worked is expected to be flexible, based on travel and site-appointment requirements. Although the assignment is expected to be completed within the agreed-upon work week, weekly or daily time required for the position will vary, depending on business needs and expectations. Qualifications " Minimum Required - Nursing registration or licensure and/or 4-year degree, preferably in a scientific or health care discipline, or equivalent combination of education, clinical research certification, and/or experience. - At least 3 years of prior experience as a Clinical Research Associate, including monitoring experience. More experience may be required for specific assignments. - Must have availability of a car in good condition, a valid driver's license, a good driving record, and car insurance. - Successful completion of the hiring process, including interviews and reference checks. Full Benefits and paid time off are provided in this position. Interested candidates should contact Laura Walton at 201-793-1006. Required Skills for Regional CRA Job: CLINICAL MONITORING OPERATION ROOM/MEDICAL DEVICE About Aerotek Scientific: Join Aerotek Scientific 74 LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Additional Info Minimum Age 18+ years old Job Industries Healthcare