Clinical Research Associate
Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Kansas City, KS, Seattle, WA, and Philadelphia, PA.
Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to
achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.
You have experience in clinical research and you want to make a difference by helping to improve people's quality of life? Our opportunity will surely interest you! As a fast-growing contract research organization, you will have the opportunity to develop your skills and advance in your career. If you stand out for your contribution within a team, your organizational skills and your attention to details; don't hesitate to send us your resume!
The Clinical Research Associate (CRA) will report to the Director, Monitoring Services. The CRA will perform monitoring and site management activities for clinical research projects to assess the progress of clinical projects at assigned investigative sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Clinical Monitoring Plan, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.
• Identify investigators;
• Create Clinical Monitoring Plans (CMP);
• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance;
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and CMP;
• Assesses site processes;
• Conducts Source Document Review of appropriate site source documents and medical records;
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records;
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines;
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required/appropriate;
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness;
• Perform investigational product (IP) inventory, reconciliation and reviews storage and security;
• Facilitate audits and audit resolution;
• Process and track SAEs;
• Review study protocols and Informed Consent forms;
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Minimum of 2 years of clinical research related experience, of which a period of 6 months is preferable in clinical research monitoring or equivalent experience;
• Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred;
• Knowledge of clinical research industry, terminology and practices;
• Knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
• Strong verbal and written communication skills;
• Familiarity with EDC systems; ability to learn required systems quickly and to train others, especially site staff;
• Ability to meet deadlines, multitasks, and prioritize based on study needs;
• Ability to make sound decisions based on available information;
• Ability to establish and maintain a good working relationship with site personnel/ colleagues;
• Ability to work both in a team and independently;
• Ability to facilitate team meetings and teleconferences;
• Ability to present at internal study team meeting(s);
• Proficient with Microsoft Office Word, Excel and Power Point;
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines;
• Ability to travel.
Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
- Job Family Valide Positions
- Pay Type Salary
- Laval, QC, Canada
- Montreal, QC, Canada