The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
The Clinical Research Associate (CRA) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He or she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.
The Clinical Research Associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The Clinical Research Associate will manage multiple aspects of subjects' welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.
You will monitor and be responsible for the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
CRAs handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.
Skills & Requirements
• Bachelor's Degree or above required in a life science or healthcare discipline.
• 5-10 years of experience in clinical operation.
• Three (3) or more years of experience as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Oncology or autoimmune disease experience
• Should be able to develop/write the protocol independently, write safety summaries, involved in clinical trial design and know how to monitor trials.
• Should also have experience building teams and advise the organization on what is needed as they grow the Clinical Development team.
• Monitoring in rare and complex therapeutic areas, monitoring EDC trials and EHR records Oncology and Autoimmune disease experience or knowledge preferred.
• Relevant site start-up (feasibility, contract negotiations, submissions)
• Monitoring study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Resolving project related problems and prioritize workload to meet deadlines with oversight from management.
You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Hays is an Equal Opportunity Employer.
Drug testing may be required; please contact a recruiter for more information. #1123978