Clinical Research Associate - Ohio/Michigan
Title: Clinical Research Associate This role is located in either Ohio or Michigan. The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. Responsibilities: Contributes to the selection of potential investigators. In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. Actively participates in Local Study Team (LST) meetings. Contributes to National Investigators meetings, as applicable. Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. Updates CTMS and other systems with data from study sites as per required timelines. Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits. Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. Ensures data query resolution in a timely manner. Works with data management to ensure robust quality of the collected study data. Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP. Follows up on outstanding actions with study sites to ensure resolution in a timely manner. Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required. Assists site in maintaining inspection ready ISF. Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM. Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate. Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF. Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). Ensures compliance with local, national and regional legislation, as applicable. Collaborates with local MSLs as directed by LSM or line manager. Requirements: Bachelors degree in related discipline, preferably in life science, or equivalent qualification (*). Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. Good knowledge of relevant local regulations. Good medical knowledge and ability to learn relevant AZ Therapeutic Areas. Basic understanding of the drug development process. Good understanding of Clinical Study Management including monitoring, study drug handling and data management. Excellent attention to details. Good written and verbal communication skills. Good collaboration and interpersonal skills. Good negotiation skills. Ability to travel nationally/internationally as required. Valid driving license Salary: The annual base pay for this position ranges from $112,154.40 - $168,231.60. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Cell Therapy Site Management & Monitoring