The clinical research associate ii (cra ii) is responsible and accountable for site monitoring and site management. has responsibility for clinical studies according to company, and/or sponsor standard operating procedures, and local regulatory guidelines. assures the implementation of project plans, as assigned. act in the project role of a local project coordinator or lead cra as assigned. essential job duties: 1) the below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties. 2) responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned 3) responsible for all aspects of site management as prescribed in the project plans 4) general on-site monitoring responsibilities 5) ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study 6) ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements 7) ensure the integrity of the data submitted on case report forms (crfs) or other data collection tools by careful source document review 8) monitor data for missing or implausible data 9) ensure the resources of the sponsor and covance are spent wisely by performing the required monitoring...
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Essential job duties: primarily oversees and manages amendment phase of domestic and/or international clinical trials. where required, may also take on start-up tasks under the direction of a project manager, start-up. responsibilities include project managing defined study activities within timelines, scope, quality and budget, ensuring that client’s expectations are met. general lead the team through the amendment phase of a study. responsibilities may also include activating sites in active start-up serve as primary client contact with autonomy to interact directly with the client on a broad range of contract amendment issues and decisions monitor and control project schedule. proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. finance management ensure that work is performed within budget. interpret billing guidelines for the functional area/region and schedule training for start-up team accordingly proactively identify risk of over-spend and track project progress against financial milestones using applicable financial systems. implement and follow pre-approved procedures for write off or budget overages. resource management determine needs, request, and independently manage project start-up resources. adapt/request resources as applicable to ensure project deliverables are met. ensure effective cross-functional teamwork among project team members including both internal and external ancillary services. identify and escalate non-compliance related to maintaining professional stan...
1) the below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties. 2) responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned 3) responsible for all aspects of site management as prescribed in the project plans 4) general on-site monitoring responsibilities 5) ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study 6) ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements 7) ensure the integrity of the data submitted on case report forms (crfs) or other data collection tools by careful source document review 8) monitor data for missing or implausible data 9) ensure the resources of the sponsor and covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to sops and established guidelines, including managing travel expenses in an economical fashion according to covance travel policy 10) ensure audit readiness at the site level 11) travel, including air travel, may be required and is an essential function of the job. 12) prepare accurate and timely trip reports 13) responsible for all aspects of registry management as prescribed in the project...
As a leading global contract research organization (cro) with a passion for scientific rigor and decades of clinical development experience, fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. with over 19,000 staff conducting operations in more than 90 countries, fortrea is transforming drug and device development for partners and patients across the globe. **did you know?** **job summary**: the in-house clinical research associate (ihcra i) is an essential member of a clinical project team responsible for the execution of a clinical research project. the degree of responsibility given to the ihcra i shall reflect their experience, and level of contribution which they can make to the project. the work will involve clinical operations activities which will be conducted in an office or home based setting for designated projects as well as some travel to conduct site visits or to attend client or internal team meetings as needed. the ihcra i will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. activities will be conducted in compliance with company or sponsor sop, regulatory standards and applicable guidelines **experience** minimum required: - at least one year of experience in a related field, (e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing). one ye...
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