Clinical Research Job Profiles in Various Countries Australia Clinical Research Associate Full project management of a very high priority study, including team management of several regional CRAs to ensure study milestones are achieved. * Responsible for achieving increased global recruitment targets as the highest recruiting region globally. * Managing outsourced vendors who are project managing a multi-centre study * Site management and monitoring responsibilities across multiple therapy areas. Preparing accurate and detailed reports and have the opportunity to lead the training of internal staff on clinical trial practices and monitoring. Clinical Research Coordinator Study coordination for new and existing clinical trials • Data management • Regulatory compliance related to all clinical trial activity Project Manager - Serve as AP Project Mgmt Office Manager and liaise with global contacts • Serve as Senior Project Manager for international (typically intercontinental) projects for one or more clients, according to Covance Standard Operating Procedures, ICH Guidelines and GCP . • Responsible for the successful conduct of assigned projects. • Serve as Senior Project Manager for assigned business development opportunities. • Liaise with senior management in the Delivery and Service Centres to ensure adequate resources are available for assigned projects. • Responsible for on time, on-budget provision of client deliverables for assigned projects • Where appropriate and as assigned, line management responsibility for the training, utilisation, development and performance review of assigned clinical research personnel.
Canada Clinical Research Associate - Management of investigative sites, including site evaluation and selection, start-up activities and initiation, routine on-site monitoring and closeout visits and regular communication to: collect accurate and complete clinical data, verify source documents, collect study documents and ensure compliance with the study protocol and Cangene Corporation’s SOPs, GCP Guidelines and regulatory requirements. - Preparation of site agreements and contracts and financial tracking during study conduct. - Assisting the clinical study team with the development of clinical protocols, case report forms and clinical study reports. - Development of informed consent forms, study documents and study management tools. - Coordinating investigator and study meetings, including preparation and presentation of information and training investigative site staff on protocol, study conduct, GCP Guidelines & regulatory requirements. - Documenting clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with the project timelines, budgets and quality standards. - Management of external contracts and resources including central laboratory and contract research organizations. - Interaction with internal groups including clinical science, data management, pharmacovigilance, shipping/logistics, regulatory affairs, quality assurance and business development during clinical study lifecycle. Clinical Research Coordinator With the support of the Clinical Research Program, Operations Manager, the principal Investigatos (PI) and the Program Leader (PL), the Clinical Research Coordinator will be rsponsible to establish communication and professional relationships with all team members of the Principal Investigator's (PI's) medical team. This will include the Primary Tumor Nurse, Clinical Research Nurse (CRN), all support staff and Co-investigators, which will ensure all aspects of his/her research studies. • Prepare Clinical Trial Submissions for departmental , scientific and ethical review • Co-ordinate investigations • Review patient records for eligibility • Maintain accurate records of all patients on a clinical trial.
• Register/randomize new patients. . • Familiarity with requirements of regulatory codes (FDA, HPB, OCRR, etc.). • Possess sound knowledge and understanding of assigned clinical trials. • Advise the physician and appropriate personnel regarding changes in the trial protocol. • Retrieval of patient specimens, instructs various involved departments of specific procedures. • Preparation/maintenance of statistics. • Other duties as assigned. Project Manager • Pre-clinical Research for a wide variety of projects across the biopharmaceutical and biomedical domain • Continuous oversight of your projects, development of preclinical protocols, and producing preclinical study reports • Communication on an ongoing basis relative to regulatory submission for non-clinical areas • Ensure the collection of accurate and complete preclinical data and ensure compliance with the study protocol and SOPs and other regulatory requirements. • Interact with other scientists relative to the project, as well as staying up to date with the latest literature on preclinical product development. • Management of outsourcing contracts to ensure compliance to protocols and regulations • Design and assist in managing studies in toxicology, pharmacology, pharmacokinetics and pharmacodynamics and other discipline as they relate to preclinical assessment of safety and efficacy.
United States Clinical Research Associate * Create a local culture of accountability, continual learning, best practice sharing and process standardization. * Demonstrated outstanding verbal and written communication skills and abilities, including small and large group presentations. * Demonstrated excellent IT proficiencies; MS Programs: Excel, Word, PowerPoint, EDM Systems, Lotus Notes or similar e-mail program, database utilizations, and web-sharing software. * Proven success with working in a field-based office environment * Ability to work independently and meet deadlines. * Demonstrated ability to effectively work with investigational study site personnel with clinical trial experience strongly preferred. * Excellent organizational skills. * Experienced in the initiation and monitoring of clinical trials per ICH/FDA Guidelines. * Effectively conduct site assessment/new recruitment efforts. * Demonstrated ability to work within a matrix organization. * Experienced in site development and management: setup, monitoring, closeout activities in the conduct of clinical trials. * Demonstrated knowledge of scientific methodology in design and conduct of clinical trials. * Excellent working knowledge of Good Clinical Practice (GCP) regulations. Clinical Research Coordinator * Verifies patient eligibility according to protocols by reviewing medical records, laboratory, and radiology or scan results, and coordinates patient entry onto protocol along with the principal investigator * Obtains the informed consent by educating patients regarding the informed consent process
* Explains the treatment plan, agenda, and patient responsibilities to the patient before they begin the study treatment, and reinforces what the principal investigator has discussed with the patient and documented progress note in medical records * Develops implementation materials for all assigned studies prior to accrual of patients * Interacts with the regulatory department to facilitate submissions, modifications, and renewals of the research protocol to the UPCI Institutional Review Board * Participates in multi-disciplinary meetings to foster professional development * Coordinates initiation, site evaluation, monitoring visits, and audits as required by the sponsor * Meets with the principal investigator to review patient status on a weekly/monthly basis Project Manager * Serve as the main point of contact to the client and provide superior client service. • Direct a team of individuals, assigned to a given project, including other project associates, monitors, data management/statistics and medical writing staff to plan, execute and monitor progress on the study. • Create and monitor metrics on a daily basis to ensure study goals are met. • Oversee the day-to-day work-flow and with sites, labs and other vendors as needed for a given study. • Review research data and work with data management and statistics to evaluate key findings, conclusions and recommendations. • Model Concentrics’ values and guiding principles. • Work closely with the Director of Project Operations to ensure that research goals are met through appropriate staffing and resource needs.
Recommend
More recommend
