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Manage aspects of the study related to ratings with the rater training representative, study sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
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Reads protocol and develops systems for screening and coordinate scheduling patients per study visits. Consults with PI and the Research Nurse Manager regarding ongoing study assignments.
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Enters research study data into paper or electronic case report forms (CRFs) or local data systems as required, in accordance with protocol requirements and departmental timelines. · Coordinates with research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting, and protocol deviations or violations.
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Collects, processes and ships protocol-required lab specimens; maintains supply and equipment inventory; maintains appropriate laboratory certification as well as perform study closeout procedures including post-study documentation, return of study materials to the sponsor and data archiving.
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Oversees study intake, creation of individual study budgets for CRU, implementation, and ongoing study conduct within the CRU with full adherence to patient safety standards, protocol instructions, and clinical research rules and regulations.
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Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
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Substantial clinical study protocol experience, as lead author, required. Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.
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Volunteering to take part in the trial and following the study protocol. Collaborating with the investigator and study coordinator) to ensure the smooth running of the trial. Collaborating with the investigator and study coordinator) to ensure the smooth running of the trial.
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Be compliant with infection control procedures and environmental safety protocol within a facility. Build a strong occupational therapy programEnhance clinical expertise, professional and management skills through interaction with managers, therapists and other professional staff, self-study, and other continuing education activities.
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Senior Manager, Marketing Database -Therapeutics This position plays a crucial role in identifying potential study candidates within our therapeutics patient database. Collaborate with research teams to clarify any medical or protocol-related queries.
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In collaboration with the research nurse/clinical study coordinator from various teams, conduct routine monitoring in accordance with departmental quality assurance SOPs. The primary purpose of the Sr. Research Data Coordinator position is to collaborate with the principal investigator(s) and the research team(s) in preparing research protocols, assuring protocol compliance, collecting protocol specific information utilizing a computer database system and communicating with patients and staff regarding protocol information, and carry out research projects.
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Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases.
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For MD Anderson Sponsored trials, represents the sponsor (MD Anderson), in study initiation activities, ongoing protocol visits, and study closeout activities. Participates in the development of and/or review of study related documents (Protocol, Informed Consent, CRFs, Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.
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Build and implement patient engagement and recruitment strategies based on each study protocol. Hands-on, data driven coaching including creating and tracking KPIs, education on protocol, appropriate documentation, and management to improve areas of underperformance and/or prevent underperformance.
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Follow policies and procedures per approved study protocol. Technical interface between study sponsor and clinical site staff. Clinical site engagement, ensuring documentation is filed and organized in a timely manner, per protocol.
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protocol study jobs in Houston, TX
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