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Lead the development of the protocol and related documents and the development and delivery of the clinical study report to meet GCP, ICH and all AstraZeneca quality standards. Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Velocitys SOPs.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Completes and oversees analysis of protocol documents to generate study database design specifications including CRF/eCRF design, visit schedule, edit checks, system notifications, query logic, user role setup, randomization triggers, supply triggers, and medical coding.
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Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports. In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects.
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Be available to complete mandatory web-based home study training sessions before in-person training. The primary role is to review medical records in a sampled hospital's emergency department(s), abstract specific information from the patient's chart following the project's case identification protocol, and entering the information into a data collection tool.
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Conduct clinical research according to approved protocols as a study Principal Investigator, Protocol Chair, Associate Investigator, Consultant, or other designated role and maintain ethical and regulatory compliance as well as the integrity of study data and health and welfare of study participants.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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KEY RESPONSIBILITIES IN DETAILManages the team of Clinical Science Leads (CSLs) and Senior Clinical Science Leads (SCSLs), assigned to the development program, who lead the clinical matrix teams responsible for clinical study activities, including study design, protocol development, input into statistical analysis plans, medical data cleaning and reconciliation, data analysis and interpretation, in compliance with Good Clinical Practice (GCP) and GSK policies and procedures.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Ad- Hoc Work products and documents related to independent plasmid design, engineering, protocol execution, and validation of Client CRISPR tools - Ad-Hoc Work Details: Independently design, troubleshoot, and carry out various molecular cloning experiments related to CRISPR nterference tool development and iPSC differentiation.
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Contributes to the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Investigator. HJF is seeking a Research Protocol Coordinator I, II, or III (multiple openings) to support the Murtha Cancer Center Research Program (MCCRP) located at the Rockledge Office in Bethesda, MD. The mission of MCCRP is to improve the diagnosis and multidisciplinary treatment of DoD cancer patients through innovative translational research, evidence-based translational care, and education.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Assist with the collection of study data as required by the study protocol, specifically the CBH screening form, admission forms and release of information. Complete other study procedures such as weight/height, waist/hip circumference as specified on the appropriate flow sheets.
Part-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Perform research/regulatory site administrator duties for new clinical protocol including: preparing/coordinating site visit conducted by sponsor/study monitors for study start-up; coordinating study team meetings; addressing questions and requests for documentation from internal and external sources related to the scientific review, development of consents and submission of protocol to NIH IRB; drafting Research Plan for RCA and CRADA (including budget) documents for Tech Transfer office.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
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Candidates are expected to have clinical research oversight expertise in mental health research with the ability to provide expert advice and consultation as needed on NIMH initiatives for clinical research studies and clinical trials including the scope, design, research study operations, human research protections and relevant federal regulation, data and safety monitoring, good clinical practive, and protocol compliance montoring.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Provides operations and strategic input and/or approves study documents such as synopsis, protocol, ICF, eCRFs, eCRF Completion Guidelines, Study Plans and Manuals, and Clinical Study Report development, etc.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Ensures, reviews, and quality controls against associated project protocol, NIAID requirements, CRF standards templates, Good Clinical Data Management Practices (GCDMP), and where applicable CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards.
$86,000 - $134,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago
protocol study jobs in Rockville, MD
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