Clinical Study Team Assistant I
hace 3 semanas
Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction:- Management and oversight of Study Team shared spaces- TMF maintenance, compliance, and oversight- Analyze, interpret, and follow up on metrics- Management and oversight of Study Management Platform- Analyze, interpret, and follow up on metrics- Registry and/or Clinical Trial Management system(s) compliance and maintenance- Tracking and oversight of study level information; follow up with functional lines as needed- Liaising with cross functional study team members:- Provide study level reporting to support management of clinical trial data, clinical trial budget and timelines- Quality Control (QC) of essential clinical trial, Clinical Study Report (CSR) and regulatory submission documentation- Manages engagement of Independent Oversight Committees- Provides support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities- Assists the CSTL with oversight and tracking of Clinical Trial Budget spend- Provides logístical/operational support to Study Management for Investigator Meetings- Provides status updates on key tasks and activities to the CSTL and contribute to the Core Study Team Meetings as an active Core Study Team member- Works proactively with mínimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes- Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards- On occasion, supports short term Clinical Operations Special Project requests (e.g. workstreams, initiatives, projects)- Manages conflicting priorities to ensure excellent support to assigned study teams with general direction- Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables)- Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training.- Adheres to EP and Client SOPs and processes**Education and Certification**:- Bachelor’s Degree (B.S or B.A) with 0 to 3 years’ experience or Master’s Degree (M.S, M.A or M.B.A) with 0 to 1 years’ experience**Skills and Experience**:- Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research.**Preferred Qualifications**:- Science background- Effective verbal and written communication skills- Ability to work independently but also as part of a larger team with limited support from supervisor- Ability to multitask and manage multiple competing priorities - Has fundamental knowledge of the principles and concepts related to the CSTA role- Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality- Knowledge of drug development process- Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.- Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team to identify and resolve complex problems; Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems**Language Skills**:- Proficiency in written and spoken EnglishLI-REMOTEBack to nav
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Clinical Study Team Assistant I, Fsp
hace 1 semana
Desde casa, México Parexel A tiempo completo**Clinical Study Team Assistant I (CSTA I)****Position Purpose**:The Clinical Study Team Assistant I (CSTA I) is an essential part of the Core Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates with global study team members and...
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Clinical Study Team Assistant I, Fsp
hace 1 semana
Desde casa, México Parexel A tiempo completo**Clinical Study Team Assistant I (CSTA I)** **Position Purpose**: The Clinical Study Team Assistant I (CSTA I) is an essential part of the Core Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates with global study team members...
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Clinical Study Team Assistant I
hace 7 días
Desde casa, México Parexel A tiempo completoParexel is looking for multiple Clinical Study Team Assistant I in Mexico, Argentina or Brazil! The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating...
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Clinical Study Team Assistant I
hace 5 días
Desde casa, México Parexel A tiempo completoParexel is looking for multiple Clinical Study Team Assistant I in Mexico, Argentina or Brazil!The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating...
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Clinical Trials Assistant, Cfsp
hace 3 semanas
Desde casa, México IQVIA A tiempo completo**Job Overview** Perform daily administrative activities in collaboration with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams to ensure the accurate delivery of the Trial Master File (TMF).**Essential Functions**- Assist CRAs and RSU teams with updating and maintaining clinical documents and systems (e.g., TMF) to track site...
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Senior Clinical Research Associate I
hace 5 días
Desde casa, México Parexel A tiempo completo**Parexel FSP is looking for multiple Sr CRAs in Mexico!** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and...
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Study Support Assistant
hace 2 semanas
Desde casa, México ICON A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
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Senior Clinical Research Associate
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**BASIC FUNCTIONS**: Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works...
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Sma I
hace 4 semanas
Desde casa, México ICON A tiempo completoAs a SMA I you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**What you will be doing**:- Supporting Project Manager in quality and data oversight to ensure inspection/audit readiness, including oversight/management of a eTMF- Completion and maintenance of internal...
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Clinical Scientist
hace 7 días
Desde casa, México Parexel A tiempo completo**Primary Location**: Mexico, Remote **Additional Locations**: Argentina, Remote; Brazil, Remote **Job ID** R0000035204 **Category** Clinical Trials **ABOUT THIS ROLE**: **Job Summary** The **Clinical Scientist (CS)**will provide of observational study execution including epidemiological, non-interventional, pragmatic and low-interventional studies and...
