Clinical Trial Assistant
3 semanas atrás
Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Essential Functions
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
- Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of study files for completeness.
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
**Qualifications**:
- High School Diploma or equivalent Req
- 3 years administrative support experience.
- r.
- Equivalent combination of education, training and experience.
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
- Written and verbal communication skills including good command of English language.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
-
Clinical Trials Assistant 1
1 semana atrás
São Paulo, Brasil IQVIA Tempo inteiroJob Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...
-
Clinical Trial Assistant
4 semanas atrás
Sao Paulo, Brasil Medpace, Inc. Tempo inteiroJob Summary: Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We...
-
Clinical Trial Manager
4 semanas atrás
Sao Paulo, Brasil Novasyte Tempo inteiroClinical Trial Manager - Sponsor Dedicated. Trial Management services provide local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end project management from start-up through to closeout...
-
Sao Paulo, Brasil BeiGene Tempo inteiroPLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION Language Requirement: Fluent English and Portuguese. Spanish is a plus. Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology Company Overview: BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on...
-
Clin Trials Assistant
4 semanas atrás
São Paulo, Brasil Fortrea Tempo inteiroAs 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...
-
Clinical Trial Operations Manager
Há 1 mês
Sao Paulo, Brasil BeiGene Tempo inteiroPLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION Language Requirement: Fluent English and Portuguese. Spanish is a plus. Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology Company Overview: BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on...
-
Clinical Quality Associate I
Há 1 mês
Sao Paulo, Brasil Curebase Tempo inteiro**About the role**: Curebase is seeking a Clinical Quality Associate I who will thrive in a quickly scaling healthcare technology environment. Quality at Curebase is deeply cross-functional, and you will work with nearly every function at the company to conduct risk-based quality management (RBQM) surveillance of Clinical Operations activities at Curebase....
-
Clinical Trial Manager
Há 7 horas
Sao Paulo, Brasil Medpace, Inc. Tempo inteiroJob Summary: Medpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers / Project Managers to join our Clinical Trial Management Group in **Sao Paulo, Brazil**. Our therapeutic areas of focus include Oncology, Cardiovascular/Metabolic, Infectious Disease, CNS and more. We provide remote flexibility with...
-
Clinical Trial Manager
4 semanas atrás
São Paulo, Brasil IQVIA Tempo inteiroClinical Trial Manager The Clinical Trial Manager provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in...
-
Clinical Trial Administrator Ii
4 semanas atrás
Sao Paulo, Brasil PSI CRO Tempo inteiro**Company Description** PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Join our international team and be the key support to...
-
São Paulo, Brasil IQVIA Tempo inteiroPURPOSE Manages complex regulatory projects and programs and supports more junior members of the team. RESPONSIBILITIES Acts as a Clinical Trials Regulatory Manager (CTRM) on complex clinical trial projects/programs and may act as a Regulatory Oversight for a key customer. May act as a Project Manager on stand-alone projects Ability to...
-
São Paulo, Brasil BeiGene Tempo inteiroBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR...
-
Freelance Motion Designer
4 semanas atrás
Sao Paulo, Brasil Clinical Research Brazil Tempo inteiroECLEVAR MEDTECH is a clinical research organization focused on MEDTECH. The company delivers clinical trials on behalf of the sponsor by leveraging real-world evidence data. The company develops internally digital health software that connects the healthcare ecosystem. JOB TYPE: Freelance LOCATION: Remote - Work from anywhere Create a video of 2/3 min for...
-
Clinical Trial Administrator II
4 semanas atrás
São Paulo, Brasil PSI CRO Tempo inteiroJob DescriptionJoin our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. Only CVs in English will be accepted.You will be responsible for:Customization of Site ICF/patient documents before sending it to sites;EC- IRB submissions;Site Room, Veeva...
-
Clinical Trial Administrator II.
4 semanas atrás
São Paulo, Brasil PSI Tempo inteiroJob Description Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. Only CVs in English will be accepted. You will be responsible for: Customization of Site ICF/patient documents before sending it to sites; EC- IRB submissions; ...
-
Research Assistant
4 semanas atrás
Sao Paulo, Brasil Novasyte Tempo inteiroEssential Functions - Provide clinical research support to investigators and site staff, including - Verify and/or correct research study information on source documents; research queries and variances; and provide feedback to the site data collector. - Input research study data into trial Electronic Data Capture (EDC) system, maintaining quality control...
-
Clinical Trial Scientst
Há 1 mês
Sao Paulo, Brasil Bayer Tempo inteiro**Clinical Trial Scientst / Pharmaceuticals / São Paulo - SP / Hybrid Model** YOUR MISSION WILL BE TO: - Medical Data Review Plan - Prepare a medical data review plan with input and review by relevant stakeholders (Clinical Leaders, CPM, StM, DM) - Safety Tables, Figures, and Listings (TFLs): Facilitates the development of a study-specific Table of...
-
Initiation Clinical Research Associate I
4 semanas atrás
Sao Paulo, Brasil Parexel Tempo inteiroWorking from home with occasional days in our office location in Sao Paulo, as an Initiation Clinical Research Associate (ICRA) you will be the direct point of contact with assigned sites located throughout South America and accountable for quality and delivery during the start-up phase. Duties will include EC submissions / site activation related...
-
Clinical Trial Coordinator
4 semanas atrás
São Paulo, Brasil Fortrea Tempo inteiroRequirements: Completed job training (finance), or Bachelor’s Degree 1-2 years of experience in Finance of clinical trials (focused on site payments); Advanced English Advanced Excel Hands-on Attention to details Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the...
-
Clinical Operations Manager
Há 1 mês
São Paulo, Brasil Fortrea Tempo inteiroAs 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...