Clinical Quality Associate I
Há 3 dias
**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. This role places an emphasis on risks impacting patients' safety and data quality to ensure compliance with internal SOPs and applicable regulations (e.g., ICH-GCP, US CFR related to clinical quality). This role reports directly to the Director of Clinical Quality.
**What you'll do**:
- Conduct remote quality reviews of clinical trial data and documentation (e.g., essential documents [i.e., eTMF, eISF], clinical database, training records)
- Document non-compliances (e.g., regulatory, protocol, SOP) and clinical quality issues, ensuring appropriate actions (e.g., quality events, CAPAs)
- Ensure trials are inspection ready at all times in partnership with Clinical Operations
- Participate in activities related to client audits and regulatory inspections
- Participate in the evaluation of external partners (e.g., clinical sites, vendors), including conducting audits (remote or in-person) on an as needed basis
- Contribute to the maintenance of controlled documents related to clinical quality assurance within the Quality Management System
- Assist in tracking of clinical quality compliance metrics to identify risks and trends across clinical trials
- Partner with Clinical Operations in the development of study-level plans related to clinical quality (e.g., Clinical Monitoring Plan)
- Implement and perform study-specific internal clinical quality audit plans as applicable
- Participate in the review and approval of electronic builds for clinical trial protocols
- Contribute to the review of clinical trial documents (e.g., protocol, consent) for quality and regulatory compliance on an as needed basis
- Participate in the implementation of clinical quality improvement initiatives
**About you**:
- Bachelor's degree in life sciences or related field
- Minimum of three (3) years' experience in clinical research, preferably in clinical quality or clinical operations (e.g., Clinical Quality Associate, Clinical Research Coordinator, Regulatory Coordinator)
- Well-versed in relevant ICH-GCP, US CFR, and HIPAA regulations
- Proven ability to work well with a remote-based team
- Clear demonstration of organizational and communication skills
- Ability to excel in a fast-paced and rapidly changing environment
- Demonstrates and recognizes the importance of adaptability and eagerness to learn and adapt to technology changes over time
- Willingness to travel for job-related activities if required (expected travel for this position is < 10%)
**Major pluses**:
- Previous experience working at a startup
- Previous experience working with global teams
**About Curebase**:
Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase's has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community.
This starts with Curebase's leading decentralized clinical trial software platform that is an all-in-one, purpose built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the "BYOP" or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials.
We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients' physical location. COVID-19 tailwinds have created massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide adoption of remote remote research that will only accelerate in the years to come. You can learn more about Curebase and our next stage of growth in Crunchbase, Fierce Biotech, and MedCity News
**Benefits**:
- Passionate team dedicated to making a positive impact
- Unlimited career growth opportunity
- Virtual social and team building events
**Not sure you qualify?**:
Curebase provides equal employment opportuniti
-
Clinical Quality Manager
Há 2 dias
Sao Paulo, Brasil Curebase Tempo inteiro**About the role** Curebase is seeking a Clinical Quality Manager who will thrive in a quickly scaling healthcare technology environment. The Quality and Compliance team at Curebase is deeply collaborative, and you will collaborate with Clinical Operations, while leading and mentoring the Clinical Quality team. This role reports directly to the Director of...
-
Initiation Clinical Research Associate I
1 dia 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 Project Manager
Há 3 dias
Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro**Clinical Project Manager** **(Level Depends on Experience)** **Job Purpose/Summary**: Responsible for management and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client’s goals of time, budget and quality performance are met. The Clinical Project Manager I is expected to require support and guidance from Directors and/or...
-
Clinical Associate
7 meses atrás
Sao Paulo, Brasil Icon plc Tempo inteiroRecognize, exemplify and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration and excellence in delivery. - As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and...
-
Clinical Research Associate I
7 meses atrás
Sao Paulo, Brasil BeiGene Tempo inteiroPLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION 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 molecularly targeted and immuno-oncology cancer therapeutics. With a team of over...
-
Clinical Research Associate I
7 meses atrás
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 Research Associate I
2 semanas atrás
São Paulo, São Paulo, Brasil Fortrea Tempo inteiroCompany OverviewFortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.We...
-
Principal Clinical Research Associate
7 meses atrás
Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro**Principal Clinical Research Associate** **Please submit your CV in English for Quickest Review Process!** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or...
-
Senior Clinical Research Associate I
7 meses atrás
Sao Paulo, Brasil PSI CRO Tempo inteiro**Company Description** We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to...
-
Clinical Research Associate Ii
1 dia atrás
Sao Paulo, Brasil PSI CRO Tempo inteiroCompany 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. Job Description As a Clinical Research Associate II at PSI...
-
Clinical Research Associate
7 meses atrás
Sao Paulo, Brasil AbbVie Tempo inteiro**Company Description** Describe the primary goals, objectives or functions or outputs of this position. To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves studyrelated clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol...
-
Senior Clinical Research Associate
Há 5 dias
Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro**Senior Clinical Research Associate** **(Level dependent on experience)** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved....
-
Senior Regional Clinical Trial Management Associate
2 meses atrás
São Paulo, SP, 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 General Description: - Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical...
-
Oncology Clinical Research Associate
8 meses atrás
Sao Paulo, Brasil AstraZeneca Tempo inteiroAstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients’ lives and benefit society. Our portfolio is solid and our pipeline is...
-
Clinical Trial Management Associate Manager
7 meses atrás
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 Research Associate Manager
2 semanas atrás
São Paulo, São Paulo, Brasil Iqvia Argentina Tempo inteiroJob SummaryWe are seeking a highly skilled Clinical Research Associate (CRA) Manager to join our team at Iqvia Argentina. As a CRA Manager, you will be responsible for overseeing the execution of clinical trials, ensuring compliance with regulatory requirements, and providing guidance to junior CRAs.Key ResponsibilitiesMonitor and manage clinical trial sites...
-
Clinical Research Associate
Há 6 dias
São Paulo, São Paulo, Brasil Iqvia Tempo inteiroAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our team as a Study Monitor. As a key member of our Centralized Monitoring School, you will be responsible for providing project-related assistance to assigned project teams, ensuring all work is conducted in accordance with standard operating procedures, policies, good...
-
Clinical Trial Manager
6 meses atrás
Sao Paulo, Brasil ICON plc Tempo inteiroJob Advert Posting ICON 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...
-
Clinical Research Associate Iii
6 meses atrás
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 Research Associate II
3 semanas atrás
São Paulo, Brasil Parexel International Tempo inteiroIn Parexel we are looking for experienced CRA to make onsite monitoring visits in Brazil. Oncology experience is required. Your time here At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set...