Senior Clinical Research Ii
hace 3 semanas
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased - Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation
- Pathway as appropriate in collaboration with CRM, CRA-M/PLM.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate
- Is able to support and/or lead audit/inspection activities as needed
- Contribute to initiatives and projects adding value to the business
- Performs co-monitoring as appropriate
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
-
Clinical Research Associate Ii
hace 3 semanas
Buenos Aires, Argentina PSI CRO A tiempo completoCompany 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 those...
-
Clinical Research Associate
hace 2 semanas
Buenos Aires, Argentina PSI CRO A tiempo completoCompany 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 those...
-
Senior Principal Clinical Research Pharmacist
hace 4 semanas
Buenos Aires, Argentina Pfizer A tiempo completoWhy Patients Need You Our Global Clinical Supply (GCS) team ensures that clinical trial patients have the medicines they need when they need them. As a member of Global Clinical Supply (GCS), your dedication will help bringing medicines to the world even faster by embracing challenges, imagining what’s possible and taking action. What You Will...
-
Clinical Trial Administrator Ii
hace 4 semanas
Buenos Aires, Argentina PSI CRO A tiempo completoCompany 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**: Join our international team and be the...
-
Sr Clinical Research Associate I
hace 4 semanas
Buenos Aires, Argentina PSI CRO A tiempo completoCompany 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 those...
-
Experienced Clinical Research Associate
hace 5 días
Buenos Aires, Argentina Medpace, Inc. A tiempo completoJob Summary: Join Medpace in Argentina! The Clinical Research Associate position at Medpace is offering the unique opportunity to have an **exciting career** in the research of drug and medical device development. For those with **medical and/or health/life science interest and background** who want to explore the research field, **travel throughout...
-
Clinical SAS Programmer
hace 2 semanas
Buenos Aires, Argentina Innovaderm Research A tiempo completoThe Clinical SAS Programmer will lead the programming activities for various purposes including SAS Data Listings to be used for data review, Safety Review Listings, Centralized Monitoring Listings and Reports. The Clinical SAS Programmer will also be responsible for productions of Key Risk Indicators, working collaboratively across departments to produce...
-
Senior Clinical Research Associate Ii
hace 4 semanas
Buenos Aires, Argentina PSI CRO A tiempo completoCompany 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 those...
-
Clinical Research Associate Ii
hace 6 días
Buenos Aires, Argentina Labcorp A tiempo completoActs as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP,...
-
Clinical Trial Administrator II.
hace 4 semanas
Buenos Aires, Argentina PSI A tiempo completoJob Description Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. Hybrid position in Buenos Aires, Argentina Only CVs in English will be accepted. You will be responsible for: Customization of Site ICF/patient documents before...
-
Clinical Research Associate I
hace 5 días
Buenos Aires, Argentina PSI CRO A tiempo completoCompany 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 those...
-
Clinical Research Manager
hace 3 semanas
Buenos Aires, Argentina Fortrea A tiempo completoAs 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 Lead
hace 3 semanas
Buenos Aires, Argentina IQVIA A tiempo completoCalling ALL experienced Clinical Leads. The Clinical Lead 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...
-
Buenos Aires, Argentina Lilly A tiempo completoWe’re looking for people who are determined to make life better for people around the world. The Trial Capabilities Associate provides clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing...
-
Clinical Trial Assistant
hace 7 días
Buenos Aires, Argentina Novasyte A tiempo completoJoin us as a Clinical Trials Assistant! - What You´ll DoPerform 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...
-
Senior Clinical Trial Administrator
hace 4 días
Buenos Aires, Argentina PSI CRO A tiempo completoCompany 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**: Join our international team and be the...
-
Clinical Trial Assistant
hace 6 días
Buenos Aires, Argentina IQVIA A tiempo completo**Join us as a **Clinical Trials Assistant!**: **What You´ll Do** 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...
-
Global Clinical Trials Assistant
hace 6 días
Buenos Aires, Argentina IQVIA A tiempo completo**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 Trials Assistant 1
hace 4 semanas
Buenos Aires, Argentina IQVIA A tiempo completo**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...
-
Global Clinical Trials Assistant
hace 5 días
Buenos Aires, Argentina IQVIA A tiempo completoJob 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...