Clinical Research Associate
hace 2 semanas
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The role is accountable for performance and compliance for assigned protocols and sites in Argentina.
Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expand the territory for clinical research, finding and developing new sites.
Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Main responsibilities:
- 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 records 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 CRA manager, CRM, and RCPM.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed
- Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities
Core Competency Expectations:
- Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyse data/metrics and act appropriately
- Behavioural Competency Expectations:
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
- Able to work highly independently across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Works with high quality and compliance mind-set
**Requirements**:
- Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
- B.A./B.S. with strong emphasis in science an
-
Sr. Clinical Research Associate
hace 3 días
Munro, Argentina MSD A tiempo completoAre you an experienced Clinical Research Associate looking for a new opportunity to excel in your career? Join our dynamic team and make a difference in the field of clinical research. We are seeking a highly motivated and detail-oriented individual to oversee and manage clinical research protocols and sites in Argentina. As a Clinical Research Associate,...
-
Clinical Research Associate
hace 5 días
Munro, Argentina MSD A tiempo completo**Job Description**: Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill,...
-
Clinical Research Associate
hace 10 horas
Munro, Argentina MSD A tiempo completoOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and...
-
Sr. Spclst, Clinical Research
hace 1 semana
Munro, Argentina MSD A tiempo completo**Job Description**: Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill,...
-
(Finance) Clinical Trial Coordinator
hace 10 horas
Munro, Argentina MSD A tiempo completoUnder the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The role is critical to meet planned Site Ready dates. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with...
-
Reports Programmer
hace 6 días
Munro, Argentina MSD A tiempo completo**Job Description**: Our organization is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination,...
-
Cra
hace 10 horas
Munro, Argentina MSD A tiempo completoThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company´s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...
-
Msl General Medicine
hace 1 día
Munro, Argentina MSD A tiempo completoMedical Science Liaison Specialist (MSL Specialist) is a credentialed therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. The role provides scientific leaders (SLs) balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific...
-
Cra Junior
hace 10 horas
Munro, Argentina MSD A tiempo completoWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking 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...
-
Lead Clinical Database Testing Analyst
hace 2 semanas
Munro, Argentina MSD A tiempo completo#ONEGDMS **Position Overview** Under the direction of the Director/Associate Director, the Lead CDT Analyst creates and executes Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture (EDC) systems. This includes: internet based EDC, electronic devices, electronic diaries, IVRS/IWRS, etc. along with reporting...
-
Reports Programmer Analyst
hace 1 día
Munro, Argentina MSD A tiempo completo**Job Description**: Skills) - Job Description In Primary Posting Language (Include Requirements For Education, Experience And Skills) Primary activities include, but are not limited to: Assumes the responsibilities for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs. Coordinates...
-
Ram Mapping Programmer Ii
hace 2 días
Munro, Argentina MSD A tiempo completoPrimary activities include, but are not limited to: Assumes the responsibilities for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs. Coordinates and participates in the following activities: 30% Design, build, maintain, test, and document data mapping specifications based on...
-
Cra Manager
hace 7 días
Munro, Argentina MSD A tiempo completoThis role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is...
-
Medical Science Liaison
hace 10 horas
Munro, Argentina Bayer A tiempo completo**Medical Science Liaison (MSL) Oncology** At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where, Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us,...
-
Medical Science Liaison
hace 10 horas
Munro, Argentina Bayer A tiempo completo**Medical Science Liaison (MSL) Cardio Renal** At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where, Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around...
-
Edao Analyst Ii
hace 2 días
Munro, Argentina MSD A tiempo completo**Job Description**: Create, review, and facilitate approval of external data format specification documents for new vendors and data types. Coordinate with external vendors, Information Technology (IT), and the other supporting functions to validate external data transfers into our organization’s data management system in accordance with detailed...
-
Edao Analyst
hace 10 horas
Munro, Argentina MSD A tiempo completo**Job Description**: **Reporting directly to Head/Manager of eClinical Technologies, the EDAO Analyst** will create, review, and facilitate approval of external data format specification documents including, but not limited to; Data Transfer Specifications (DTS) & Electronic Data Transfer (eDT). Coordinate with external vendors, Information Technology (IT),...
-
Admin Assistant Iv
hace 7 días
Munro, Argentina IGT A tiempo completoLocation: Munro, AR, 1605- Requisition ID: 10863**Responsibilities**: - Provides analytical and specialized administrative support to relieve executive, administrative, and line and staff managers of complex details and advanced administrative duties. - Executes special or continuous research and data analysis tasks. - Analyzes problems, determines...
-
Sr. Business Platform Lead
hace 3 semanas
Munro, Argentina MSD A tiempo completoLead projects that deliver high value technical solutions that meets clinical business needs and organization adoption. - Arranges, facilitates and schedules meetings, demos and decision-making processes to ensure that the proper collaborative process is in use - Documents complex process flows and creates user requirements and user testing scenarios....
-
Cdt Analyst Ii
hace 4 días
Munro, Argentina MSD A tiempo completoUnder the direction of the Director/Associate Director, the CDT Analyst II creates and executes Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture (EDC) systems. This includes: internet based EDC, electronic devices, electronic diaries, IVRS/IWRS, etc. along with reporting and documenting testing results....