Coordinating Cra

hace 5 meses

Buenos Aires, Argentina Novasyte A tiempo completo

Coordinating CRA (CCRA)

PURPOSE OF THE ROLE

To take the lead on behalf of the CFSP Clinical Monitoring department, as representative on the Study Team for our function. Responsible for operational management of a team of Monitors from start up, to ensure consistent monitoring quality and adherence to Trial timelines across all regions, through to database lock and site closures.

MAIN INTERFACES
- Internally: All members of CFSP Clinical Monitoring team, the Senior Global Trial Manager (SGTM) and members of the Study Team.
- Externally: Sponsors, Vendors and suppliers as appropriate.

KEY TASKS & RESPONSIBILITIES

While projects vary, the typical responsibilities might include:

- Monitor Study Progress and Follow-up on Outstanding Items and Actions
- Manage Site Quality and CQRMP Process
- Support Clinical Team with Monitoring Delivery and Site Issues
- Develop Study Specific Training Tools/Content for IQVIA members - CRA, DLM and Site Report Specialist
- Initial Point of Contact for CRA Team
- Manage Compliance with Monitoring Plan and Study Procedures & Oversee Trip Report Review Process with SRS Team
- Lead CRA Team Meetings

Drive the following:
- Collection, input and communication of review of required study documentation (e.g. SMP.) and implementation of documents on a global level.- Provide information to the SGTM and communicate information from the Trial Team to the CFSP Clinical Monitoring group and management.- Validation and Follow-up of Key Study Milestones (e.g. start-up timeframe, recruitment targets, data collection, data cleaning, database closure) to be performed by all Monitors.- Organization of initial and refresher monitor training meetings with Trial Team in preparation for site selection and evaluation phase and subsequent trial phases (if deemed necessary e.g. Monitoring Close out).- All Site Management activities (including constant feedback to the study team).- Responds to any Monitors questions and provides feedback, participates initiation visits, monitoring visits and close out visits as assigned or as necessary.- Managing a Question and Answer Log for all monitor queries and issues.- Review trends and provide comments on the centralised review of all Evaluation, Site initiation, Monitoring and Termination Visit reports.- Participate actively in Investigator Meetings (e.g. present CRF, GCP, monitoring planning and conventions and other study related procedures) if requested by Sponsor.- In conjunction with the SGTM, manage the TMF progress actively in order to have the TMF inspection ready at any time.- Acts as a communication channel to and from Monitors to ensure site management and site quality is maintained to all required regulatory and ethical standards throughout the study and provide regular feedback to the GTM and Study Team (as outlined in Communication/Escalation Plan).- Review and provide input on requested trial documentation, as allocated on the delegation of activities form:
- Coordinate the generation and input of study related forms in accordance with standard templates (e.g. investigator selection customize site evaluation/assessment reports)- Organise CSFP Clinical Monitor conference calls (meetings if needed) in order to achieve study targets and provide training. In addition, track attendance, generate meeting minutes in a timely manner and file any presentations given- Adapt and maintain GCM study tools incorporating the Monitors’, SGTM and Study Team’s input: E.g. CRF Completion and Monitoring conventions; Monitoring Plan ;additional tracking tools and/or reports generated.- Study communication tool development and/or input (e.g. newsletter, Q&A document, submissions manual, submission related tools)- Finalization and implementation of site initiation activity plans:
- Classify issues, handle clinical issues, during data cleaning and query resolution and escalate appropriately. Track progress of data cleaning and identify quality trends.-
- In conjunction with the DLMs and the SGTM, develop a resourcing plan for the monitoring activities and follow up-
- Analyse and review the KPIs with respect to the monitoring quality aspects and trial related timelinesEDUCATION/LANGUAGES- Advanced degree or equivalent education/degree in life science/healthcare recommended.- Excellent command of English.

PROFESSIONAL SKILLS & EXPERIENCE- At least 6 years working under CRA role.- Project Centric Delivery- Working with People- Adaptability/ Flexibility- Quality Management- Critical Thinking- Site Focus- Ownership/ Accountability- Proficient in multiculturalism- Ability to drive Change and Innovation- Strong results orientation

ROLE CONDITIONS:
- This is a role, not a job.- No direct reports.- Office based/Home based in Buenos Aires and/ or Mexico city- Reduced number of visits at the site.- Reporting to Dedicated Line Manager.- Department: Clinical Functional Service Provider (CFSP), R&DS

IQVIA is a leading global provider of advanced analytics, technology solu

  • Coordinating Cra

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Coordinating Cra

    hace 6 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Job Overview Perform monitoring and site management work for a variety of protocols, site and therapeutic areas. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International...

  • Clinical Trial Operations Coordinator

    hace 4 semanas

    Buenos Aires, Buenos Aires C.F., Argentina CDS Fortrea Inc. A tiempo completo

    Clinical Trial Operations Coordinator RoleAt CDS Fortrea Inc., we are seeking a skilled Clinical Trial Operations Coordinator to join our team. This role will be responsible for coordinating clinical trial operations, ensuring the smooth execution of studies, and maintaining strong relationships with investigative sites and project teams.Key...

  • Senior Clinical Research Associate, Argentina, IQVIA Biotech

    hace 6 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    IQVIA Biotech is hiring in Argentina! Join our team as a Senior Clinical Research Associate. The ideal candidate will have varied therapeutic experience and be willing to working across multiple therapeutics including: Oncology, Cardiovascular, Internal Medicine, & ophthalmology. This role will be home-based in Buenos Aires, Argentina. ​ BASIC FUNCTIONS:...

  • Site Management Associate I

    hace 2 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    **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 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to...

  • Senior Clinical Research Associate

    hace 3 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    **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

    hace 6 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    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 those...

  • Senior Clinical Research Associate

    hace 3 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Job DescriptionHome-based position in ArgentinaOnly CV's in English will be consideredWe are looking for an experienced CRA ready to train and coordinate junior CRAs on site. Here you will have the opportunity to develop yourself as a trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and...

  • Site Management Associate I

    hace 6 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Job 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: Being the main point of contact between site personnel and CRA involved in the project helping on query...

  • Senior Clinical Research Associate

    hace 5 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    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 those...

  • Site Management Associate I.

    hace 6 meses

    Buenos Aires, Argentina PSI A tiempo completo

    Job 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: Being the main point of contact between site personnel and CRA involved in the project helping...

  • Clinical Team Lead

    hace 6 meses

    Buenos Aires, Argentina Fortrea - Organic A tiempo completo

    Trial Preparation, Conduct and Closeout: 1. Selects sites, conducts and delivers the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP, procedures and all other relevant applicable regulations. 2. Perform/supervise local adaptation of the required documents for submission according to the package provided...

  • Site Operations Coordinator

    hace 2 semanas

    Buenos Aires, Buenos Aires C.F., Argentina PSI A tiempo completo

    About PSIPSI is a leading global company in the field of clinical research, and we are seeking a highly skilled Site Management Associate I to join our team.Job DescriptionThe ideal candidate will have excellent communication skills and experience working in an international setting. The role involves providing key support to clinical research projects by...

  • Senior Clinical Research Associate, Argentina, Biotech

    hace 1 mes

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job SummaryWe are seeking a highly skilled Senior Clinical Research Associate to join our team in Argentina. As a Senior Clinical Research Associate, you will be responsible for participating in the preparation and execution of Phase I-IV clinical trials, overseeing the progress of clinical investigations, and monitoring clinical trials in accordance with...

  • Regional Clinical Supply Pharmacist

    hace 6 meses

    Buenos Aires, Argentina Pfizer A tiempo completo

    Why Patients Need You The Regional Clinical Supply Pharmacist is responsible for developing, coordinating, and executing the clinical supply strategy across Latin America (LATAM) region for local and global studies involving clinical sites including Investigational Product (IP) supply, logistics, and training. This role will have multiple responsibilities...