Clinical Research Associate
3 semanas atrás
About the Role
We 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 practices, and applicable regulatory requirements while meeting quality and timeline metrics.
Key Responsibilities:
- Complete appropriate role-specific training to perform job duties.
- Under supervision, provide study-level administrative support to the clinical study management team (examples of such tasks include, but are not limited to, running system reports, preparing and distributing status reports, creating and maintaining study trackers, follow-up for outstanding issues, etc.).
- Assist in updating and maintaining systems within project timelines/plans and drive tracking compliance in various systems to enable credible data for analysis.
- Perform activities as per the task list delegated by CMS leads.
- Assist CMs in the preparation of i-site packs for their respective sites and countries for assigned studies, by pulling associated reports.
- Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs, respective regulations, and guidelines.
- Prepare i-site packs for respective sites and countries for assigned studies.
- Interact with sites/CRA and follow up on missing data, pending queries, SDV backlog, visit schedules, PD, etc.
- Establish and maintain effective project/site communication.
- Assist leads in maintenance of internal systems, databases, tracking tools, and project plans.
- Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plans, review, triage, and action clinical study alerts, monitor clinical operation plan (COP) compliance, etc.).
- Perform Subject Level Data Review that requires further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/IP/AE/Labs/EOT/EOS/End points/SAEs, etc.). Review any other information as necessary to determine overall readiness of the patient information for the next level review.
- Perform study-specific analytics based on applicable study-specific plans.
- Perform assigned access management related administrative tasks to support team members with project execution, examples of tasks include, but are not limited to, processing access requests, following up with relevant vendors, assigning catalog tasks to process associates, etc.
- Act as a backup for Centralized Monitors/Sr. Centralized Monitors.
- Provide support to the technical solution specialist (TSS) on formulations in Excel, automation of tools using macro codes, and designing of the tool on the front end and back end.
- Facilitate early identification of site-level risks/issues occurring during study conduct and be responsible for the identification of risk.
- Monitor site performance and make recommendations for timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit).
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.
- Review the Study Central Monitoring Plan.
- Adhere to the key activities outlined in the SOW as per customer requirements.
Qualifications
- To be located in Argentina, Mexico, Brazil, Colombia, or Peru – it is a home-based role.
- Bachelor’s degree in Life Sciences (if you don’t have it, it can be compensated if you have a strong clinical background as a Study Coordinator, for example).
- Advanced level of written and spoken English (it will be evaluated).
- Previous experience in Clinical Research in a CRO, site, or pharma.
- Knowledge of Excel.
- Availability to join Mid-January 2025.
Salary Range: $60,000-$80,000 Per Year
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