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Clinical Research Associate

MDA Edge

Role overview

Qualifications

  • Knowledge of therapeutic areas, particularly oncology and phase 1 studies
  • Experience in regulatory document review
  • Ability to write clinical monitoring plans and source documents
  • Familiarity with ICH/GCP Guidelines and company SOPs

Responsibilities

  • Conducts monitoring/co-monitoring activities for site visits
  • Identifies and documents site findings with corrective actions
  • Verifies study documents for completeness and accuracy
  • Collaborates with data management to resolve queries

Key facts

Hard skills

Clinical Monitoring Oncology Clinical Trial Management Systems Data Integrity Adverse Event Monitoring Query Planning ICH Guidelines

Other skills

  • Communication
  • Collaboration
  • Problem Solving
  • Detail Oriented

About the company

MDA Edge logo

MDA Edge

Business Consulting & Services

Our objective is to establish an exceptional ecosystem by connecting individuals, technology, and prospects through the application of human intelligence.MDA Edge is a process-oriented company and our expertise lies in providing comprehensive Workforce Solutions, specifically focusing on Contingent Staffing, Bulk/Project Staffing, RPO/KPO/BPO, and Direct Hire services. We cater to a wide range of industries, including Infrastructure Consulting, Engineering Consulting, IT Consulting, Healthcare, Life Sciences, Pharmaceutical Consulting, Consumer Goods, Education, Transportation & Logistics, Media & Entertainment, Telecom, BFSI, Manufacturing, Utilities & Energies, and Corporate Recruitment. Moreover, we have developed a dedicated focus on Government Consulting.Our company prides itself on a meticulous approach, ensuring that we meet your specific needs. We have established a robust network of highly skilled professionals who are readily available to fulfill your requirements. With a strong commitment to excellence, we consistently deliver exceptional results for clients in India, Denmark, France, Germany, Ireland, Japan, Spain, Thailand, the USA, Canada and Mexico, with ongoing expansion efforts to serve more new regions in the near future.We consistently uphold the highest standards of quality by providing resources, time, and materials to design, implement, and support efficient operations for organizations. Our track record of measurable accomplishments demonstrates our commitment to cultivating a balanced work and societal ecosystem.Our continuous growth, successful customer engagements, and strong customer retention exemplify our achievements. Furthermore, our passion lies in streamlining complex business processes through the application of suitable technology, which has been integral to our success.We extend an invitation to join our dynamic workplace, offering rapid growth opportunities, excellent employee benefits, and a positive work-life balance.

Company details

Company typeScaleup
IndustryBusiness Consulting & Services
Company size201 - 500

Links

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Job description

Job Summary:
  • Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols.
  • Ensures coordination of interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. This is a contract traveling CRA position if necessary.
Responsibilities:
  • Has a solid knowledge of the therapeutic area or a therapeutic background, showing adeptness to work in oncology and phase 1 studies.
  • Performs regulatory document review and monitors adherence to the regulatory document collection process.
  • Able to write clinical monitoring plans, source documents, and create other study tools when requested.
  • Conducts monitoring/co-monitoring activities for interim site monitoring and closeout visits, in conformance with all relevant laws, regulations, guidelines, protocols, and internal SOPs/policies.
  • Identifies and effectively documents site findings with the ability to re-train, place corrective action in place with the site, and follow up as required.
  • Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
  • Reconciles clinical supplies and drug accountability records at study sites.
  • Identifies and effectively documents site findings with the ability to re-train, place corrective action in place with the site, and follow up as required.
  • Reviews, clarifies, and obtains data changes via query resolutions with site personnel.
  • Collaborates with data management to resolve queries.
  • Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities.
  • Understands and implements processes for distribution and tracking of SAEs, safety documentation, and pregnancies.
  • Monitors compliance with these processes.
  • Facilitates investigator site payments, as applicable.
  • Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.
  • Obtains a complete understanding of all trial-related documents and operational procedures.
  • Maintains clinical trial tracking information pertaining to the study (e.g., monitoring calendar, monitoring reports, phone contacts).
  • Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
  • Reviews and tracks study documents, including project files both electronically and in the Trial Master File and Project Status Reports.
  • Communicates and interacts with relevant study personnel, including developing and maintaining collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to the study manager; troubleshoots and follows up on study progress; and reviews report data for completeness and accuracy.
  • Assists with effective and timely audit/inspection responses.
  • Prepares key reports and documents on the progress of the study for the study manager.
  • Tracks study-specific tasks and progress of the trial.
  • Reviews study and/or site-specific ICF(s) for compliance with ICH/GCP and company SOPs.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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