Syneos Health

Clinical Research Associate II, CVD Experience Preferred

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇮🇳 India

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Job Level

JuniorMid-Level

Tech Stack

Google Cloud Platform

About the role

  • Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)
  • Act as one of the points of contact at a Site level for internal and external stakeholders
  • Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders
  • Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials
  • Develop Site relationships (incl. Contract Research Organization related issue management and non-registrational/Investigator Sponsored Research Studies)
  • Recommends sites during the site feasibility and/or site selection process
  • Conducts pre-study visit as appropriate
  • Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation
  • Reviews site activities and quality through on-site and off-site visits
  • Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable
  • Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
  • While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions
  • Serve as a point of contact for Sites
  • Provides trainings to sites
  • Performs site closure activities when all required protocol visits and follow-up are completed
  • Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
  • Ensures completeness and quality of data submitted from study sites
  • Oversees activities of site personnel over whom there is no direct authority
  • Motivates/influences the site to meet study objectives, including enrolment and retention goals
  • Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
  • Anticipates, identifies and proactively supports site in resolving issues as they occur
  • Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team
  • Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
  • Involvement in Regulatory Compliance audit/inspection process, as needed
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
  • May support Ethics Committee submission, ICF review, collection of documents to/from site
  • May support ensuring access to eDC and client/vendor systems is available for clinical trial site personnel
  • May support equipment calibration and tracking
  • May support preparation of Study Initiation Visit materials
  • May support coordination and ensure database lock timelines are met as required locally

Requirements

  • Bachelor's degree required, preferably within Life Sciences or equivalent
  • Master's degree in Pharmacy/Life Sciences preferred
  • 3+ years of relevant clinical research experience, with at least one year previous monitoring experience is required, able to work independently
  • 3-4 years of onsite monitoring experience preferred
  • Has basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials
  • Experience in the drug discovery/development process
  • Knowledge and understanding of clinical research processes, regulations and methodology
  • Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
  • Organization and time management skills
  • Ability to build, maintain and strengthen relationships even under pressure and/or in difficult situations
  • Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator
Benefits
  • Career development and progression
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition and total rewards program

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial oversightmonitoring activitiesdata assessmentprotocol specific trainingsite feasibility assessmentregulatory complianceroot cause analysisdrug discovery processclinical research methodologyICH/GCP Guidelines
Soft skills
relationship buildingflexibilityadaptabilityproblem-solvingcommunicationorganizationtime managementinfluencemotivationindependence