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Clinical Research Associate

3 months ago

Haridwar, India Lifelancer Full time

About thejob

A Clinical Research Associate(CRA) is a professional who plays a critical role in the field ofclinical research. Their primary responsibility is to ensure thatclinical trials are conducted in accordance with applicableregulations guidelines and protocols.

KeyResponsibilities

  • Protocol Compliance: Ensure that clinical trials are conductedaccording to the approved study protocols Standard OperatingProcedures (SOPs) Good Clinical Practice (GCP) and applicableregulatory requirements.
  • Site Selection andInitiation: Identify and evaluate potential investigational sitesfor participation in clinical trials. Conduct site initiationvisits train site staff on protocol requirements and ensure allnecessary documentation is in place.
  • Monitoring: Perform routine monitoring visits to assigned sites toverify the integrity of clinical data and ensure compliance withstudy procedures. Collect review and verify source documentationand case report forms (CRFs) for accuracy andcompleteness.
  • Data Management: Collaboratewith data management personnel to ensure accurate and timely datacollection reporting and resolution of data queries. Review datalistings and tables to identify discrepancies orinconsistencies.
  • Safety Reporting: Monitor andreport adverse events (AEs) and serious adverse events (SAEs) tothe sponsor ethics committees and regulatory authorities asrequired by regulations and protocols.
  • Regulatory Compliance: Ensure that all required regulatory andethics committee submissions are completed accurately and in atimely manner. Assist in the preparation and review of regulatorydocuments such as clinical trial applications and informed consentforms.
  • Documentation and Record Keeping:Maintain trialrelated documentation including study files essentialdocuments and correspondence. Ensure that all trialrelatedmaterials are complete organized and storedsecurely.
  • Relationship Management: Establishand maintain effective relationships with investigators studycoordinators and site personnel to facilitate study conduct andaddress any issues or concerns that arise during thetrial.
  • Study Closeout: Conduct site closeoutvisits and ensure that all required study documentation andsupplies are returned to the sponsor or properly archived. Assistin the preparation of study reports and final study data forsubmission to regulatory authorities.
  • Continuous Learning: Stay updated on relevant regulationsguidelines and industry best practices. Attend training sessionsand professional conferences to enhance knowledge and skills inclinical research.

Qualifications AndSkills

  • Bachelorsdegree in a scientific or healthcarerelated field (or equivalentexperience) such as MSc. Clinical Research M. Pharm Pharm D medicaland Paramedical degree.
  • Strong knowledge ofGood Clinical Practice (GCP) guidelines and relevant regulatoryrequirements (e.g. FDA ICH).
  • Prior experienceworking as a Clinical Research Associate or in a related role ispreferred.
  • Excellent organizationalcommunication and interpersonal skills.
  • Attention to detail and ability to work independently and as partof a team.
  • Proficiency in using clinical trialmanagement systems and electronic data capturesystems.
  • Willingness to travel to clinicaltrial sites as needed (domestic andinternational)

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