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    • Coordinate clinical trials and research projects from initiation to close-out.
    • Experience in oncology clinical trials will be preferred.
    • Assist in monitoring clinical trial sites and study activities.
    • Ensure compliance with study protocols, GCP (Good Clinical Practice), and regulatory…
    • Candidates will gain hands-on experience in drug safety monitoring, adverse event reporting, and regulatory compliance within the pharmaceutical industry.
    • A CRA ensures that clinical trials are conducted ethically, safely, and in strict compliance with the study protocol and regulatory standards like *Good…
    • Coordinate and manage clinical trial activities.
    • Recruit and screen study participants.
    • Obtain informed consent from participants.
    • Professionals in this field protect public health by monitoring drug safety across clinical trials and post-market use.
    • Pay: Up to ₹340,000.00 per year.
    • Adherence to Ethical Standards: Upholding ethical standards in the conduct of clinical research, including protecting the rights and welfare of research…
    • Coordinate with clinical research teams for data-related activities.
    • Review and validate clinical trial data.
    • Maintain accurate clinical databases and records.
    • MSc Life Sciences / Biotechnology with clinical research experience.
    • Strong scientific understanding and clinical research methodology.
    • The role involves reviewing clinical data, identifying discrepancies, supporting database activities, and collaborating with cross-functional clinical research…
    • Research Decode (https://researchdecode.com/ ) is seeking experienced biomedical researchers to mentor interdisciplinary research projects across life sciences…
    • Stay informed about industry trends and advancements in clinical research.
    • To facilitate and coordinate the all daily clinical research trial activities, for…
    • Required clinical research associates with prior experience of 3 years plus in similar position.
    • Checking documents of CRO internal System audit at specified…
    • Collect and process adverse event (AE) and adverse drug reaction (ADR) reports.
    • Review medical records and safety data for completeness and accuracy.
    • Must have good knowledge of ICH-GCP, New Drugs and Clinical Trials rule 2019, able to coordinate with principal investigator and sponsor for startup activities…

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Job Post Details

Clinical Research Co-ordinator - job post

SUNACT CANCER INSTITUTE PRIVATE LIMITED
Thane, Maharashtra
₹25,570.09 - ₹31,374.66 a month

Job details

Pay

  • ₹25,570.09 - ₹31,374.66 a month

Job type

  • Full-time

Location

Thane, Maharashtra

Full job description

Key ResponsibilitiesStudy Coordination

  • Coordinate clinical trials and research projects from initiation to close-out.
  • Assist Principal Investigators (PIs) in study planning and execution.
  • Ensure adherence to approved study protocols and timelines.
  • Schedule and coordinate study visits, assessments, and follow-ups.

Participant Management

  • Screen, recruit, and enroll eligible study participants.
  • Conduct informed consent processes as per protocol and ethical guidelines.
  • Maintain regular communication with participants throughout the study.
  • Track participant compliance and retention.

Regulatory & Compliance

  • Maintain essential study documents and regulatory files.
  • Ensure compliance with ICH-GCP, CDSCO, NABH, and institutional requirements.
  • Prepare and submit documentation to Ethics Committees/IRBs.
  • Report protocol deviations, adverse events, and serious adverse events as required.

Data Management

  • Collect, verify, and maintain accurate study data.
  • Complete Case Report Forms (CRFs) and electronic data capture systems.
  • Ensure timely data entry and query resolution.
  • Maintain confidentiality and data integrity.

Sponsor & Site Coordination

  • Coordinate with sponsors, CROs, monitors, and study teams.
  • Support site initiation, monitoring, and audit visits.
  • Facilitate study-related training and meetings.

Documentation & Reporting

  • Maintain Trial Master Files (TMF) and Investigator Site Files (ISF).
  • Prepare study progress reports and recruitment updates.
  • Ensure all study records are audit-ready.

QualificationsEducation

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Nursing, or related healthcare field.

Experience

  • 1–5 years of experience as a Clinical Research Coordinator or Clinical Research Associate.
  • Experience in oncology clinical trials will be preferred.
  • Experience handling regulatory documentation and ethics committee submissions.

Required Skills

  • Knowledge of ICH-GCP guidelines and clinical trial regulations.
  • Strong documentation and organizational skills.
  • Proficiency in Microsoft Office and clinical trial databases.
  • Excellent communication and stakeholder management skills.
  • Ability to manage multiple studies simultaneously.
  • Attention to detail and compliance-focused approach.

Key Performance Indicators (KPIs)

  • Study enrollment and retention rates.
  • Protocol compliance and audit readiness.
  • Timely regulatory submissions.
  • Data quality and query resolution timelines.
  • Sponsor and investigator satisfaction.

Pay: ₹25,570.09 - ₹31,374.66 per month

Work Location: In person

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