Clinical Research Coordinator

5 hours ago

Pune, Maharashtra, India Med Bridge Full time ₹ 5,00,000 - ₹ 12,00,000 per year

Company Description

Med Bridge
Clinical Research Company is a leading organization dedicated to advancing healthcare through innovative clinical research. We collaborate with industry partners, healthcare professionals, and regulatory bodies to conduct high-quality clinical trials that contribute to the development of new therapies and medical advancements. Our mission is to ensure scientific integrity, patient safety, and excellence in every phase of research.

Key Responsibilities.

Study Coordination:

  • Coordinate the planning, initiation, execution, and closure of clinical trials.
  • Assist in the development and submission of study protocols, informed consent forms, and other regulatory documents.
  • Schedule and manage participant visits and ensure adherence to study timelines.

Participant Management:

  • Recruit, screen, and enroll eligible study participants.
  • Obtain informed consent and maintain confidentiality and ethical standards.
  • Monitor participant safety, collect data, and report adverse events according to protocol.

Data Management:

  • Maintain accurate and complete source documentation and case report forms (CRFs).
  • Ensure data integrity and compliance with Good Clinical Practice (GCP) guidelines.
  • Assist in data entry, query resolution, and database management.

Regulatory & Compliance:

  • Ensure study activities comply with Institutional Review Board (IRB)/Ethics Committee (EC) requirements.
  • Maintain regulatory binders, study logs, and essential documents.
  • Prepare for and participate in sponsor monitoring visits and regulatory audits.

Communication & Collaboration:

  • Act as a point of contact between investigators, sponsors, CROs, and study participants.
  • Participate in investigator meetings and study site training.
  • Provide updates and reports to the principal investigator and research team.

Qualifications

Education:

  • Bachelor's degree in health sciences, Bachelor's in Pharmacy , Diploma in Pharmacy, Masters in Life Science.
  • Opportunity for Experienced and Freshers can also apply.
  • Knowledge of ICH-GCP guidelines, FDA/EMA regulations, and IRB processes.

Skills:

  • Strong organizational and time management abilities.
  • Excellent communication and interpersonal skills.
  • Proficiency in electronic data capture (EDC) systems and MS Office Suite.
  • Attention to detail and ability to work independently and collaboratively.

Certifications (Preferred):

  • Advance Diploma in Clinical Research And Management.
  • Good Clinical Practice (GCP) certification.

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