QED Pharmaceutical Services Hyderabad, Telangana
Urgently Required
Clinical Research Coordinators (CRCs)
Experience : 1 to 5 years
No of vacancies : 1
Job Description: Clinical Research Coordinators (CRCs) play a vital role in the conduct of clinical trials, acting as the linchpin between the trial’s operations and its success. They manage the day-to-day responsibilities of clinical studies, ensuring compliance with protocols, ethical guidelines, and regulatory requirements. CRCs coordinate activities to recruit participants, collect data, and maintain accurate records, working closely with investigators, participants, and other stakeholders.
Key Responsibilities: Study Coordination: Coordinate and manage clinical trial activities, ensuring all aspects of the study are conducted in accordance with the protocol, Good Clinical Practice (GCP), and regulatory requirements.
Participant Recruitment and Management: Assist in the recruitment of study participants, screen potential participants for eligibility, and manage participant activities throughout the trial, including consent, enrollment, and follow-up visits.
Data Collection and Management: Collect, record, and maintain research data and documentation with accuracy and integrity. Ensure timely data entry and resolve any discrepancies.
Compliance and Quality Control: Monitor study activities to ensure compliance with protocols and all applicable regulations. Conduct quality control checks to ensure data integrity and protocol adherence.
Communication: Serve as a primary point of contact for the research team, participants, and other stakeholders. Communicate study requirements effectively and provide updates on study progress.
Adverse Event Reporting: Monitor and report adverse events and protocol deviations in a timely manner to the investigator and relevant regulatory bodies.
Study Documentation: Maintain comprehensive records of study activities, including participant files, consent forms, and regulatory documents.
Logistics and Administration: Assist with study logistics, including scheduling appointments, preparing study materials, and organizing meetings.
Education Qualifications: Education: Bachelor’s degree in a life sciences or healthcare-related field. Relevant certifications, such as Certified Clinical Research Coordinator (CCRC), are advantageous.
Experience: Previous experience in clinical research or healthcare is preferred, demonstrating familiarity with clinical trials and regulatory requirements.
Skills: Excellent organizational, communication, and interpersonal skills; proficiency in data management and electronic data capture systems; attention to detail; ability to multitask.
Key Attributes: Detail-Oriented and Organized: Strong attention to detail and organizational skills to manage complex study requirements and maintain meticulous records.
Ethical and Responsible: A strong ethical foundation to ensure participant welfare and adherence to research ethics and patient confidentiality.
Adaptable and Proactive: Ability to adapt to changes in study protocols or regulations and proactively address potential issues in study execution.
Team Player with Strong Communication Skills: Effective communication skills to collaborate with the research team, participants, and other stakeholders, fostering a positive and productive working environment.
About the Role: Patient Advocate and Educator: Acts as an advocate for study participants, ensuring their rights are protected and they are fully informed about the study.
Data Steward: Manages and safeguards the integrity of clinical trial data, which is critical for the development of medical interventions.
Regulatory Liaison: Ensures that the study complies with regulatory requirements, serving as a point of liaison between the study and regulatory bodies.
Operational Specialist: Implements and manages the operational aspects of clinical trials, contributing to the advancement of medical research and patient care.
Clinical Research Coordinators are essential for the successful execution of clinical trials, ensuring they are conducted efficiently, ethically, and in compliance with all regulatory standards, thereby facilitating advancements in medical knowledge and treatment options.