Job Description & Requirements
Job Description
- Protocol Review: Review and understand the study protocol, which outlines the objectives, design, methodology, and conduct of the clinical trial.
- Site Selection: Participate in the selection of appropriate clinical trial sites and investigators based on their qualifications and ability to conduct the study.
- Regulatory Compliance: Ensure that the clinical trial is conducted in compliance with relevant regulatory requirements, including Good Clinical Practice (GCP) guidelines. Assist in the preparation for and conduct of regulatory inspections.
- Site Initiation: Conduct site initiation visits to train investigators and site staff on the protocol, regulatory requirements, and data collection procedures.
- Monitoring: Regularly visit clinical trial sites to monitor the conduct of the study, including the verification of data accuracy, participant safety, and protocol adherence.
- Data Collection and Management: Oversee the collection, documentation, and verification of clinical trial data, ensuring that it is accurate, complete, and in compliance with the protocol.
- Safety Reporting: Monitor and report adverse events, protocol deviations, and other safety-related issues in accordance with regulatory requirements.
- Communication: Maintain regular communication with investigators, site staff, and study sponsors to address queries, provide guidance, and ensure the smooth progress of the trial.
- Documentation: Maintain and review essential documents, such as informed consent forms, ethics committee approvals, and other regulatory documents, to ensure compliance.
- Close-Out Visits: Conduct close-out visits to ensure that all required documentation is complete, and study materials are returned, and provide support for the finalization of the study report.
- Quality Assurance: Collaborate with quality assurance teams to ensure that the clinical trial processes adhere to quality standards and are audit-ready.
- Training: Provide training and support to site personnel on an ongoing basis to maintain protocol adherence and data integrity.
Job Requirements
- Education: A bachelor's degree in a relevant scientific or healthcare field. Degree in pharmacy, nursing, or MBBS preferred.
- Clinical Research Certification: Certified Clinical Research Professional (CCRP) or the Society of Clinical Research Associates (SoCRA) certification is a plus.
- Experience: Minimum 2 years of clinical monitoring experience in oncology trials.
- Knowledge of Regulations and Guidelines: A good understanding of Good Clinical Practice (GCP) guidelines, relevant regulatory requirements (such as FDA regulations), and other guidelines governing clinical research.
- Attention to Detail: Strong attention to detail to ensure accuracy in data collection and compliance with protocols.
- Communication Skills: Effective communication with study site personnel, investigators, and sponsors. Able to convey complex information clearly and professionally.
- Organizational Skills: Strong organizational skills to keep track of various aspects of the clinical trial.
- Problem-Solving Skills: The ability to identify and resolve issues or challenges that may arise during the course of a clinical.
- Teamwork: Ability to collaborate effectively with various stakeholders, including investigators, study coordinators, and sponsors.
- Ethical Conduct: Posses high ethical standards to ensure the safety and well-being of study participants and the integrity of the clinical trial data.
- Computer Skills: Proficiency in using various computer applications and clinical trial management systems.
- Travel Availability: Willingness and ability to travel to different clinical trial sites.
- Adaptability: Able to adapt to changes in study protocols, regulations, or project requirements.
