As a Site Monitor, your primary responsibility will be to ensure the smooth and compliant execution of clinical trials conducted at various research sites. You will work closely with the clinical research team and investigators to monitor the progress and quality of clinical studies, ensuring adherence to protocols, regulations, and good clinical practices. This role requires strong attention to detail, excellent communication skills, and the ability to work independently.

Key Responsibilities:

Site Selection and Initiation:

• Participate in the selection and evaluation of potential research sites based on their capabilities, experience, and resources.
• Conduct site initiation visits to provide training on study protocols, procedures, and regulatory requirements to investigators and site staff.

Study Monitoring:

• Perform regular on-site visits to monitor ongoing clinical trials, ensuring compliance with study protocols, applicable regulations, and ethical guidelines.
• Review and verify the accuracy and completeness of study documents, including informed consent forms, case report forms, and source documents.
• Monitor subject enrollment, eligibility criteria, and informed consent processes to ensure the integrity of the study data.
• Verify that investigational products are appropriately handled, stored, and accounted for at the research sites.
• Monitor and document adverse events, protocol deviations, and other study-related issues, ensuring timely reporting to the sponsor and relevant authorities.

Data Management:

• Verify the accuracy and completeness of data recorded in case report forms (CRFs) by comparing them to source documents.
• Ensure data confidentiality and maintain data integrity throughout the study by implementing appropriate quality control measures.
• Assist sites in resolving data queries and discrepancies, providing guidance on data collection and reporting.

Compliance and Regulatory Oversight:

• Ensure compliance with applicable regulatory requirements, including Good Clinical Practice (GCP) guidelines, International Conference on Harmonisation (ICH) guidelines, and local regulations.
• Review and assess site adherence to study protocols, standard operating procedures (SOPs), and relevant regulations.
• Assist in the preparation of study-specific documents, such as monitoring plans, study manuals, and standard operating procedures.

Communication and Collaboration:

• Maintain effective communication with investigators, site personnel, study coordinators, and sponsor representatives to address study-related issues and provide guidance.
• Prepare comprehensive monitoring reports documenting site visits, findings, and recommendations.
• Collaborate with cross-functional teams, including data management, biostatistics, and medical affairs, to ensure study objectives are met.

Qualifications and Skills:

• Bachelor's degree in life sciences paramedical or a related field. A higher degree (e.g., Master's) is preferred.
• Previous experience as a clinical research associate or site monitor is highly desirable.
• Sound knowledge of clinical research regulations, GCP guidelines, and ICH guidelines.
• Familiarity with electronic data capture systems and clinical trial management systems.
• Excellent organizational skills and attention to detail.
• Strong verbal and written communication skills.
• Ability to travel frequently and independently to research sites as required.
• Proficiency in MS Office applications (Word, Excel, PowerPoint) and data analysis tools.

Patanjali Research Foundation is an equal opportunity employer and does not discriminate against any applicant because of race, colour, religion, gender, national origin, age and physical disability.

How to Apply

• Write to jobs@patanjali.res.in with your detailed CV and career aspirations.
• Mention Site Monitor for Clinical Research, citing respective Job Code.
• List three professional references other than your friends and family.