CRA II/ Sr CRA I

As a CRA II/ Sr CRA I (Oncology) based in Mumbai for Syneos Health, your role is crucial in ensuring the integrity of clinical research studies by monitoring data and processes. Your responsibilities will include: - Having a minimum of 3-5 years of monitoring experience - Experience in therapeutic areas like Oncology, Hematology, Cardiology, Neuropsychiatry, Rare Disease, and Immunology - Candidate from Mumbai location with a Pharma background - Performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) compliance - Verifying the process of obtaining informed consent and protecting subject/patient confidentiality - Conducting Source Document Review, verifying clinical data accuracy, and resolving queries - Maintaining knowledge of ICH/GCP Guidelines, local regulations, and company SOPs/processes - Ensuring site compliance with electronic data capture requirements and IP inventory management - Reviewing the Investigator Site File for accuracy and completeness - Documenting activities via confirmation letters, follow-up letters, trip reports, and communication logs - Managing site-level activities and communication to ensure project objectives and timelines are met - Attending Investigator Meetings, sponsor meetings, and clinical training sessions - Providing guidance at the site and project level towards audit readiness standards - Maintaining knowledge of ICH/GCP Guidelines and relevant regulations - Completing assigned training as required Qualifications required for this role include: - Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements - Good computer skills and willingness to embrace new technologies - Excellent communication, presentation, and interpersonal skills - Ability to manage up to 75% travel on a regular basis Please note that this posting is intended for a possible upcoming opportunity. By expressing your interest, you will be added to the talent pipeline for consideration should this role become available. Syneos Health is committed to developing its people, offering career development, supportive management, training, recognition programs, and a total rewards program. The company values diversity and inclusivity to create a place where everyone feels they belong. For more information about Syneos Health, visit http://www.syneoshealth.com. Please be aware that tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign additional tasks or responsibilities at its discretion. Equivalent experience, skills, and education will also be considered. The Company retains the right to determine what constitutes as equivalent qualifications.,