Job responsibilities
•    Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.  Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.  Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
•    Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

•    Per the Clinical Monitoring/Site Management Plan (CMP/SMP):  
o    Assesses site processes
o    Conducts Source Document Review of appropriate site source documents and medical records
o    Verifies required clinical data entered in the case report form (CRF) is accurate and complete 
o    Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines 
o    Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture 
o    Verifies site compliance with electronic data capture requirements

•    May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. 
•    Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.  
•    Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.  Supports subject/patient recruitment, retention and awareness strategies.  Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
•    For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.  Must be able to quickly adapt to changing priorities to achieve goals / targets.  
•    May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.  Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
•    Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.  Participates in global clinical monitoring/project staff me

Experience:

• Minimum 3yrs of experience in onsite monitoring and remote monitoring.
• Should have Neurology, immunology, rare diseases, CVD and Oncology therapeutic area experience preferred.
• Candidate from Mumbai, Delhi, Bengaluru, Hyderabad, Ahmedabad preferred.
• 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 applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
•  Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Apply: https://www.syneoshealth.com/careers/jobs/15190744-cra-ii