Opening for Sr CRA I

Job Description

*The Senior Clinical Research Associate I (SCRA I) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently. May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project or assessor of peers for sign-off visit purposes (as approved).JOB RESPONSIBILITIESPerforms site qualification, site initiation, interim monitoring, site management 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 processeso Conducts Source Document Review of appropriate site source documents and medical recordso Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical recordso Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelineso Utilizes available hardware and software to support the effective conduct of the clinical study data review and captureo Verifies site compliance with electronic data capture requirementsMay 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.Understands project scope, budgets, and timelines for own and others activities in the clinical team; 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 project 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, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:o Site support throughout the study lifecycle from site identification through close outo Knowledge of local requirements for real world late phase study designso Chart abstraction activities and data collectiono As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staffo The SMA II may be requested to train junior staffo Identify and communicate out of scope activities to Lead CRA/Project Managero Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associationso Identify operational efficiencies and process improvementso Develop country level informed consent formso Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and sharedoParticipate in bid defense meetings, *

• We need someone who must has more than 5 years onsite monitoring experience as a CRA (not industry or overall experience)
• We need someone in the North to cover the entire India region sites. Applicants must be located in NCR/Delhi/Gurgaon region.
• We need someone with degree in nursing or medicine. Degree in pharmacy can also be considered .
• We need someone with in-hospital experience as a nurse or medical doctor. In due of this, we can consider applicant with CRC experience.
• We need someone with in-hospital study monitoring experience.
• We need someone with Anti-Infective study monitoring experience
• Applicant can be home based / office based but should be from Delhi Region with good flight connectivity

Keyskills :
standard operating proceduresdata integrityelectronic data capturequery resolutionpatient advocacydocument reviewsite initiationinformed consentclinical datasite managementon sitestatements of work sow