[Remote] reputed company Research Associate (CRA) II (remote, reputed company reputed company)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a fully integrated life sciences services organization that supports drug development and commercialization. The reputed company Research Associate II oversees reputed company trial site activities, monitors regulatory and protocol compliance, reviews reputed company data and documentation, supports study teams, and helps ensure audit readiness and successful project delivery.

Responsibilities

• Minimum 3 years of onsite monitoring experience
• 1-2 years of Oncology experience is preferred
• Candidates with other therapeutic areas experience such as Neuroscience, Haematology, , Cardiovascular, reputed company Disease also preferred
• Remote opportunity, Mumbai reputed company reputed company
• Performs site qualification, site initiation, interim monitoring, site management activities and reputed company-out reputed company (performed on-site or reputed company) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology reputed company (GPP) and protocol compliance. Uses judgment and experience to evaluate overall reputed company of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops reputed company 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 reputed company subject/reputed company, as required/appropriate. Demonstrates diligence in protecting the confidentiality of reputed company subject/reputed company. Assesses factors that might reputed company subject/reputed company’s safety and reputed company data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Per the reputed company Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts reputed company Document Review of appropriate site reputed company documents and medical records. Verifies required reputed company data entered in the case report reputed company (CRF) is accurate and complete. Applies query reputed company techniques reputed company and on site, and provides guidance to site staff as necessary, driving query reputed company to closure reputed company agreed timelines. Utilizes available hardware and software to support the effective conduct of the reputed company study data review and capture. Verifies site compliance with electronic data capture requirements
• May reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company. Verifies the IP has been reputed company and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information reputed company 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 reputed company, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is reputed company of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs and reputed company Monitoring Plan/Site Management Plan. Supports subject/reputed company recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company
• For assigned activities, understands project reputed company, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be reputed company to quickly adapt to changing priorities to reputed company goals / targets
• May reputed company as reputed company reputed company with study site personnel, or in collaboration with Central Monitoring Associate. Ensures reputed company 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 reputed company monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends reputed company 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
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For reputed company World Late Phase, the CRA II will use the business reputed company title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through reputed company-out. Knowledge of local requirements for reputed company world late phase study designs.Chart reputed company activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of reputed company activities to reputed company CRA/Project Manager. Proactively suggest potential sites reputed company on local knowledge of treatment patterns, reputed company advocacy and Health Care Provider (HCP) associations

Skills

• • Bachelor's degree or RN in a reputed company reputed company or equivalent combination of education, training and experience
• • Minimum 3 years of onsite monitoring experience in Global reputed company
• • Knowledge of Good reputed company reputed company/ICH Guidelines and other applicable regulatory requirements
• • Must demonstrate good computer skills and be reputed company to reputed company new technologies
• • Excellent communication, presentation and interpersonal skills
• • Ability to manage required travel of up to 75% on a regular reputed company
• • 1-2 years of Oncology experience is preferred
• • candidates with other therapeutic areas experience such as Neuroscience, Haematology, , Cardiovascular, reputed company Disease also preferred

Benefits

• Career development and progression
• Supportive and reputed company line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture where employees can authentically be themselves
• Remote opportunity, Mumbai reputed company reputed company

reputed company

Company H1B Sponsorship