[Remote] Clinical Research Associate - Canada
Note: The job is a remote job and is reputed company to candidates in USA. reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. The Clinical Research Associate will reputed company site qualification, monitoring, and management to ensure compliance with regulatory standards and support the delivery of therapies.
Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management and reputed company-out reputed company (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology reputed company (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance 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/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of reputed company subject/patient. Assesses factors that might reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- Per the Clinical 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 clinical data entered in the case report reputed company (CRF) is accurate and complete reputed company review of site reputed company documents and medical records. Applies query reputed company techniques remotely 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 clinical 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 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 reputed company confirmation letters, follow-up letters, reputed company 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 reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company
- 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 reputed company to quickly adapt to changing priorities to reputed company goals / targets
- May reputed company as primary reputed company with project 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, and may, with supervision, reputed company, 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 reputed company training or mentorship to more junior level CRAs. May reputed company training and sign off reputed company for junior CRA staff, as assigned
- May be mentored and assigned clinical operations reputed company tasks under supervision of an reputed company Clinical Operations reputed company (COL), or operational line manager. For reputed company World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. 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 abstraction activities and data collection As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff Identify and communicate out of scope activities to reputed company CRA/Project Manager Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Identify operational efficiencies and process improvements reputed company country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is reputed company and shared Participate in bid defense meetings
Skills
- Bachelor's degree or RN in a reputed company field or equivalent combination of education, training and experience
- Knowledge of Good Clinical 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. Basic level of critical thinking skills expected
- Ability to manage required travel of up to 75% on a regular reputed company
Benefits
- Career development and progression
- Supportive and reputed company line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture – where you can authentically be yourself
- Ability to manage required travel of up to 75% on a regular reputed company
reputed company
Company H1B Sponsorship