- Performs 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 Practices (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 via review of site source documents and medical records
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 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 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 and may 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 direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned.
- May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.
- For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.Site Management Associate II. Additional responsibilities include:
- Site support throughout the study lifecycle from site identification through close-out
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection
- As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff
- The SMA II may be requested to train junior staff
- Identify and communicate out of scope activities to Lead 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
- Develop study and country level informed consent forms
- Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
- Participate in bid defense meetings
- Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy.
- Participate in Case Report Form design and edit check development.
- 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
- Oncology experience
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.
- Ability to manage required travel of up to 65% on a regular basis