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):
Assesses site processes
Conducts Source Document Review of appropriate site source documents and medical records
Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within 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 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.
Qualifications
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. Moderate level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis
