The Senior Clinical Research Associate II (SCRA II)
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 all applicable local and federal regulatory requirements.Performs all tasks routinely and
independently.Mentors and/or trains, as
well as may assume line management responsibilities for less experienced
employees. May assume clinical functional leadership tasks as assigned, acting
as Lead CRA for a project.
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
·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
·Per the Clinical
Monitoring/Site Management Plan (CMP/SMP):
oAssesses site processes
oConducts Source Document Review of appropriate site source documents and
oVerifies required clinical data entered in the case report form (CRF) is
accurate and complete via review of site source documents and medical records
oApplies query resolution techniques remotely and on site, and provides
guidance to site staff as necessary, driving query resolution to closure within
oUtilizes available hardware and software to support the effective
conduct of the clinical study data review and capture
oVerifies site compliance with electronic data capture requirements.
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.
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
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 /
·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
·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
guidance at the site and project level towards audit readiness standards and
supports preparation for audit and required follow-up actions.
provide direct supervision, training and/or mentorship to more junior level
CRAs. Performs training and sign off visits for junior CRA staff, as assigned.
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.
Real World Late Phase (RWLP), the Sr. CRA II will use the business card title
of Sr.Site Management Associate II.Additional responsibilities include:
support throughout the study lifecycle from site identification through
of local requirements for real world late phase study designs
abstraction activities and data collection
required, collaborate and build relationship with Sponsor and other affiliates,
medical science liaisons and local country staff
II may be requested to train junior staff
and communicate out of scope activities to Lead CRA/Project Manager
suggest potential sites based on local knowledge of treatment patterns, patient
advocacy and Health Care Provider (HCP) associations.
operational efficiencies and process improvements
study and country level informed consent forms
with RWLP Regulatory team to ensure updated regulatory information is applied
in bid defense meetings
input into Requests for Proposals (RFPs), scope and budgeting.Develop site management strategy.
oParticipate 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
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
Tasks, duties, and responsibilities as listed in this job
description are not exhaustive. The Company, at its sole discretion and with no
prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so
qualifications of incumbents may differ from those listed in the Job
Description. The Company, at its sole discretion, will determine what
constitutes as equivalent to the qualifications described above. Further,
nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief
terms. Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it operates,
including the implementation of the EU Equality Directive, in relation to the
recruitment and employment of its employees.
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