The Clinical Research Associate II (CRA 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 / or all applicable local and federal regulatory requirements.
Performs all tasks routinely and independently, seeking guidance as needed.
Performs site qualification, site initiation, interimmonitoring, site management activities and close-out visits (performed on-siteor remotely) ensuring regulatory, ICH-GCP and / or Good PharmacoepidemiologyPractice (GPP) and protocol compliance.
immediatelycommunicates / escalates serious issues to the project team and develops actionplans. Maintains a working knowledge ofICH / GCP Guidelines or other applicable guidance, relevant regulations, andcompany SOPs / processes.
Verifies the process of obtaining informed consent has beenadequately performed and documented for each subject / patient, asrequired / appropriate.
Demonstrates diligence in protecting the confidentialityof each subject / patient. Assesses factors that might affect subject / patient’ssafety and clinical data integrity at an investigator / physician site such asprotocol deviation / violations and pharmacovigilance issues.
Per the Clinical Monitoring / Site Management Plan(CMP / SMP) :
Assesses site processes
Conducts Source Document Review of appropriate site sourcedocuments and medical records
Verifies required clinical data entered in the case reportform (CRF) is accurate and complete
Applies query resolution techniques remotely and on site,and provides guidance to site staff as necessary, driving query resolution toclosure within agreed timelines
Utilizes available hardware and software to support theeffective conduct of the clinical study data review and capture
Verifies site compliance with electronic data capturerequirements
May perform investigational product (IP) inventory,reconciliation and reviews storage and security. Verifies the IP has beendispensed and administered to subjects / patients according to the protocol.
Verifies issues or risks associated with blinded or randomized informationrelated to IP. Applies knowledge of GCP / local regulations and organizationalprocedures to ensure IP is appropriately (re)labelled, imported andreleased / returned.
Routinely reviews the Investigator Site File (ISF) foraccuracy, timeliness and completeness. Reconciles contents of the ISF with theTrial Master File (TMF).
Ensures the investigator / physician site is aware ofthe requirement of archiving essential documents in accordance with local guidelinesand regulations.
Documents activities via confirmation letters, follow-upletters, trip reports, communication logs, and other required project documentsas 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 assigned action items to resolution.
For assigned activities, understands project scope, budgets,and timelines; manages site-level activities / communication to ensure projectobjectives, 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 incollaboration with Central Monitoring Associate. Ensures all assigned sites andproject-specific site team members are trained and compliant with applicablerequirements.
Prepares for and attends Investigator Meetings and / or sponsorface to face meetings. Participates inglobal clinical monitoring / project staff meetings (inclusive of Sponsorrepresentation, as applicable) and attends clinical training sessions accordingto the project specific requirements.
Provides guidance at the site and project level towardsaudit readiness standards and supports preparation for audit and requiredfollow-up actions.
completesassigned training as required.
For Real World Late Phase, the CRA II will use the businesscard title of Site Management Associate II. Additional responsibilities include :
Site support throughout the study lifecycle from siteidentification through close-out
Knowledge of local requirements for real world late phasestudy designs
Chart abstraction activities and data collection
Collaboration with Sponsor affiliates, medical scienceliaisons and local country staff
The SMA II may be requested to train junior staff
Identify and communicate out of scope activities to LeadCRA / Project Manager
Proactively suggest potential sites based on local knowledgeof treatment patterns, patient advocacy and Health Care Provider (HCP)associations
Bachelor’s degree or RN in a related field or equivalentcombination of education, training and experience
2 years of clinical monitoring experience
Knowledge of Good Clinical Practice / ICH Guidelines andother applicable regulatory requirements
Must demonstrate good computer skills and be able toembrace new technologies
Excellent communication, presentation and interpersonalskills
Ability to manage required travel of up to 75% on aregular basis
Yes, 75 % of the Time