Job details
Job type full-time number of hires for this role on-going need to fill this role
Full job description
The clinical research associate 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 requirementsPerforms all tasks routinely and independentlyMay assume clinical functional leadership tasks as assigned, acting as lead cra for a project or assessor of peers for sign-off visit purposes (as approved).
Job responsibilities
· 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 practice (gpp) and protocol complianceUses 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 plansMaintains 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/appropriateDemonstrates diligence in protecting the confidentiality of each subject/patientAssesses 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 securityVerifies the ip has been dispensed and administered to subjects/patients according to the protocolVerifies issues or risks associated with blinded or randomized information related to ipApplies 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 completenessReconciles 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 planSupports subject/patient recruitment, retention and awareness strategiesEnters data into tracking systems as required to track all observations, ongoing status and assigned 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 metMust be able to quickly adapt to changing priorities to achieve goals / targets.
· may act as primary liaison with project site personnel, or in collaboration with central monitoring associateEnsures 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 meetingsParticipates, and may, with supervision, 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 training or mentorship to more junior level crasMay perform training and sign off visits for junior cra staff, as assigned.
· may be mentored and assigned clinical operations lead tasks under supervision of an experienced clinical operations lead (col), or operational line manager.
· for real world late phase (rwlp), the srCra i will use the business card title of srSite management associate iAdditional responsibilities include:
O site support throughout the study lifecycle from site identification through close out
O knowledge of local requirements for real world late phase study designs
O chart abstraction activities and data collection
O as required, collaborate and build relationships with sponsor and other affiliates, medical science liaisons and local country staff
O the sma ii may be requested to train junior staff
O identify and communicate out of scope activities to lead cra/project manager
O proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and health care provider (hcp) associations
O identify operational efficiencies and process improvements
O develop country level informed consent forms
O collaborate with rwlp regulatory team to ensure updated regulatory information is applied and shared
O participate in bid defense meetings
Qualification requirements
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 skillsBasic level of critical thinking skills expected.
Ability to manage required travel of up to 50% on a regular basis
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustiveThe company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilitiesEquivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the job descriptionThe company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described aboveFurther, nothing contained herein should be construed to create an employment contractOccasionally, required skills/experiences for jobs are expressed in brief termsAny 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.
Job clinical monitoring
Schedule full-time
Travel yes, 50 % of the time
Employee status regular
Job type: full-time
Schedule:
8 hour shift
Work remotely:
Yes
