CRA II or SR CRA (Home base, Sponsor Dedicated)Updated:December 24, 2024
Location:Malaysia-Asia Pacific - MYS-Home-Based
Job ID: 24007092
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Job Summary:
The Senior Clinical Research Associate I (SCRA I) 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.
May 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 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.
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.
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 requirementsMay 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.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Reconciles contents of the ISF with the Trial Master File (TMF).
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.
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.
May act as primary liaison with project 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.
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 CRAs.
Qualifications
What we're looking for
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
CRA II: 2 years of monitoring experience
SR CRA: 4 years of monitoring 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.
Basic level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace.
If your past experience doesn't align perfectly, we encourage you to apply anyway.
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