Fsp- Sr Crai/ Ii

Join to apply for the FSP- Sr CRAI/ II (Melbourne/ Sydney) role at Syneos Health2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.DescriptionFSP- Sr CRAI/ II (Melbourne/ Sydney)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.Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself.
Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with.
Why?
Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.ResponsibilitiesConduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, case report forms, and regulatory documentsDevelop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating proceduresContribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stagesDirect the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activitiesEnsure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that ariseProvide guidance and support to clinical research teams, including answering questions, resolving issues, and facilitating communication between team members and stakeholdersMaintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databasesIdentify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and preventive actions as neededCollaborate with cross-functional teams to ensure successful trial execution, including working with project managers, data managers, biostatisticians, and regulatory affairs specialistsQualificationsBachelor's degree in a related fieldMinimum of 5 years of experience in clinical research monitoring; this role is a progression within the level from a Sr CRA IIn-depth knowledge of clinical trial processes and regulationsStrong analytical and problem-solving skillsExcellent communication and interpersonal skillsAbility to work independently and as part of a teamCertificationsCertified Clinical Research Associate (CCRA) or equivalent certification preferredNecessary SkillsProficiency in clinical trial management systems and softwareAbility to manage multiple projects and prioritiesStrong attention to detail and organizational skillsAbility to travel as required for on-site monitoringKnowledge of Good Clinical Practice (GCP) guidelines and regulatory requirementsGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Learn more about Syneos Health. InformationTasks, 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.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.SummaryRoles within Clinical Monitoring/CRA job family at the P22 level are responsible for monitoring clinical research studies to ensure that trials are conducted in accordance with widely accepted clinical practices.
This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring.
These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, who may manage two or fewer employees and direct the work of lower-level professionals or manage processes and programs.
The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.
Impact and Contribution Roles within Clinical Monitoring/CRA job family at the P22 level have a significant impact on the success of clinical research studies.
They ensure that clinical projects are conducted, recorded, and reported in accordance with protocols, company and sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements.
These roles contribute to the overall quality and integrity of clinical data, protect the confidentiality of subjects/patients, and assess factors that might affect subject/patient safety and clinical data integrity.
They also provide recommendations regarding site-specific actions, communicate serious issues to the project team, and develop action plans.
Additionally, these roles may assume clinical functional leadership tasks, act as primary liaison with study site personnel, and provide guidance at the site and project level towards audit readiness standards.Core FocusEnsure regulatory, ICH-GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close-out visitsEvaluate overall performance of site and site staff, provide recommendations regarding site-specific actions, and communicate serious issues to the project teamVerify the process of obtaining informed consent, protect the confidentiality of subjects/patients, and assess factors affecting subject/patient safety and clinical data integrityConduct Source Document Review, verify clinical data accuracy and completeness, and apply query resolution techniquesVerify site compliance with electronic data capture requirements and investigational product (IP) inventory, reconciliation, storage, and securityReview Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile contents with the Trial Master File (TMF)Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documentsManage site-level activities and communication to ensure project objectives, deliverables, and timelines are metAct as primary liaison with study site personnel, ensure training and compliance with applicable requirements, and provide guidance towards audit readiness standardsProvide direct supervision, training, and mentorship to junior level CRAsSeniority levelMid-Senior levelEmployment typeFull-timeJob functionOtherGet to know Syneos HealthAdelaide, South Australia, Australia 6 days ago
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