Senior CRA I/II

Senior CRA I/II (Melbourne, Sydney, Brisbane) Updated: YesterdayLocation: AUS-RemoteJob ID: Description Senior CRA I/II (Melbourne, Sydney, Brisbane) 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 EVERYWHERE Why Syneos Health We 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. Responsibilities Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate site performance and provide recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains knowledge of ICH/GCP Guidelines, applicable guidance, regulations, and company SOPs/processes. Verifies informed consent processes are adequately performed and documented; protects confidentiality; assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations, pharmacovigilance issues). Per CMP/SMP: assesses site processes. Conducts Source Document Review of site source documents and medical records. Verifies data entered in CRFs is accurate via review of source documents. Applies query resolution remotely and on-site; guides site staff to drive query resolution to closure within timelines. Utilizes hardware/software to support data review and capture. Verifies site compliance with electronic data capture requirements. May perform IP inventory, reconciliation and reviews storage and security. Verifies IP is dispensed and administered per protocol. Assesses IP-related risks related to blinded or randomized information. Ensures IP labelling, import and release/return per GCP/local regulations and procedures. Routinely reviews the Investigator Site File (ISF) for accuracy; reconciles with the Trial Master File (TMF). Ensures site is aware of archiving requirements per local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, logs, and other required documents per SOPs and CMP/SMP. Supports subject recruitment, retention and awareness strategies. Enters data into tracking systems to monitor observations and action items. Understands project scope, budgets, and timelines; manages site-level activities to meet project objectives and timelines. Adapts to changing priorities to achieve goals/targets. Acts as primary liaison with project site personnel or with Central Monitoring Associate. Ensures all assigned sites and team members are trained and compliant with requirements. Prepares for and attends Investigator Meetings and sponsor meetings. Participates in and may lead global clinical monitoring/project staff meetings and attends clinical training sessions as required. Provides guidance towards audit readiness and supports preparation for audits and follow-up actions. May provide training or mentorship to more junior CRAs. May 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 Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include: site support throughout the study lifecycle; knowledge of local requirements for RWLP; chart abstraction and data collection; collaboration with Sponsor and affiliates; identification of out-of-scope activities; proposing sites; identifying efficiencies and process improvements; developing country-level informed consent forms; collaborating with RWLP Regulatory team; participating in bid defense meetings. Qualifications 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 regulatory requirements Must have good computer skills and adaptability to new technologies Excellent communication, presentation and interpersonal skills; basic critical thinking Ability to travel up to 75% on a regular basis Get to know Syneos Health Over 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 initiative and challenge the status quo in a highly competitive environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes equivalent qualifications. Nothing herein should be construed as a contract. Language is to comply with local obligations, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations to assist applicants. Summary Roles within Clinical Monitoring/CRA involve monitoring during clinical trials to ensure compliance with practices. This includes on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. The role may involve managing two or fewer employees and may involve directing work or processes. The work focuses on design, implementation or delivery of processes, programs, and policies. At Syneos Health, we are committed to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage joining our Talent Network for future opportunities. Discover what our 29,000 employees know: work here matters everywhere. We work hard and smart to bring therapies to patients. Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at for alternate submission options. #J-18808-Ljbffr