Talent.com
CRA II (Sponsor dedicated)
CRA II (Sponsor dedicated)Syneos Health, Inc. • WorkFromHome, Waikato, New Zealand
CRA II (Sponsor dedicated)

CRA II (Sponsor dedicated)

Syneos Health, Inc. • WorkFromHome, Waikato, New Zealand
15 days ago
Job description

Updated : November 9, 2025

Location : NZL-Remote

Job ID : Why Syneos Health

Work Here Matters Everywhere

  • 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.

Job Responsibilities

  • Performs site qualification, site initiation, interim monitoring, site management activities 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. Maintains 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 / appropriate. Demonstrates diligence in protecting the confidentiality of each subject / patient. Assesses 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) : 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. 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 requirements.
  • May 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. Verifies issues or risks associated with blinded or randomized information related to IP. Applies 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 completeness. Reconciles contents of the ISF with the Trial 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 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 project objectives, 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 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. Participates in 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.
  • Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include : Site support throughout the study lifecycle from site identification through close‑out. Knowledge of local requirements for real world late phase study designs. Chart abstraction activities and data collection
  • Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out‑of‑scope activities to Lead CRA / Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.

    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 applicable regulatory requirements.
  • Must demonstrate good computer skills and be able to embrace new technologies.
  • Excellent communication, presentation and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
  • US ONLY : As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.
  • 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 the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health.

    Additional Information

    Tasks, 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.

    Summary

    Roles within Clinical Monitoring / CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk‑based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials.

    Contact

    Phone : Fax :

    Toll‑Free :

    Equal Opportunity Statement

    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 and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at : Email : One of our staff members will work with you to provide alternate means to submit your application.

    #J-18808-Ljbffr

    Create a job alert for this search

    Ii Sponsor Dedicated • WorkFromHome, Waikato, New Zealand

    Related jobs
    CRA II / SCRA (Auckland Home based)

    CRA II / SCRA (Auckland Home based)

    Syneos Health • WorkFromHome, Waikato, New Zealand
    CRA II (Auckland Home based) role at Syneos Health.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clin...Show more
    Last updated: 30+ days ago • Promoted
    Engineering Machine Learning Engineer New Zealand (Remote) FullTime

    Engineering Machine Learning Engineer New Zealand (Remote) FullTime

    Leonardo Interactive Pty • WorkFromHome, Waikato, New Zealand
    Ai is building one of the world’s most advanced generative-media platforms, empowering millions of people to turn ideas into high-quality images and videos in seconds. Now part of the Canva family, ...Show more
    Last updated: 5 days ago • Promoted
    Senior Software Engineer (AI)

    Senior Software Engineer (AI)

    Education Perfect • WorkFromHome, Waikato, New Zealand
    Education Perfect is an EdTech platform designed to empower educators and amplify their impact in the classroom.We aim to enable teachers to personalise learning at scale with a range of powerful l...Show more
    Last updated: 18 days ago • Promoted
    Senior Research Scientist - Generative AI

    Senior Research Scientist - Generative AI

    black.ai • WorkFromHome, Waikato, New Zealand
    Join the team redefining how the world experiences design.Hey, g'day, mabuhay, kia ora,你好, hallo, vítejte!.We know job hunting can be a little time consuming and you're probably keen to find out wh...Show more
    Last updated: 22 days ago • Promoted
    Computational Scientist NZ

    Computational Scientist NZ

    Berkeley Square IT • WorkFromHome, Waikato, New Zealand
    HPC Computational Scientist | Full-time | Remote | Nueva Zelanda.Eres un Científico Computacional experimentado, listo para llevar tu carrera al siguiente nivel? Nuestro cliente, una destacada empr...Show more
    Last updated: 5 days ago • Promoted
    Solution Advisor Specialist (Data Analytics & Artificial Intelligence)

    Solution Advisor Specialist (Data Analytics & Artificial Intelligence)

    SAP • WorkFromHome, Waikato, New Zealand
    At SAP, we keep it simple : you bring your best to us, and we'll bring out the best in you.We're builders touching over 20 industries and 80% of global commerce, and we need your unique talents to h...Show more
    Last updated: 27 days ago • Promoted
    Research Scientist - LLM Foundation Models

    Research Scientist - LLM Foundation Models

    Binance • WorkFromHome, Waikato, New Zealand
    Binance is a leading global blockchain ecosystem behind the world’s largest cryptocurrency exchange by trading volume and registered users. We are trusted by over 280 million people in 100+ countrie...Show more
    Last updated: 30+ days ago • Promoted
    Senior Software Engineer

    Senior Software Engineer

    Leonardo.Ai • WorkFromHome, Waikato, New Zealand
    Join the revolution at Leonardo.Ai, we’re on a mission to unleash the world’s creativity through cutting‑edge generative AI. We're an Australian startup building tools that reimagine how people desi...Show more
    Last updated: 29 days ago • Promoted
    Biology Expert

    Biology Expert

    DataAnnotation • WorkFromHome, Waikato, New Zealand
    We are looking for a Biology Expert to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of each m...Show more
    Last updated: 30+ days ago • Promoted
    Senior CRA

    Senior CRA

    ICON • WorkFromHome, Waikato, New Zealand
    Senior CRA, Home-based in Christchurch.ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and e...Show more
    Last updated: 13 days ago • Promoted
    Senior CRA

    Senior CRA

    ICON Strategic Solutions • WorkFromHome, Waikato, New Zealand
    Senior CRA, Home-based in Christchurch.ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and e...Show more
    Last updated: 9 days ago • Promoted
    Bioinformatics Researcher (PhD-Level)

    Bioinformatics Researcher (PhD-Level)

    Medcruit • WorkFromHome, Waikato, New Zealand
    Bioinformatics Researcher (PhD-Level).This range is provided by Medcruit.Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Mission : To revolutioni...Show more
    Last updated: 13 days ago • Promoted
    Epic Clinical Applications Lead - Remote / Hybrid

    Epic Clinical Applications Lead - Remote / Hybrid

    HealthTECH Resources Inc. • WorkFromHome, Waikato, New Zealand
    A healthcare consultancy firm is seeking an experienced Epic Clinical Applications Manager for a remote contract-to-hire or hybrid role. The position involves overseeing Epic environment management,...Show more
    Last updated: 2 days ago • Promoted
    Senior Software Engineer

    Senior Software Engineer

    Federato • WorkFromHome, Waikato, New Zealand
    Federato is on a mission to defend the right to efficient, equitable insurance for all.We enable insurers to provide affordable coverage to people and organizations facing the issues of today - the...Show more
    Last updated: 30+ days ago • Promoted
    Delivery Lead - HPV Screening (Remote, 12-Month)

    Delivery Lead - HPV Screening (Remote, 12-Month)

    Waikatodhbnewsroom • WorkFromHome, Waikato, New Zealand
    A leading health organization in New Zealand is seeking a Delivery Lead to manage and improve cervical screening processes. You'll provide strategic leadership, collaborate with internal and externa...Show more
    Last updated: 4 days ago • Promoted
    Senior Machine Learning Research Scientist - MLOps

    Senior Machine Learning Research Scientist - MLOps

    SmarterDx • WorkFromHome, Waikato, New Zealand
    Senior Machine Learning Research Scientist - MLOps.SmarterDx, a Smarter Technologies company, builds clinical AI that is transforming how hospitals translate care into payment.Founded by physicians...Show more
    Last updated: 22 days ago • Promoted
    Biologist | $110 / hr Remote | Mercor

    Biologist | $110 / hr Remote | Mercor

    Crossing Hurdles • WorkFromHome, Waikato, New Zealand
    Biologist | $110 / hr Remote | Mercor.Biologist | $110 / hr Remote | Mercor.Get AI‑powered advice on this job and more exclusive features. Part‑time (10–40 hours / week, with potential for increased hours...Show more
    Last updated: 1 day ago • Promoted
    Senior Data Scientist — Build Production‑Ready AI Solutions

    Senior Data Scientist — Build Production‑Ready AI Solutions

    Vero Insurance • WorkFromHome, Waikato, New Zealand
    A leading insurance provider is seeking a Senior Data Scientist to take a pivotal role in designing and delivering advanced AI projects. This technical position requires expertise in Python and mach...Show more
    Last updated: 2 days ago • Promoted