CRA II/ Sr CRA- Central Region

1 month ago

Springfield, Illinois, United States Syneos Health - USA Full time


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.
    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. 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):
    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 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 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 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.

    • 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. Must 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 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, 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 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:
    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 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

    The salary band for this role is $80,600 to $145,000 annually.

    Qualifications

    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.

  • Commercial Loan Officer

    4 weeks ago

    Springfield, Illinois, United States Central Bancompany Full time

    POSITION SUMMARY:Solicits, develops and manages credit relations with individuals and businesses seeking a variety of secured and unsecured loans, including commercial, real estate, and construction. Oversees and manages commercial loan portfolio. Portfolio consists of the most complex commercial loan accounts; makes critical decisions independently....

  • Central Illinois

    3 weeks ago

    Springfield, Illinois, United States Enterprise Medical Recruiting Full time

    One of the largest, most advanced & financially successful hospital systems located in a beautiful riverfront community in Central Illinois, is looking to add an Endocrinologist. This top-level group serves a 300,000-population region and boasts exceptional physician satisfaction and a high retention rate.Practice Details Paying 300K+ base plus full...

  • Regional Contracts Administrator

    3 weeks ago

    Springfield, Illinois, United States Illinois Department of Human Services Full time

    This job was posted by : For more information, please see: Location: Springfield, IL, US, 62703 Job Requisition ID:[37253]{lang="en-US" careersite-propertyid="customfield2"} Agency: Department of Children and Family Services Closing Date/Time: 06/05/2024 Salary: Anticipated Starting Salary $7,660 - $9,167 Job Type:Salaried County: Sangamon Number of...

  • Hospitalist-East Central Illinois

    3 weeks ago

    Springfield, Illinois, United States Medicorp, Inc. dba Physician Empire Full time

    Hospitalist-East Central Illinois Employed practice seeks a BE/BC Internal Medicine or Family Medicine physician to join their team Competitive base salary offered with generous sign-on bonus Join a team of 60 hospitalists 7on/7off Closed ICU Dedicated Triage team Teaching opportunities if desired Physician can pick up more shifts Population of...

  • Regional Manager

    3 weeks ago

    Springfield, Illinois, United States WEXFORD HEALTH Full time

    To Apply for this Job Click HerePOSITION:Regional ManagerSCHEDULE:Full-Time / 8a-4p Weekends offFACILITY:CentralILLOCATION:Central, ILCurrently this region encompasses:Taylorville, Decatur, Danville, Logan and Graham A Job Should be MOREthan just a paycheck.Wexford Health Sources, Inc. is one of the nation's largest correctional health care providers. Over...

  • Sr. Finance Analyst

    4 weeks ago

    Springfield, Illinois, United States Expedia Group Full time

    If you need assistance during the recruiting process due to a disability, please reach out to our Recruiting Accommodations Team through the Accommodation Request form. This form is used only by individuals with disabilities who require assistance or adjustments in applying and interviewing for a job. This form is not for inquiring about a position or the...

  • Central Illinois Internal Medicine O/P

    1 month ago

    Springfield, Illinois, United States Enterprise Medical Recruiting Full time

    One of the largest, most advanced & financially successful hospital systems in a beautiful riverfrontcommunity in Central Illinois is looking to add two Primary Care physicians to join their longstanding practice.This top-level group serves a 300,000-population region and boasts exceptional physician satisfaction and a high retention rate. Practice...

  • Director, Regional Sales

    3 weeks ago

    Springfield, Illinois, United States Red Hat Full time

    About the jobThe Red Hat Sales team is looking for a Director of Sales for the Western U.S. region to join us in the Chicago Metropolitan area to lead our North Central pod. In this strategic role, you will manage and promote the success of a multi-product go to market strategy for Red Hat's Sales team. You'll report to the Enterprise Sales Leader for North...

  • Director, Regional Sales

    1 month ago

    Springfield, Illinois, United States Red Hat Full time

    About the jobThe Red Hat Sales team is looking for a Director of Sales for the Western U.S. region to join us in the Chicago Metropolitan area to lead our North Central pod. In this strategic role, you will manage and promote the success of a multi-product go to market strategy for Red Hat's Sales team. You'll report to the Enterprise Sales Leader for North...

  • Boiler Operator II

    4 weeks ago

    Springfield, Illinois, United States Missouri State University Full time

    Posting Details Position Information Position Title Boiler Operator II Work Location Springfield Campus Department Facilities Maintenance HR Home Department FAC MGMT-MAINTENANCE Pay Grade 26 Proposed Salary $22.61/hr. Position only available to current, regular, full-time Missouri State University employees? No, Position is available to all applicants....

  • Full Time Gastroenterology Physician

    1 month ago

    Springfield, Illinois, United States PeaceHealth Medical Group Full time

    DescriptionSeeking Gastroenterologist who enjoys bread & butter GI as well as advanced procedures to join our collegial group on the PeaceHealth Sacred Heart Medical Centers RiverBend campus.Join PeaceHealth's GI practice at RiverBendConsultative services only; no admits2 PA's supporting outpatient consultationFull GI surgical services availableERCP & EUS...

  • Sr Engagement Manager

    1 month ago

    Springfield, Illinois, United States Workday Full time

    Your work days are brighter here.At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that really set us apart was our culture. A culture which was driven by our value of putting our people...

  • Sr. Regulatory Compliance Engineer

    3 weeks ago

    Springfield, Illinois, United States ACCIONA S.A. Full time

    ACCIONA Energía is the biggest 100% renewable energy company with no fossil legacy in the world. With more than 30 years of experience and operations in 20 countries on five continents, ACCIONA Energía offers a wide portfolio of tailored energy solutions so that its corporate and institutional clients can meet their decarbonisation goals. This includes the...

  • Sr. Director, Ecommerce and Client Services

    3 weeks ago

    Springfield, Illinois, United States LVMH Full time

    Poste TAG Heuer: The Swiss Avant-Garde watchmaker since 1860. Avant-garde is our culture and philosophy. Our unique heritage is built on a disruptive mindset, an innovative approach and a cool, free-minded spirit to think ahead. TAG Heuer watches and chronographs are an authentic concentration of innovation, design and engineering for bold, confident people...

  • Sr. Claims Adj

    1 month ago

    Springfield, Illinois, United States Allianz Commercial Full time

    Let's care for tomorrow. Your ambitions. Your dreams. Your tomorrow At Allianz Commercial (AzC), we are the global leader for insuring corporate and specialty risks in the Allianz Group. Whether it's aircraft, satellites, the world's biggest ships and tallest building, cyber-attacks or climate change impacts, AzC has the major risks covered when it...

  • Emergency Medicine Opportunity in Illinois

    3 weeks ago

    Springfield, Illinois, United States Medicus Healthcare Solutions, LLC Full time

    Opportunity DetailsMedicus has an opportunity for an Emergency Medicine physician to provide locum coverage at a hospital in west-central Illinois.Opening Overview:Schedule: 7p-7aLevel II TraumaAnnual Volume: 28kProcedures: Standard intubation, central lines, joint reduction, sedation, laceration repairs, lumbar puncturesEMR: EpicMust be able to work...

  • Emergency Medicine Locum Tenens position in Springfield, Illinois

    1 month ago

    Springfield, Illinois, United States Medicus Healthcare Solutions Full time

    Opportunity DetailsMedicus has an opportunity for an Emergency Medicine physician to provide locum coverage at a hospital in west-central Illinois.Opening Overview: Schedule: 7p-7a Level II TraumaAnnual Volume: 28k Procedures: Standard intubation, central lines, joint reduction, sedation, laceration repairs, lumbar punctures*EMR: Epic Must be able to work...

  • Emergency Medicine Opportunity in Illinois

    1 month ago

    Springfield, Illinois, United States Medicus Healthcare Solutions, LLC Full time

    Opportunity DetailsMedicus has an opportunity for an Emergency Medicine physician to provide locum coverage at a hospital in west-central Illinois.Opening Overview:Schedule: 7p-7aLevel II TraumaAnnual Volume: 28kProcedures: Standard intubation, central lines, joint reduction, sedation, laceration repairs, lumbar puncturesEMR: EpicMust be able to work...

  • Hospitalist/Day and night

    1 month ago

    Springfield, Illinois, United States Enterprise Medical Recruiting Full time

    Our Hospitalist team in Western Illinois has recently transitioned to a hospital-employed group in order to offer the best possible package to physicians. About the Opportunity Located in West-Central IL 330-bed, Level II Trauma Center with excellent sub-specialty backup 7 on / 7 off Schedule Paid Time Off $300,000 annual compensation PLUS productivity...

  • Hospitalist Opening in Quincy, IL

    1 month ago

    Springfield, Illinois, United States Enterprise Medical Recruiting Full time

    A Hospitalist team in Western Illinois that has recently transitioned to a hospital-employed group in order to offer the best possible package to its physicians is searching for an additional hospitalist.About the Opportunity Located in West-Central Illinois 330-bed, Level II Trauma Center with excellent sub-specialty backup 7 on / 7 off Schedule, Paid...