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    Clin Research Coordinator Ii- San Antonio, Tx

    Syneos Health
    2+ years
    $57-$67 per hour
    Remote, USA
    10 Dec. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Clinical Research Coordinator II - San Antonio, TX
    Updated: December 19, 2024
    Location: United States-North America - USA-Texas-Home-Based, United States
    Job ID: 24006973

    Job Description

    Clinical Research Coordinator II

    Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to deliver impactful outcomes in response to modern market needs.

    At Syneos Health, we place the customer and the patient at the core of our operations. We continuously seek ways to simplify and streamline our work, making Syneos Health easier to collaborate with and a great place to work.

    Whether you’re part of a Functional Service Provider partnership or a Full-Service environment, you will work alongside passionate problem solvers, innovating as a team to help our customers achieve their goals. Driven to accelerate the delivery of therapies, we are passionate about changing lives.

    Discover what our 29,000 employees, across 110 countries, already know:
    WORK HERE MATTERS EVERYWHERE

    Why Syneos Health

    We are committed to developing our people through career progression, ongoing training, and a supportive line management system. Our Total Self culture is what unites us globally, encouraging individuals to authentically be themselves. We foster a diverse environment, where different perspectives thrive, creating a workplace where everyone belongs.

    Job Responsibilities

    Clinical Research Project Planning and Preparation

    • Review assigned protocols and related documents (ICF, IB) for accuracy, feasibility, and resource requirements.
    • Prepare and maintain the Investigator Site File (ISF) or Trial Master File (TMF) for the study.
    • Assist in the creation and review of timelines, and facilitate start-up meetings (e.g., Investigator Meeting/SIV).
    • Coordinate start-up activities such as clinic logistics, schedule planning, team training, and the preparation of study materials (e.g., source documents, time and events tables).
    • Collaborate with responsible teams to establish safety assessment requirements, quality control (QC) and monitoring plans, and ensure necessary supplies and equipment are available.

    Clinical Conduct

    • Perform study activities in accordance with Good Clinical Practice (GCP).
    • Manage multiple clinical trials simultaneously and ensure the safety of participants.
    • Support participant recruitment, screening, and informed consent.
    • Collect and enter study data within the required timeframe, and complete Case Report Forms (CRFs).
    • Monitor and track Adverse Events (AEs) or Serious Adverse Events (SAEs) and report findings as needed.
    • Supervise clinic activities, including patient screening, drug administration, and follow-up procedures.
    • Ensure study-related activities are conducted per protocol, Standard Operating Procedures (SOPs), and regulatory guidelines.

    Post-Clinic and Close-Out Activities

    • Coordinate the resolution of any issues related to QC, CRF completion, and study documentation.
    • Oversee close-out activities including review and finalization of study reports, deviation reporting, and TMF documentation.
    • Monitor subject compliance and address any issues promptly, escalating when necessary.
    • Participate in sponsor/monitor/QA audits and provide accurate project status updates.

    Regulatory Activities

    • Maintain and submit protocol amendments, consents, and yearly renewals as required.
    • Report adverse events and maintain updated study files.
    • Travel up to 100% as needed for clinical activities.

    Qualifications

    What We’re Looking For:

    • Required: Registered Nurse or a University Degree (e.g., Bachelor of Science) in a relevant field.
    • Preferred: Clinical Research Certification.
    • A minimum of 1 year of experience in clinical research, with preference given to those with 2+ years in clinical research coordination.
    • Solid understanding of regulations, ICH GCP, privacy laws, and clinical research guidelines.
    • Strong problem-solving, time management, and multitasking abilities.
    • Excellent interpersonal and communication skills with a team-focused attitude.
    • Proficiency in Microsoft Office (Word, Excel, PowerPoint) and clinical trial software.
    • Knowledge of SOP writing and the ability to anticipate and address issues proactively.

    Get to Know Syneos Health

    Over the last five years, Syneos Health has contributed to the success of 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and supported over 200 studies across 73,000 sites with 675,000+ trial patients.

    No matter your role, you'll take initiative and challenge the status quo in a fast-paced and ever-changing environment. Learn more about how Syneos Health accelerates the delivery of life-changing therapies globally.

    Additional Information

    The duties and responsibilities outlined in this job description are not exhaustive. The company may assign additional responsibilities as needed, based on business requirements. Equivalent experience, skills, and/or education will be considered. This description complies with the relevant legislation and includes provisions for reasonable accommodations where appropriate.

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