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Cra Ii/ Sr Cra- Oncology Or Rare Disease (Located In Mi Or Il)

2+ years
$62,000 - $145,100
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

CRA II / Senior CRA - Oncology or Rare Disease (Located in MI or IL)
Updated: December 14, 2024
Location: United States-North America - USA-Michigan-Home-Based, United States
Job ID: 24006600-MI975

Job Description

Clinical Research Associate II

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success. By translating unique clinical, medical affairs, and commercial insights, we address the modern market needs.

Our clinical development model places the customer and the patient at the center of everything we do. We continuously strive to simplify and streamline processes, ensuring Syneos Health is easy to collaborate with and an even better place to work.

Whether you join us as part of a Functional Service Provider partnership or in a Full-Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to speed up the delivery of therapies because 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’re passionate about developing our people through career progression, training in technical and therapeutic areas, supportive management, peer recognition, and a total rewards program. Our Total Self culture promotes authenticity, uniting us globally and ensuring a positive workplace where everyone feels they belong.

Job Responsibilities

  • Site Qualification & Monitoring:
    Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely). Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol guidelines. Evaluate site performance, communicate issues to the project team, and develop action plans when needed.

  • Informed Consent & Patient Safety:
    Verify that informed consent has been appropriately obtained and documented for each subject. Assess risks related to protocol deviations, patient safety, and clinical data integrity at investigator sites.

  • Clinical Monitoring/Site Management:

    • Review and ensure the accuracy of clinical data in case report forms (CRFs) and verify compliance with electronic data capture.
    • Conduct source document review and apply query resolution techniques, driving resolution within timelines.
    • Review and monitor investigational product (IP) inventory, storage, and security according to protocol and regulations.
    • Ensure the accuracy and completeness of the Investigator Site File (ISF) and reconcile with the Trial Master File (TMF).
  • Recruitment & Retention:
    Support site recruitment, retention, and patient awareness strategies. Track observations and action items, ensuring timely resolution.

  • Audit & Compliance:
    Act as a primary liaison with site personnel, ensuring compliance with training and regulatory requirements. Prepare for audits and ensure audit readiness at the site level.

  • Late-Phase Studies (Real World):
    In late-phase studies, you will handle site support throughout the lifecycle, conduct chart abstraction, and collaborate with local and sponsor affiliates. May assist in training junior staff and suggest potential sites for study participation.

Qualifications

What We’re Looking For:

  • Education: Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
  • Experience: Knowledge of Good Clinical Practice (GCP) and ICH guidelines. Experience with clinical trials or site management in oncology or rare disease is preferred.
  • Skills: Strong communication, presentation, and interpersonal skills. Proficiency in computer software and new technologies.
  • Travel: Ability to manage travel requirements of up to 75% on a regular basis.

Get to Know Syneos Health

Over the past 5 years, Syneos Health has contributed to 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.

At Syneos Health, you'll challenge the status quo and thrive in an environment that is fast-paced and ever-evolving. Learn more about how we accelerate the delivery of life-changing therapies globally.

Additional Information

The tasks and responsibilities in this description are not exhaustive and may change at Syneos Health’s discretion. Equivalent experience, skills, and/or education will be considered. Syneos Health complies with all relevant federal, state, and municipal employment regulations, including those related to disability accommodations.

Compensation & Benefits

This position includes a company car or car allowance, health benefits (Medical, Dental, Vision), 401k company match, stock purchase plan eligibility, performance-based commissions/bonus, and flexible paid time off (PTO).

Annual Base Salary Range: $62,000 - $145,100, depending on experience and qualifications.

Syneos Health follows a voluntary COVID-19 vaccination policy and may require proof of vaccination for certain employees, based on local regulations.