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Clinical Research Associate - Clinical Research Coordinator Experience

1-3 years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Remote 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

Job Title: Clinical Research Associate - Clinical Research Coordinator Experience

Location: Cincinnati, Ohio (Home-Based with Flexible Work Options)
Job ID: 10807
Job Type: Full-time


ABOUT MEDPACE

Medpace is a full-service clinical contract research organization (CRO), offering Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. Headquartered in Cincinnati, Ohio, we employ over 5,000 people in more than 40 countries.


JOB SUMMARY

Medpace is seeking Clinical Research Coordinators (CRCs) with at least 1 year of experience to transition into the role of a Clinical Research Associate (CRA). This exciting opportunity offers the chance to join our growing team with a comprehensive training program (PACE®), competitive salary, and flexible work-from-home options.


KEY RESPONSIBILITIES

Site Management & Monitoring

  • Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
  • Communicate effectively with site staff, including coordinators, clinical research physicians, and support staff.
  • Verify investigator qualifications and ensure resources are in place, including facilities, laboratories, and staff.

Documentation & Compliance

  • Review medical records and source documentation, ensuring alignment with case report form (CRF) data.
  • Address any entry errors and ensure adherence to good documentation practices (GDP), reporting protocol deviations in accordance with SOPs, GCP, and regulatory requirements.
  • Perform both on-site and virtual/remote monitoring using a risk-based approach to ensure compliance and mitigate risks.

Regulatory & Safety Monitoring

  • Verify eligibility of enrolled subjects and regulatory document review.
  • Monitor adverse events (AEs) and serious adverse events (SAEs), ensuring accurate data reporting in accordance with the protocol.
  • Ensure proper accountability of investigational products and medical devices.

Reporting & Recommendations

  • Complete monitoring reports and follow-up letters, summarizing key findings, deviations, deficiencies, and corrective actions.
  • Assess patient recruitment and retention strategies at clinical sites and provide recommendations for improvement.

QUALIFICATIONS & EXPERIENCE

Education:

  • Bachelor’s degree in a health or science-related field.

Experience:

  • Minimum 1 year of experience as a Clinical Research Coordinator (CRC).

Skills & Competencies:

  • Proficient in Microsoft Office and relevant software tools.
  • Strong communication and presentation skills.
  • Ability to travel 60-70% for site visits across the country.
  • Valid driver’s license and ability to travel to monitoring sites.
  • Detail-oriented, with excellent time management and organizational skills.

COMPENSATION & BENEFITS

Salary & Benefits:

  • Competitive salary with annual merit increases.
  • Equity/Stock Option Program and travel bonuses for high-performing CRAs.
  • 401K matching and comprehensive health, dental, and vision insurance.
  • Flexible work hours with the ability to work from home.

Career Development & Perks:

  • PACE® training program for career transition and development.
  • Leadership opportunities for career advancement (Lead CRA, CRA Manager, Clinical Trial Manager, etc.).
  • Home office furniture allowance, laptop, and mobile phone with hotspot for internet access.
  • Retain airline reward miles and hotel reward points.
  • In-house administrative support for CRAs at all levels.

AWARDS & RECOGNITION

  • Top Workplace in 2024 by The Cincinnati Enquirer.
  • Forbes: Recognized as one of America's Most Successful Midsize Companies (2021, 2022, 2023, and 2024).
  • CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.

WHY MEDPACE?

  • People, Purpose, Passion – Medpace is dedicated to making a positive impact in the world of clinical research.
  • The work we do today will improve the lives of patients across all major therapeutic areas and disease indications.

HOW TO APPLY

Join Medpace today and accelerate your career in clinical research. Apply now to become part of our growing team.