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Clinical Research Coordinator Ii- Southaven, Ms

2+ years
$35-45 Per Hour
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

The Clinical Research Coordinator II position at Syneos Health involves managing, coordinating, and executing clinical trials to ensure compliance with protocols, regulations, and timelines. Below is a concise summary of the responsibilities and qualifications for this role:


Key Responsibilities

Clinical Research Preparation:

  • Review protocols and related documents (e.g., ICF, IB) for accuracy and feasibility.
  • Prepare and maintain Investigator Site Files (ISF) and Trial Master Files (TMF).
  • Lead start-up activities such as planning clinic logistics, creating source documents, and ensuring regulatory documentation is complete.

Study Coordination:

  • Recruit, screen, and consent potential study participants.
  • Manage clinic activities, including supervising visits, drug administration, and follow-up.
  • Ensure compliance with Good Clinical Practice (GCP) and protocol-specific guidelines.

Data and Documentation Management:

  • Collect and enter study data into appropriate systems within required timeframes.
  • Review Case Report Forms (CRFs) and monitor data accuracy.
  • Facilitate audits and respond to inquiries from sponsors or auditors.

Regulatory and Post-Study Activities:

  • Report adverse events (AEs/SAEs) and maintain study compliance documentation.
  • Finalize study-related documentation and address findings or deviations.
  • Oversee close-out activities, including archiving and returning study supplies.

Collaboration and Problem Solving:

  • Provide updates to project managers and sponsors.
  • Anticipate and address issues related to participant compliance, timelines, and project execution.
  • Participate in process improvement and SOP creation initiatives.

Qualifications

Education and Certification:

  • Registered Nurse (RN) or Bachelor's degree in a relevant field, such as Science.
  • Clinical Research certification preferred.

Experience:

  • Minimum 1 year of clinical research coordination experience (2+ years preferred).
  • Familiarity with ICH GCP guidelines, clinical trial EDC systems, and regulatory compliance.

Skills:

  • Strong problem-solving, planning, and multitasking abilities.
  • Excellent communication and interpersonal skills.
  • Proficiency with Microsoft Office Suite and clinical trial software.
  • Experience with SOP writing and maintaining study compliance.

Additional Requirements:

  • Ability to travel extensively (up to 100%).
  • Flexible availability for varied shifts (days, nights, weekends).

Compensation and Culture

  • Hourly salary: $35–$45/hour, based on qualifications and location.
  • Syneos Health promotes a supportive, inclusive Total Self culture, encouraging personal and professional growth.
  • Provides benefits supporting work-life balance and career progression.

This role offers the opportunity to contribute to impactful clinical trials, directly supporting advancements in healthcare while working in a dynamic and collaborative environment.