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Clinical Research Coordinator Lead/Manager - 248029
Clinical Research Coordinator Lead/Manager - 248029Medix • New Orleans, LA, United States
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Clinical Research Coordinator Lead / Manager - 248029

Clinical Research Coordinator Lead / Manager - 248029

Medix • New Orleans, LA, United States
10 days ago
Job type
  • Full-time
Job description

Job Title : Lead Clinical Research Coordinator (CRC)

Location : New Orleans, LA

Schedule : Monday–Friday, 9 : 00 AM–5 : 00 PM (On-site)

Type : Contract-to-Hire, 6 month

Pay : $32-$40 / hour

Overview

We are seeking an experienced and driven Lead Clinical Research Coordinator to help build and lead a brand-new research department from the ground up. This individual will serve as both a hands-on coordinator and a leader, managing all aspects of clinical trials while guiding a new physician and eventually mentoring a team of CRCs. This is a unique opportunity for someone eager to take ownership, grow into a management role, and be the backbone of a developing clinical research program.

Key Responsibilities

  • Serve as the primary point of contact for all clinical research activities at the site.
  • Perform end-to-end study coordination, from startup and recruitment through closeout.
  • Prepare and manage study documentation, including regulatory binders, source documents, and eSource / CTMS data entry.
  • Conduct participant visits, including consent, assessments, and procedures such as phlebotomy and EKGs as needed.
  • Oversee participant recruitment using EMR systems and community outreach initiatives.
  • Ensure all studies are conducted in compliance with FDA, ICH-GCP, and sponsor requirements.
  • Maintain meticulous documentation and quality control across all studies to ensure audit readiness.
  • Collaborate with and train a new physician principal investigator (PI), providing guidance on research processes and best practices.
  • Lead and mentor future CRC hires, delegating tasks, conducting quality reviews, and maintaining workflow balance.
  • Manage investigational product accountability and study supply inventory.
  • Prepare for and participate in sponsor, CRO, and FDA monitoring visits or audits.
  • Over time, assume expanded responsibilities such as budget negotiations and contract management.

Typical Day Breakdown

  • Morning : Prepare for participant visits, review eSource systems, greet and consent participants, and perform study procedures.
  • Midday : Manage regulatory files, recruitment activities, and communication with the PI and site staff.
  • Afternoon : Conduct quality control reviews, mentor newer staff, and meet with sponsors or prepare for audits.
  • End of Day : Log activities in CTMS, organize documentation, and plan for upcoming study visits.
  • Qualifications (Must-Have)

  • Minimum of 3 years of experience as a Lead Clinical Research Coordinator .
  • Proven ability to manage complex protocols independently from startup to closeout.
  • Strong regulatory knowledge, including IRB submissions, essential documents, and FDA / ICH-GCP compliance.
  • Fully comfortable in an on-site role (Monday–Friday).
  • Exceptional organizational skills and attention to detail.
  • Preferred Skills (Nice-to-Haves)

  • Phlebotomy and EKG experience.
  • Prior experience supporting sponsor or FDA audits.
  • Experience training or working with research-naïve PIs.
  • Why This Role Is Exciting

  • Opportunity to lead and build a new clinical research program from the ground up.
  • Direct mentorship from a physician PI who values work-life balance and flexibility.
  • Clear career growth trajectory into a Research Manager role with team-building responsibility.
  • Supportive and human-centered work environment—understanding that life happens.
  • This role is ideal for an experienced CRC who thrives in dynamic settings, loves taking initiative, and wants to grow into leadership.

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    Clinical Research Coordinator • New Orleans, LA, United States

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