Research Regulatory Affairs Coordinator II

4 weeks ago

Spring Hills, Texas, United States Texas Oncology Full time

Overview:

Texas Oncology is seeking a highly skilled Research Regulatory Affairs Coordinator II to support our clinical trials team. This role will be based in The Woodlands, Texas location, which offers a great quality of life with highly rated public schools, urban living, shopping, dining, and recreational trails.

About the Role:

This position will be responsible for managing all regulatory processes and procedures for clinical trials, including preparing protocol documents, leading quality improvement measures, and ensuring site research quality. The ideal candidate will have a strong background in clinical research, regulatory affairs, and/or an oncology-related field, with excellent communication skills and the ability to multitask.

Responsibilities:

  • Coordinate critical document collection to facilitate the timely opening of trials at the site.
  • Communicate and collaborate with central operations to identify and resolve any regulatory issues.
  • Maintain protocol regulatory documents in compliance with local Standard Operating Procedures.
  • Review investigator files and verify all regulatory documents are filed in accordance with federal, state, and local regulations.
  • Assist with scheduling for monitoring visits, study start-up visits, close-out visits, and audits as needed.
  • Communicate issues with regulatory documents or procedures to clinical staff, research management, and investigators.
  • Assist with the preparation of informed consent documents and regulatory packets for sponsor and IRB submissions.
  • Process local and central Institutional Review Board submissions.
  • Coordinate local and central Institutional Review Board submissions.
  • Facilitate collection of site training documents from study initiation visits and coordinate and collect ongoing amendment training documents.
  • Coordinate the completion of feasibility surveys with appropriate staff, including PI, research management, and others as needed.

Qualifications:

  • High school diploma or equivalent required; some college coursework or other relevant background preferred.
  • Minimum three (3) years of experience in clinical research, regulatory affairs, and/or an oncology-related field required.
  • Experience in Microsoft Office.
  • Experience working with Sponsor Monitor representatives preferred.
  • Must have excellent communication skills, strong ability to multitask, and excellent time management skills.

Working Conditions:

  • Traditional outpatient clinic/office environment.
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements:

  • Large percent of time performing computer-based work is required.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

About Texas Oncology:

Texas Oncology is the largest community oncology provider in the country, with approximately 600+ providers in 280+ sites across Texas and southeastern Oklahoma. Our mission is to deliver high-quality, high-touch, evidence-based cancer care to help our patients achieve "More breakthroughs. More victories." in their fight against cancer.

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