Regulatory Affairs Coordinator

US Oncology Inc.; Denver (CO); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health, dental, and vision plans

Wellness program

Health savings account

Flexible spending accounts

401(k) retirement plan

Life insurance

Long-term disability insurance

PTO and holidays

Tuition reimbursement

Employee assistance program

Job summary

Rocky Mountain Cancer Centers in Denver, CO is seeking an experienced Regulatory Affairs Coordinator to oversee regulatory and administrative activities for clinical trials. The role requires ensuring compliance with SOPs, GCP, and regulatory guidelines across site activities.

You will collaborate with investigators and staff to manage regulatory documents, coordinate audits, and support submissions to IRBs and sponsors, while training teammates and improving QA processes.

Qualifications

• Associate's degree required; Bachelor's preferred in a clinical or scientific discipline.
• Minimum seven years of experience in clinical research or regulatory affairs.
• Experience with Phase 1-4 trials and regulatory documentation (IRB submissions).
• Experience working with Sponsor Monitor representatives and regulatory contacts.

Responsibilities

• Track protocol feasibility and coordinate critical document collection for trial openings.
• Maintain regulatory documents in compliance with SOPs.
• Coordinate audits and start-up/close-out visits.
• Communicate regulatory issues to staff and investigators.
• Prepare informed consent documents and regulatory packets for submissions.
• Facilitate IRB submissions and adverse event reporting.

Skills

Excellent communication skills

Multitasking

Time management

Interpersonal skills

Attention to detail

Adaptability to fast-paced environment

Education

Associate's degree

Bachelor's degree preferred

Tools

Microsoft Office

Job description

Overview

Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced Regulatory Affairs Coordinator in Denver.

We realize that it sounds cliché but it is true - taking care of cancer patients is a calling. It’s much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment.

No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient’s hand, or a scheduler on the phone finding an appointment that fits into a patient’s schedule, we are deeply connected to our patients and do what we can to help.

If this sounds like you, we’d love to have you join our team.

This position offers a hybrid work schedule, with a requirement to work onsite in the office two days per week. Candidates must reside within the Denver Metro area to support regular in-person collaboration and business needs.

Salary Range: $65,000-$95,000

Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements:

• Health, dental, and vision plans
• wellness program
• health savings account
• flexible spending accounts
• 401(k) retirement plan
• life insurance, short-term disability insurance
• long-term disability insurance, Employee Assistance Program
• PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance

Responsibilities

Under minimal supervision is responsible for the research regulatory and administrative activities of clinical trials for the practice. Plays an integral role in the regulatory/compliance process of all clinical research conducted to include site qualification, and management of the study regulatory documents throughout the site’s participation. Collaborates with research staff and management on process improvement and QA initiatives. May train other employees on regulatory process. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

Key Responsibilities

• In collaboration with investigators, responsible for tracking and completing protocol feasibility questionnaires. Coordinates Critical Document Collection to facilitate the timely opening of trials at the site. Communicates and collaborates with central operations and data management to identify and resolve any regulatory issues.
• Maintains Protocol Regulatory Documents in compliance with local and US Oncology Standard Operating Procedures.
• Coordinates scheduling and set up for audits and all Monitor, study start-up, and close out visits.
• Responsible for communication of any regulatory issues noted at visits to appropriate clinical staff, management or investigators.
• Prepares Informed Consent Documents and creates regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions.
• Coordinates local and central Institutional Review Board submissions. Reports SAEs to sponsor/FDA/IRB.
• Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.
• Actively participates in study initiations and study specific educational programs.
• Compiles and monitors information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials. Acting as a subject matter expert may orient/train other staff in regulatory process.
• Collaborates with research staff and management on process improvement and QA initiative.

Qualifications

Associate's degree required. Bachelor's degree in a clinical or scientific related discipline preferred.

Minimum seven years of experience in clinical research, regulatory affairs and/or an oncology related field required.

Ideally, we want someone with 5-7 years of clinical research experience which would mean any research related to human research.

We are looking for candidates who have experience with Phase 1-4 clinical trials. Ideally, someone who has experience with the regulatory aspects of research documentation such as regulatory and IRB submissions.

Business Experience

• Experience in Microsoft Office
• Experience working with Sponsor Monitor representatives.

Specialized Knowledge/Skills

• Experience working in clinical research is preferred
• Must have excellent communication skills
• Strong ability to multi-task
• Excellent time management skills
• Must have strong interpersonal skills to be able to interact with multiple people on many different levels.
• Must have a high level of attention to detail
• Must be able to work in a fast-paced environment.

All qualified candidates are required to pass a background check prior and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire.

Working Conditions

Working Conditions: 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. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.

Physical Requirements

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. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)