Research Regulatory Coordinator

Highlands Oncology Group; Springdale (AR); In loco; USD 52.000 - 75.000; Tempo pieno

Descrizione del lavoro

Highlands Oncology Group is seeking a Research Regulatory Coordinator to ensure regulatory documentation and compliance for clinical trials, aligning with GCP, Highlands policies, and sponsor requirements. The role supports the coordination of regulatory binders, IRB submissions, and sponsor communications.

You will interact with PI, sponsors, patients, CRAs, and IRB, maintaining up-to-date protocol and consent form versions across sites.

Competenze

• Demonstrates professionalism and responsiveness when interacting with internal and external customers.
• Advises supervisor or other appropriate individuals of problems or concerns.
• Collaborates effectively with physicians, nurses, and ancillary departments.

Mansioni

• Performs all study-start-up activities – initial IRB Submission, initial FDA Form 1572, initial Financial Disclosure Forms.
• Submits protocol/ICF changes to the IRB in a timely manner.
• Maintains organized files and office space; coordinates sponsor site initiation visits.

Conoscenze

Communication

Organization

Professionalism

Accountability

Regulatory knowledge

Formazione

High school diploma or higher

Strumenti

EMR systems

Descrizione del lavoro

• Location 3901 Parkway Circle, Suite 100, Springdale, AR, 72762, United States


• Job Category research, clinical, regulatory


• Employee Type NonExempt - Full Time


• Manage Others No

Contact information

• Name Brittany M. Mitchell


• Phone [phone]


• Email [e-mail]

Description

Help advance the future of cancer care through clinical research.

We are seeking a detail-oriented and highly organized Research Regulatory Coordinator to play a vital role in ensuring our clinical research studies meet regulatory requirements while supporting groundbreaking advancements in patient care.

Highlands Oncology began in 1996 with three physicians and a desire to change the face of oncology care in our community. Dr. Malcolm Hayward, Dr. Dan Bradford, and Dr. Thad Beck knew that patients do better at home, in the community where they live and work, and where their support system is already in place. In furthering that goal, Highlands has grown with the region from a single location 26 years ago, to 6 locations in Northwest and Northcentral Arkansas today employing more than 800 diverse team members.

As Northwest Arkansas continues to grow, so must the services and providers available in the region. Highlands Oncology is committed to remaining on the cutting edge to ensure our community has access to the very best cancer care. What we have is something quite unique right here in our own backyard with a caring multidisciplinary team focused on treating patients like family.

Job Summary: The Research Regulatory Coordinator is responsible for regulatory documentation and compliance for clinical trials, consistent with good clinical practice guidelines, the Highlands Oncology Group policies and procedures, and sponsor requirements within the assigned setting.

Job Duties / Responsibilities

Protocol Management

• Performs all study-start-up activities – initial IRB Submission, initial FDA Form 1572, initial Financial


• Disclosure Forms, request study access for assigned coordinator and data manager.


• Prepares/maintains protocol files accurately and in a timely fashion.


• Insures most recent protocols, amendments, and memos are on file in the respective offices and on the Research drive.


• Maintains accurate and complete sponsor correspondence files in the regulatory binders.


• Provides support to the data managers and coordinators as requested.


• Coordinates and attends sponsor site initiation visits at office.

IRB Responsibility

• Acts as a contact for all regulatory concerns.


• Submits protocol/ICF changes to the IRB in a timely manner.


• Maintains accurate and complete IRB correspondence files and follow-up actions.


• Insures the most recently approved versions of the ICF are available at each site and on the Research drive.


• Notifies Clinical Research Coordinator of consent form and protocol changes when necessary.


• Submits site related Serious Adverse Events.


• Submits site related protocol deviations, if applicable.

Miscellaneous

• Answers the research department phone.


• Escort Clinical Research Associates from the front lobbies.


• Provide tours when needed.


• Scans source documents into HOG drives and EMR when applicable.


• Posts and tracks training of all new trial materials on SharePoint.


• Scans staff training certificates into the appropriate folders, when needed.

Requirements

Required Skills/Abilities

Communication Skills

• Demonstrates a high level of professionalism and responsiveness when interacting with internal and external customers.


• Advises supervisor or other appropriate individuals of problems or concerns.


• Utilizes appropriate channels of communication in accordance with organizational structure.


• Collaborates effectively with physicians, nurses, and ancillary departments.


• Acts as liaison between PI, sponsor, patient, Clinical Research Coordinator, Research Data Manager, and IRB.


• Communicates routinely with supervisor/liaison regarding start up status.


• Demonstrates effective oral and written communication skills.


• Attends research department meetings when held.

Accountability/Dependability

• Maintains patient/sponsor confidentiality.


• Promptly reports to work at designated times.


• Maintains good attendance with no unexcused absences.


• Follows up on issues as appropriate.


• Supports and adheres to organizational decisions, policies, and procedures.


• Willingly accepts assignments and completes them in a timely manner.


• Attends required meetings/activities.

Organizational Skills

• Maintains organized files and office space.


• Effectively sets priorities.


• Demonstrates flexibility in schedule to accommodate workload.


• Submits routine reports on or before due date.


• Maintains at-a-glance protocol information in office.

Professional Growth and Professionalism

• Demonstrates professionalism in appearance/dress code consistent with policy of HOG.


• Seeks to increase skills through self-directed learning activities.


• Demonstrates initiative in seeking new projects and making corporate-related contributions.


• Willing to take continuing education courses as appropriate.


• Recognizes personal/professional limitations and strives for improvements.


• Acts as team member both corporately and within the individual setting.


• After achieving two years of research experience, it is preferred to test and pass the certification for Certified Clinical Research Professional (CCRP).

Certifications/Licenses/Education/or Experience in a related field

• High school graduate or higher


• Healthcare experience required and clinical research experience


• Knowledge of medical


• Experience with electronic medical


• After two years of research experience, encouraged to obtain Certified Clinical Research Professional (CCRP) certificate.


• Seeks to increase skills through self-directed learning


• Willing to take continuing education courses and participate in conferences as


• Must complete registration with NCI me.

Physical Requirements

• Sitting for prolonged periods of time at a desk.


• Computer use that requires visual acuity, typing, use of mouse/keyboard, and staring at a screen for extended periods of time.


• Occasionally lifting objects of up to 25 pounds such as files, office supplies, assisting patients when needed, etc.


• Walking and standing for continuous periods around the office or clinic as needed.


• Fine motor skills for tasks like typing, writing, handling small objects or equipment and materials.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.


• Due to the nature of our business and the use of radiation and hazardous chemicals, it is imperative that all employees foster a culture and environment of safety.


• Safety Sensitive: In accordance with Arkansas code this position is designated as a safety sensitive position wherein the employee performing the job duties under the influence may constitute a threat to health or safety.

Summary

Highlands Oncology offers a full suite of benefits that includes those pictured below and MANY MORE...

*Certified as a Great Place to Work.