Clinical Research Regulatory Coordinator I at Eastern Nephrology Associates

New Bern, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Aug, 26

Salary

22.6

Posted On

07 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Documentation, IRB Submissions, Good Clinical Practice (GCP), Recordkeeping, Clinical Research, Microsoft Office, Written Communication, Verbal Communication, Organization, Attention To Detail, Time Management, Compliance Monitoring

Industry

Medical Practices

Description

You’re not just applying for a job - you’re stepping into a role that matters and where YOU matter. Ready to lead with purpose and make a lasting impact? Eastern Nephrology Associates is looking for a dedicated professional to join our team and help drive excellence across our organization. In this role, you'll play a key part in supporting operations, collaborating with teams, and ensuring the highest standards of service and care. If you're a motivated, organized individual with strong leadership skills and a passion for making a difference—this could be your next big move! Summary: To serve as a clinical research regulatory coordinator during the conduct of clinical research at the investigative site. Works under the direct supervision of the Principal Investigator. The Clinical Research Regulatory Coordinator I provides support for clinical research studies conducted at ENA investigative sites. This position assists with the preparation, submission, maintenance, and organization of regulatory documentation in accordance with applicable federal and state regulations, sponsor requirements, and ENA policies. The role works under the direction of the Director of Clinical Research, with functional oversight from the Principal Investigator, and supports the ethical and compliant conduct of research consistent with ENA’s mission, vision, and values. Qualification Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required Education and Experience * High School Diploma or equivalent required. * Minimum of 2–4 years of healthcare and/or clinical research experience, or an equivalent combination of education and experience. * Paralegals strongly encouraged to apply. * Ability to maintain confidentiality of sensitive patient, research, and organizational information. Preferred Qualifications * Associate’s degree (AA) in healthcare, science, or a related field preferred. * Prior experience supporting regulatory activities in a clinical research environment. Familiarity with Good Clinical Practice (GCP) and basic regulatory requirements. Knowledge, Skills, and Abilities * Strong organizational and recordkeeping skills with attention to detail. * Ability to manage multiple tasks and meet deadlines. * Effective written and verbal communication skills. * Proficiency with personal computers and standard office software, including Microsoft Office and email systems. * Ability to follow established policies, procedures, and direction. * Ability to work independently and collaboratively in a fast paced environment. Demonstrated professionalism and ability to model ENA’s mission, vision, and values. Supervisory Responsibilities: None Essential Duties and Responsibilities (Percentages reflect estimated time allocation and total 100%.) * Regulatory Document Preparation and Maintenance – 50% * Assist with the collection, preparation, and maintenance of regulatory documents for assigned clinical research studies. * Assist with regulatory components of study startup activities, including collection of investigator and site documentation. * Support ongoing regulatory maintenance throughout the study lifecycle. * Maintain accurate, complete, and organized regulatory binders and electronic regulatory files. * Track required regulatory documentation and ensure timely updates and renewals as directed. * IRB and Regulatory Submissions Support – 25% * Assist with the preparation and submission of IRB applications, amendments, continuing reviews, reportable events, and study closures under supervision. * Track IRB approvals, correspondence, and submission deadlines. * Communicate submission status to research leadership and study staff as appropriate. * Compliance and Quality Support – 15% * Support compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), FDA regulations, and ENA policies and procedures. * Assist with internal monitoring activities, audits, and inspections by organizing regulatory documentation and responding to requests as directed. * Escalate potential regulatory or compliance issues to the Director of Clinical Research or Principal Investigator. * Other Duties – 10% * Perform other related duties as assigned to support the Research Department. Total: 100% Physical Demands * Hearing, balancing, handling, and talking and requires full range of body motion. * This position requires visual acuity sufficient for computer and document review (corrected or uncorrected) Reaching, grabbing, holding – fine motor skills with dexterity and eye-hand coordination * Lift or move up to 30 pounds. Employee is expected to use appropriate ergonomics and tools such as hand carts for heavier loads. * Primarily administrative and office based work. * Prolonged periods of sitting and working at a computer. * Frequent use of hands for keyboarding and document handling. * Occasional lifting or moving of materials up to 30 pounds using appropriate ergonomic techniques and equipment. Work Environment * The noise level is usually moderate. * Moderate risk of exposure to blood-borne pathogens and OPIM. * Work is performed in a typical office and clinical research environment. * Hybrid work arrangement with onsite presence required as business needs dictate. * Noise level is generally moderate. Travel Requirements * Occasional local travel to ENA sites or offsite meetings as required. * Valid driver’s license and reliable transportation required. Disclaimer The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required for the position. All employees may have other duties assigned at any time. This position falls under a 180- day evaluation review period. To request a reasonable accommodation for any part of the application or hiring process, please see our Accessibility Statement or contact Human Resources at hr@easternnephrology.com [hr@easternnephrology.com] or 252-864-2049.

Responsibilities

The role focuses on the preparation, submission, and maintenance of regulatory documentation for clinical research studies. It involves supporting IRB applications and ensuring compliance with GCP, FDA, and ICH regulations.