Research Quality and Regulatory Specialist (Biotech)

The Research Quality and Regulatory Specialist will support the department by ensuring adherence to regulatory standards, procedural compliance, and the maintenance of quality systems within the Research department. in accordance with local and Federal regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans.

JOB SPECIFIC DUTIES AND RESPONSIBILITIES:

Seeks current information and maintains current knowledge base to analyze and interpret applicable regulations (federal and local laws, guidance, ICH-GCP, Revised Common Rule, 46 CFR 46, standards for accreditation, etc.)
Assists with the development of new SOPs and reviews and provides revisions of current research SOPs as needed.
Conducts regular audits to identify potential deviations from study protocol or regulatory documents in compliance with local, state, and federal regulations.
Prepares quality management reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives.
Assists with compliance and quality assurance issues and supports external regulatory site visits, providing regulatory input to minimize potential for non-compliance findings.
Evaluates study protocols, informed consent forms, and other essential documents to ensure compliance with regulatory requirements and site standards.
Reviews the collection and documentation of data from clinical trial patient visits.
Performs regulatory management of clinical trials, which may cover submission in the study startup phase through study closeout.
Prepare, track, and maintain all correspondence and documentation required by the IRB, FDA, and other institutional oversight committees as appropriate for the clinical trials to which they have been assigned.
Prepares timely submissions of regulatory documents to Sponsor and Central IRB as appropriate.
Maintain clinical trial regulatory compliance with GCP, institutional, and federal regulations.
Collaborates with clinical trial coordinators and leadership to maintain up to date clinical trial documentation and retraining.
Maintains Investigator Site File (ISF) within eRegulatory system and legacy binders.
Maintain timely continuing review (CR) submissions.
Prepare regulatory materials for monitoring visits; serve as primary point of contact for scheduling monitor visits and set calendar holds for finalized visit dates. Includes access to eRegulatory training and study visit log requests for Clinical Research Assistant's (CRAs).
Exercises appropriate judgement in evaluating audit findings while reporting regular updates of non-compliance of all severities to supervisor.
Documents and develops corrective or preventative action plans in a timely manner.
Provides guidance and training to research staff to ensure compliance with rules and regulations associated with the department's clinical research studies.
Monitor IRB communications within the electronic portals.
Assists in submission of Emergency Use or Investigational New Drug (IND) applications including amendments and reporting.
Develops and maintains quality assessment standards, tools, and procedures to conduct internal audits.
All other duties as assigned.

SUPERVISORY RESPONSIBILITY: None

EDUCATION, CERTIFICATION, LICENSURE, REGISTRATION:

Bachelor's degree in a scientific discipline or related field; OR equivalent combination of education and experience.

Master's degree preferred.

Minimum 2-5 years of experience in clinical research regulatory and research quality or related role within healthcare.
CCRP or CCRC certification within 6 months of exam eligibility.

EXPERIENCE, KNOWLEDGE, SKILLS and ABILITIES:

Experience conducting audits and assessments in a clinical research setting.
Thorough understanding of regulatory requirements and guidelines (e.g., GCP, ICH, FDA regulations).
Demonstrate working knowledge of Quality Assurance and Quality Control procedures in a clinical research environment.
Demonstrate technical competency, knowledge, and ability to analyze, plan and support QA/QC programs and services.
Knowledge of clinical research methodologies, protocols, and regulatory requirements.
Strong attention to detail and analytical skills.
Proficiency in interpreting and applying regulatory guidelines.
Must be proficient with Microsoft office applications (Outlook, Word and Excel).
Must be capable of recognizing, and have the willingness, to resolve errors and issues;
Must possess a high degree of integrity and the ability to maintain the utmost confidentiality in all company matters.
Excellent communication and interpersonal skills for effective collaboration with diverse teams.
Ability to work independently, prioritize tasks, and manage multiple projects simultaneously.
Proficient in utilizing various software tools and databases for documentation and data analysis.

REASONING ABILITY:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, or schedule form.

INTERPERSONAL SKILLS:

Must interact and communicate both verbally and in written form.
Must interact and exchange information regarding patients with physicians and other departmental personnel, and outside agencies on a frequent basis while respecting the confidentiality of patient information.

PHYSICAL DEMANDS:
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.

While performing the duties of this job, the employee is regularly required to talk or hear.
The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms.
Specific vision abilities required by this job include close vision and the ability to adjust focus.

WORK ENVIRONMENT:
The work environment described here are representative of those an employee encounters while performing the essential functions of this job. This position involves potential exposure to infectious diseases. Colleagues are offered appropriate vaccinations and safety training.

COMMENTS:
This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of the job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

SAFETY SENSITIVE
This position is a Safety Sensitive Position. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.