Clinical Research Regulatory Consultant

J  o  b    D  e  s  c  r  i  p  t  i  o  n

          Joy                         Care                      Competence                    Respect

Position Summary

The Clinical Research Regulatory Consultant coordinates and guides the review and approval process of all research activities associated with clinical research studies involving human subjects. This position interprets and applies rules and regulations  and recommends and guides principal investigators (PIs) and research staff in the completion, submission, documenting, and reporting of study activities ensuring appropriate compliance.

Bachelor’s degree in a science, nursing or related healthcare is required.

Master’s degree in healthcare related discipline is preferred.

3 years clinical research experience is required.

3 years clinical research regulatory experience is preferred.

Successful completion of Human Subjects in Research and Good Clinical Practice Training through the Collaborative Institutional Training Initiative (CITI) is required within 30 days of hire. 

Clinical research professional certification (e.g., Certified Clinical Research Associate (CCRA), Association of Clinical Research Professional (ACRP Certified Professional)) is required within 3 years of hire.  A master’s degree in clinical research administration may be considered in lieu of certification.

The ability to demonstrate significant attention to detail, thoroughness, and accuracy while accomplishing work in a timely manner, managing multiple priorities and independently meeting deadlines.

Ability to apply critical thinking skills and demonstrate initiative to independently address problems and identify solutions.

Ability to professionally represent the organization with external constituents; utilizes articulate and responsive written and verbal and communication skills.

Demonstrates proficiency and comfort in navigating and self-learning various software applications and web-based systems.

Exhibits excellent organizational and coordination skills and enjoys the structure of a highly regulated environment.

Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines.

Manages ongoing regulatory compliance by methodically monitoring research base/study broadcasts for update notifications, processing and implementing all study amendments, addendums, updates and submitting Institutional Review Board (IRB) reviews in required time frames and updating required documentation with National Cancer Institute (NCI) and other study sponsors.

Serves as primary liaison for NCI, industry representatives, medical science liaisons and contract research organizations (CRO) to assess upcoming study opportunities, coordinate study start up documentation, visits and activities, oversee data quality and submission timeliness for studies; responds to study queries & notifications or directs to appropriate staff.

Maintains integrity of institutional archive of all study specific documentation (i.e., consents, HIPAA documents, regulatory approvals, clinical trial and confidentiality agreements, approved budgets, sponsor communications, protocols, investigator specific documents) throughout the life of the study.

Oversees training and rostering of providers and colleagues involved in research by providing orientation on regulatory requirements; supports, guides and monitors completion of initial and ongoing training requirements (i.e., GCP, human subjects, study specific); ensures maintenance of electronic records; and completes required research base specific onboarding documents. 

Assesses feasibility of studies by obtaining and interpreting relevant data; interprets care plans and pathways to assess alignment with or contrast to proposed studies; assesses financial parameters of industry sponsor budgets & Medicare Coverage Analysis (MCA) for local feasibility and sponsor-paid activities.  Collaborates with external consultant on study budget negotiations.  Makes recommendations to leadership on study selection.

Identifies and supports quality improvement initiatives and coordinates process improvements to resolve study concerns or problematic departmental processes. Leverages clinical trial management system (CTMS) functionality; works with CTMS vendor to resolve identified system issues or requested enhancements.

Coordinates startup activities ensuring all required applications and regulatory approvals are completed prior to study initiation.  Assists with acquisition and management of study supplies; serves as unblinded research staff as needed. Builds financial parameters of clinical trial agreements into the clinical trial management system (CTMS) to ensure study-paid activities are accurately documented for invoicing and billing compliance.

Interfaces with regulatory/governing bodies before and during audits and monitoring of studies (including NCI, pharmaceutical study sponsors, CROs, FDA, etc.); organizes logistics and patient data access for on-site and/or virtual monitor visits and provides guidance to department staff for audit preparation; coordinates with consortium partners as applicable. Responds to audit findings by drafting and submitting required corrective and preventative action plans, with input from research team, investigator and relevant stakeholders as necessary.

Actively supports the NCORP Consortium, research affiliates and ancillary departments involved in research (i.e., pharmacy, radiology, pathology); analyzes and facilitates necessary credentialing and site activations or transitions, and completion of study-specific regulatory requirements.

Collaborates with ancillary departments on research reporting, coding & billing functions.

Possess the information, skill, and understanding of the work to be performed.  Actively participates in continuing education opportunities and maintains certifications, licensure as appropriate.

Abides by all safety requirements including demonstrating proper hand hygiene and wearing of Personal Protective Equipment (PPE), if applicable. 

Complies with all standards, policies and procedures including dress code, attendance and punctuality.  Attends required in-services and meetings and completes all mandatory competencies by deadline. Commits to keeping all patient, student or colleague information confidential and maintains ongoing communication and collaboration with team members. 

The purpose of this job description is to provide a summary of the major responsibilities performed by colleagues in this position. Colleagues may be requested to perform tasks other than those specifically presented in this job description.  Variances in job duties performed may exist between facilities, and colleagues may perform other related duties as assigned to meet the needs of the organization.

PHYSICAL, MENTAL AND ENVIRONMENTAL REQUIREMENTS

Physical, Mental and Environmental Requirements Category:

Administrative

Standing

X

Walking

X

Sitting

X

Lifting

X

20 lbs.

Carrying

X

20 lbs.

Pushing

X

20 lbs.

Pulling

X

20 lbs.

Climbing

X

Balancing

X

Stooping

X

Kneeling

X

Crouching

X

Crawling

X

Reaching

X

Use of Hands/Dexterity

X

Talking

X

Hearing

X

Eye/Hand/Foot Coordination

X

Extreme Cold

X

Extreme Heat

X

Humid

X

Wet

X

Noise

X

Hazards

X

Temperature Change

X

Atmospheric Conditions

X

Vibration

X

Other