Clinical Research Nurse Study Coordinator (32490)

GI Alliance; Peoria (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

GI Alliance seeks an Experienced Research Nurse to mentor staff and lead complex clinical trials within a growing research department. You will ensure protocol adherence, regulatory compliance, and high-quality data collection while collaborating with PIs and Sub-Is.

You will oversee study start-up and site operations, train Coordinators, assist with recruitment, manage adverse events, and maintain CTMS/EMR systems, fostering efficient, compliant trial execution across multiple sites.

Qualifications

• Must have 4–6 years of experience conducting complex therapeutic area clinical trials.
• RN or LVN license in applicable state.
• Urology-based clinical experience preferred.
• Knowledge of FDA, GCP, ICH and federal/state regulations.
• Proficiency with EMR and Practice Management systems.
• ACRP certification (preferred).

Responsibilities

• Support building the research department in scope, size, reputation, and professionalism.
• Lead recruitment of studies with central recruitment team.
• Maintain knowledge of FDA, GCP, ICH, and regulatory requirements.
• Obtain and maintain consent of patients with high ethical standards.
• Screen, interview, and perform exams including EKG, blood draw, vitals.
• Work with EMR and data management systems to complete data and source requirements.
• Oversee daily operations and training of staff; manage multiple studies.

Skills

Trial management

Mentoring

Regulatory compliance

Urology experience

Communication

Education

RN or LVN license

ACRP certification (preferred)

Tools

CTMS

EMR/Practice Mgmt systems

Job description

Experienced Research Nurse who plays a key role in supporting the growth of an expanding research department. Responsible for mentoring and training less experienced staff, ensuring adherence to protocols and regulatory requirements. Provides advanced expertise in managing complex clinical trials and contributes to process improvements to optimize study efficiency. Works closely with Principal Investigators (PIs) and Sub-Investigators (Sub-Is) on various studies. Collaborates within a large, motivated private practice, ensuring the department’s success in delivering high-quality research.

Job Relationships

• Reports to the Director of Clinical Research, Vice President of Research, Regional Market President, and the physicians at the local market
• Collaborates with experienced patient navigators, IT, data management, and Urology Alliance clinical research staff.
• Urology experience preferred

Qualifications

• Independently manages significant and all key aspects of complex clinical trials
• Exhibits advanced expertise in the execution and oversight of complex clinical trials, ensuring adherence to protocol, regulatory standards, and timely documentation.
• Accurately reports visit details and trial activities to ensure proper revenue tracking and timely invoicing.
• Develops effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials.
• Able to manage multiple studies with varying indications.
• Leads complex, multi-site trials, ensuring compliance with protocol and regulatory requirements.
• Mentors Clinical Research Coordinators I and II, Research Assistants, and Research Interns providing guidance during new hire training, trial initiations, and transitions.
• Oversees work performed by Research Assistants and Research Interns as needed.
• Must have knowledge of and experience with relevant federal and state regulatory guidelines.
• Must have at least 4-6 years of experience with conducting complex therapeutic area clinical trials.
• Urology based clinical experience preferred. Willingness to perform urology required procedures to conduct urology research.
• Certification via ACRP or the equivalent preferred.
• Current, unrestricted Registered Nurse (RN) or Licensed Vocational Nurse (LVN) license required in the applicable state of practice.
• Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
• Excellent time management and prioritization skills.
• Strong communication skills and ability to interact with all levels of management, staff, physicians, CROs, sponsors, and vendors.

Essential Job Responsiblities

• Support building the research department in scope, size, reputation, and professionalism.
• Leads the recruitment of studies with the central recruitment team and champions recruitment goals.
• Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
• Obtain and maintain consent of patients with the highest ethical standards.
• Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc.
• Communicate with and support patients end to end during trial participation and their families as necessary.
• Work with the EMR and data management systems to complete all data and source requirements for visits.
• Must have or gain knowledge of relevant software/programs, including a CTMS.
• Have a mastery level of working knowledge of trial design, statistical methods, etc.
• Triage, record, and report adverse events. Record and report any protocol deviations.
• Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls.
• Directly work with the Regional Manager and Research Director to assist overseeing all daily operations and implementation of policies and procedures in the department.
• Maintain HIPAA compliant communication and confidentiality, at all times.
• Participate in site visits, SIVs, monitoring, etc.
• Complete necessary study close-out steps and documentation.
• Conduct blood draws and laboratory procedures as required per study.
• Manage IP accountability and perform drug dosing and instillations per study requirements.
• Assist with other duties assigned.

Performance Requirements

Knowledge

• Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices.
• Understanding of medical terminology.

Skills

• Ability to use multi-line phone systems and basic computer systems.
• Interpersonal communication with internal staff and external customers.
• Skill in reading medical chart terminology.
• Time Management.
• Phlebotomy

Abilities

• Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
• Elicit appropriate information for patients to clinic staff.
• Ability to read and understand information and ideas presented in writing.
• Ability to apply general rules to specific problems to produce answers that make sense - deductive reasoning.

Physical Demands And Work Environment

• Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.
• Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.

GENERAL SIGN-OFF: The employee is expected to adhere to all company policies. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position. I agree that I have received a copy of this job description and understand the requirements of the position of Clinical Research Nurse Study Coordinator II.