RN Research

Overview:RN ResearchFull-time (Exempt)Methodist Hospital
Promotes good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording, and maintaining data and source documentation.
About UnityPoint Health:Our team members are the compassionate core of who we are and how we serve. Every day we strive to live out our vision statement of “Best outcome every patient every time” through living out our FOCUS values of Foster Unity, Own the Moment, Champion Excellence, and Seize Opportunities.

At UnityPoint Health, we provide care in nine regions throughout Illinois, Iowa, and Wisconsin. As the nation’s fourth largest nondenominational health system in America, UnityPoint Health keeps people at the center of all we do. We are looking for dynamic and talented individuals to join our team. You'll find opportunities for every sized dream.

Want to know about our culture and benefits? Click here to find out more: https://uphtotalrewards.com/.

Responsibilities:

Essential Functions/Responsibilities:

% of Time

(annually)

DOCUMENTS AND MAINTAINS ALL STUDY-RELATED PROCEDURES, PROCESSES, AND EVENTS BY:

• Plans and designs of new forms/source document tools to be used in protocol implementation

• Documents protocol deviations and exemptions

• Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results) as needed

• Abstracts data from medical records, clinic, consultation, and referral notes to study forms and flowsheets

• Records accurate and timely data onto case report forms

• Maintains source documentation for all case report entries, as applicable

• Keys data for electronic submission

• Transmits data via fax, mail or electronically as requested

• Corrects and edits case report form entries as appropriate

• Resolves data queries

• Completes and maintains the study article dispensing log

• Maintains files of all study-related documentation

• Prepares case report forms for sponsor/audit review

• Collects source documents for sponsor/audit review

40%

PARTICIPATES IN SUBJECT RECRUITMENT, ENROLLMENT, AND FOLLOW-UP PROCEDURES BY:

• Monitors enrollment goals and modifying recruitment plan as necessary

• Maintains patient screening/enrollment logs

• Follows patient population clinically and maintains documentation supporting study

• Reviews inclusion/exclusion criteria with investigator to assure subject eligibility

• Reviews and verifying required source documents in subject's medical record to confirm study eligibility

• Assures that all screening, eligibility, and enrollment procedures are performed

• Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects

• Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures

and visits

• Obtains informed consent from research subjects prior to any study-related procedures and documenting

appropriately

• Follows randomization procedures as per protocol

• Dispenses study article as appropriate

• Schedules subjects for follow-up visits

• Reviews diaries and questionnaires completed by subject

• Ensures appropriate specimen collection, batching and shipping as required

• Assesses subject compliance with the test article and follow-up visits

• Recognizes and reporting common laboratory values and alerts to investigator and sponsor

• Protects patient privacy during initial and follow-up interviews

• Secures safe storage of study-related documents

• Assures appropriate disposal of sensitive documents

40%

COMMUNICATES EFFECTIVELY WITH SUBJECTS, RESEARCH TEAM, IRB, AND SPONSOR BY:

• Reviews the protocol requirements with ancillary support staff (i.e. nursing, residents, pharmacist)

• Provides education to staff on current clinical protocols and ensures adherence to study

• Maintains a list of sponsor/CRO contacts for each protocol

• Provides subjects with information about reporting study-related events to research team

• Establishes a mechanism to contact subjects for follow-up visits, new information, etc.

• Utilizes a phone log to document telephone communications

• Contacts primary care providers to discuss/inform of patient enrollment and study progress

• Meets regularly with investigator and research team to discuss subject participation and protocol progress

• Submits protocol amendments and progress reports to IRB in required timeframes

• Completes timely notification of the investigator, sponsor, and IRB of adverse events as outlined in the protocol

and regulations

• Schedules sponsor monitoring visit.

• Meets with monitors/auditors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues.

• Reviews professional publications

10%

PARTICIPATES IN PROTOCOL ASSESSMENT/PLANNING / PRE-INITIATION ACTIVITIES BY

• Assists in determining subject population availability

• Determines equipment and facility availability

• Lists and clarifies questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor

expectations, and study procedures

• Develops timelines for conducting and completing the clinical protocol

• Prepares and submits regulatory documents to sponsor (e.g. Form FDA 1572, laboratory certification and normal

values, curriculum vitae etc.)

• Prepares and submits institutional review board documents

• Integrates proposed clinical trial with current research activities

• Attends and participates in investigator meetings

• Schedules and coordinates pre-study site visit

• Confirms that contact, indemnification letter, IRB approval of protocol and informed consent have been received

prior to study initiation

• Completes Sponsored protocol training including (GCP, EDC, IVRS, IRB, …)

5%

Basic UPH Performance Criteria

• Demonstrates the UnityPoint Health Values and Standards of Behaviors as well as adheres to policies and

procedures and safety guidelines.

• Demonstrates ability to meet business needs of department with regular, reliable attendance.

• Employee maintains current licenses and/or certifications required for the position.

• Practices and reflects knowledge of HIPAA, TJC, DNV, OSHA and other federal/state regulatory agencies guiding

healthcare.

• Completes all annual education and competency requirements within the calendar year.

• Is knowledgeable of hospital and department compliance requirements for federally funded healthcare

programs (e.g. Medicare and Medicaid) regarding fraud, waste and abuse. Brings any questions or concerns regarding compliance to the immediate attention of hospital administrative staff. Takes appropriate action on concerns reported by department staff related to compliance.

10%

Qualifications:

Minimum Requirements

Identify items that are minimally required to perform the essential functions of this position.

Preferred or Specialized

Not required to perform the essential functions of the position.

Education:

Graduate of an accredited nursing program.

Bachelor’s Degree in Nursing (BSN)

Experience:

1-3 years of experience successfully working with a wide variety of people

License(s)/Certification(s):

• Current licensure in good standing as a Registered Nurse in the State of Illinois

• Must possess and maintain current Basic Life Support (BLS) certification.

Certified Clinical Research Coordinator (CCRC)

Knowledge/Skills/Abilities:

• Required English Skills

o Basic reading skills

o Basic writing skills

o Basic oral skills

• Communication Skills

o Ability to respond appropriately to customer/co-worker

o Interaction with a wide variety of people

o Maintain confidential information

o Ability to communicate only the facts to recipients or to decline to reveal information

o Ability to project a professional, friendly, helpful demeanor

• Computer Skills

o Basic Skills

o Word, Excel, Outlook, Microsoft Teams

Other:

• Use of usual and customary equipment used to perform essential functions of the position.

• Work may occasionally require travel to other UPH facilities/hospitals.

• Required to drive your own vehicle for business purposes.