Clinical Research Nurse Jobs

Location: Candidates hired into this role will work on site within the Des Moines, Iowa area.

Job Overview
Coordinate and participate in clinical research studies ensuring that studies are carried out according to protocol, contracted scope of work, good clinical practice, sponsor and Avacare standard operating procedures (SOPs) and any relevant local guidelines and regulations.

Essential Functions

• Prepares for and attend study monitoring visits, study audits and regulatory inspections with clinical research regulatory agencies
• Performs a variety of complex clinical research procedures including but not limited to electrocardiogram (ECG), lab sample collection, spirometry, vital signs, dose verifications, cardiac telemetry monitoring, and questionnaire administration
• Collects and submits regulatory/ethics documentation as required by the Federal Drug Administration (FDA) and other regulatory bodies governing the conduct of the study
• Orients research subjects to the study including the purpose of the study, procedures and protocol requirements such as timeline for visits
• Assists investigator in verifying that research study objectives are met on time, within budget and according to application protocol requirements, clinical research regulations and quality standards
• Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles
• Reviews study protocols, source document forms, other study-specific documents, and electronic data capture systems used to record clinical research data
• Provides clinical research support to investigators to prepare for and execute assigned research studies
• Acts as an advocate for research subjects
• Provides guidance and supervision to lower-level site staff to help provide that processes are carried out in line with protocols and SOP's, where applicable
• Participates in study process reviews and enhancement efforts to support control of site unit budget, development of the research facilities and site services and the culture towards a high performing research study team
• Corresponds with research subjects to troubleshoot study-related questions or concerns
• Recruits and screens patients for clinical trials and maintain subject screening and enrollment logs
• Participates in routine meetings with site study staff and Investigators to confirm study tasks are assigned and are executed to the expected standards
• Maintains a safe environment in accordance with site policies
• Assists and advise site staff in nursing practices and on the delivery of study care to subjects
• Reports any deviations from normal research practices to senior staff and implement agreed changes in the study care program
• Actively involved in study data quality checking and query resolution
• Updates and maintains site staff skills, training and knowledge of current best nursing practices and topics related to clinical research
• Adheres to standard operating procedures (SOPs) and other directives throughout this process Assists research site with coverage planning related to staffing and scheduling for research projects
• Schedules and executes study visits and perform study procedures as delegated and supervised by the Principal Investigator
• Handles lab testing and analysis including preparation of specimen collection tubes and lab logistics
• Assists in providing training to new investigator site staff members on study-specific topics and requirement
• Maintains adherence to investigator site staff training requirements by auditing and maintaining training records
• Monitors subject safety and report adverse events and reactions to Principal Investigator, study team members and IRBs as appropriate
• Assists the investigators to safeguard the well-being of subjects and maintain standards required of clinical research sites
• Addresses subject questions in a pro-active manner and take remedial action as required

Qualifications

• 3 years relevant experience Req Or
• Proficient in the use of technology.
• Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
• Sound knowledge of medical terminology.
• Certification of CCRC or CCRP strongly preferred.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Bachelor's Degree Req
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies. e.g., Registered Nurse (RN).
• Skill in carrying out required clinical procedures such as spirometry testing or lab sample collection.
• Sound knowledge of clinical trials.
• In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules.
• Advanced knowledge of the principals of Good Clinical Practices (GCP).
• Ability to maintain confidentiality.
• Equivalent combination of education, training Req

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status