Clinical Research Coordinator / Nurse: Must be able to Commute to South Bend, IN

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

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

• Provides clinical research support to investigators to prepare for and execute assigned research studies
• Reviews study protocols, source document forms, other study-specific documents, and electronic data capture systems used to record clinical research data
• Collects and submits regulatory/ethics documentation as required by the Federal Drug Administration (FDA) and other regulatory bodies governing the conduct of the study
• Recruits and screens patients for clinical trials and maintain subject screening and enrollment logs
• Orients research subjects to the study including the purpose of the study, procedures and protocol requirements such as timeline for visits
• Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles
• 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
• Monitors subject safety and report adverse events and reactions to Principal Investigator, study team members  and IRBs as appropriate
• Corresponds with research subjects to troubleshoot study-related questions or concerns
• Participates in routine meetings with site study staff and Investigators to confirm study tasks are assigned and are executed to the expected standards
• Actively involved in study data quality checking and query resolution
• 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
• Updates and maintains site staff skills, training and knowledge of current best nursing practices and topics related to clinical research
• Assists the investigators to safeguard the well-being of subjects and maintain standards required of clinical research sites
• Maintains a safe environment in accordance with site policies
• Acts as an advocate for research subjects
• Addresses subject questions in a pro-active manner and take remedial action as required
• 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
• 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
• Assists in providing training to new investigator site staff members on study-specific topics and requirements
• Maintains adherence to investigator site staff training requirements by auditing and maintaining training records
• 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
• Prepares for and attend study monitoring visits, study audits and regulatory inspections with clinical research regulatory agencies
• 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

Qualifications

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

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Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.