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Job Title: Clinical Trial Nurse – Norwich, CT

Work Set-Up: Onsite support.
Scheduled Weekly Hours: 34 hours

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 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
• Assist 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 proactive 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
• Assist 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 project

We are looking for candidates with the following skills and experience:

• Bachelor's degree preferred or associates required minimum in Nursing and one-year relevant experience, or equivalent combination of education, training and experience
• Knowledge of clinical trials, combined with in-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules preferred not required
• BLS certification
• Basic knowledge of medical terminology
• Experience in the field of mental health would be a plus
• Strong IT competence, skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
• Excellent interpersonal skills with the ability to establish and maintain effective working relationships with co-workers, managers and clients
• Good organizational skills with the ability to pay close attention to detail.
• Strong communication skills

Please note, this position is not eligible for sponsorship.

#LI-CES and #LI-DNP #LI-HCP #ONSITE

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role is $50.00-$60.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.