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5PY US Quintiles, Inc.

Registered Nurse for Clinical Research

Full-time

San Angelo, TX, United St...

Health / Beauty / Fitness

9 months ago

Job OverviewSupport study sites in the coordination of Phase I-IV clinical research studies, ensuring that studies are carried out according to protoc.....

Job Overview
Support study sites in the coordination of Phase I-IV clinical research studies, ensuring that studies are carried out according to protocol, standard operating procedures, GCP, and other applicable guidelines and regulations.

Essential Functions
• Coordinate clinical research studies conducted by a supervising principle investigator.
• Update and maintain skills, training and knowledge of current best nursing practice and topics related to clinical research.
• Safeguard the well-being of the subjects and ensure and maintain high standards:
• Maintain a safe environment in accordance with the Health and Safety policies
• Act as volunteer advocate
• Deal with volunteer and visitor concerns in a pro-active manner and taking remedial action as required
• Assist staff, both registered and unregistered in Nursing Practices and the delivery of care to the volunteer
• Report any deviation from normal practice to senior staff.
• Support study conduct by:
• Review of the study protocol, case report form (CRF), other study documents, and electronic data capture systems
• Participate in project meetings with the project team as needed
• Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents
• Plan logistical activity for procedures as per protocol
• Generate volunteer instructions
• Identify and obtain required supplies and equipment
• Prepare and deliver study specific training materials, documents, and records
• Troubleshoot study issues
• Participate in huddles to ensure daily tasks are assigned to team members are executed to the expected standards
• Assist with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness.
• Recruit and Screen volunteers for inclusion in study based on pre-determined criteria.
• Orientate volunteers to the study and the site including the purpose of the study, procedures and practical issues such as timelines for visits.
• Responsible for the correct administration and custody of study drug according to site standard operating procedures.
• Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including phlebotomy, spirometry, vital signs, cannulation, and cardiac telemetry monitoring.
• Collect, record, and report clinical data and findings appropriately in case report forms (CRFs). Collaborate closely with study investigator informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
• Cooperate with study monitor and reserve sufficient time for questions during monitoring.

Qualifications
•
• 1 year relevant experience.
• r equivalent combination of education, training and experience.
• Good knowledge of clinical trials.
• In-depth knowledge of the principles of Good Clinical Practices (GCP).
• Good skill in using MS Windows and Office applications.
• Effective written and verbal communication skills including good command of the English language.
• Excellent interpersonal skills.
• Excellent problem-solving skills.
• Effective organizational skills.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Current active nursing license in the state, country, or region in which the site resides.

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

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

The potential base pay range for this role, when annualized, is $59,500.00 - $110,500.00. 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.

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5PY US Quintiles, Inc.

Clinical Research Associate - Sponsor Dedicated

Full-time

Durham, North Carolina, U...

Education / Training

9 months ago

Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the.....

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Some organizations require completion of CRA training program or prior monitoring experience.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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

The potential base pay range for this role, when annualized, is $73,780.00 - $174,468.00. 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.