Clinical Research Associate

1 day ago

Durham, North Carolina, United States IQVIA Full time
Job Overview

As a Clinical Research Associate at IQVIA, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibility will be to conduct site management and monitoring visits 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.

Key Responsibilities
  • 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) and 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.
  • Act as a mentor for clinical staff including conducting co-monitoring and training visits.
  • 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 in scientific discipline or health care preferred.
  • Requires at least 4 years of on-site monitoring experience.
  • Equivalent combination of education, training and experience may be accepted in lieu of degree.
  • In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Strong 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.

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://www.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

The potential base pay range for this role, when annualized, is $71,189. 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.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward.

Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

We are an equal opportunity employer and welcome applications from diverse candidates.

  • Clinical Research Associate

    1 day ago

    Durham, North Carolina, United States D2V Clinical Full time

    Job DescriptionThis is a remote position that offers a unique opportunity to make a real difference in the world of Clinical Research.We're looking for a passionate and driven Contract Clinical Research Associate to help us tackle the challenges of early-phase studies and fast-track groundbreaking treatments to patients.As a key member of our team, you will...

  • Clinical Research Physician

    4 weeks ago

    Durham, North Carolina, United States Wake Research Full time

    {"h1": "Clinical Research Physician Job Description", "p": "At Wake Research, we are seeking a highly skilled Clinical Research Physician to join our team. As a Clinical Research Physician, you will be responsible for providing clinical mentorship and leadership for clinical development and clinical trials conduct within our organization. You will operate in...

  • Clinical Research Physician

    1 day ago

    Durham, North Carolina, United States Wake Research Full time

    Job OpportunityM3 Wake Research, an M3USA Company, is seeking a highly skilled Clinical Research Physician to join our team. As a key member of our organization, you will provide clinical mentorship and leadership for clinical development and clinical trials conduct.Key Responsibilities:Provide clinical expertise into the conduct of clinical trialsBuild...

  • Junior Research Associate

    4 days ago

    Durham, North Carolina, United States Eastern Research Group Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Junior Research Associate to join our team at Eastern Research Group. As a Junior Research Associate, you will play a key role in supporting our research projects, working closely with senior staff to design, develop, and optimize solutions.Key ResponsibilitiesAssist in the design, development,...

  • Senior Business Development Associate Lead

    3 weeks ago

    Durham, North Carolina, United States Duke Clinical Research Institute Full time

    Job SummaryDuke Clinical Research Institute (DCRI) is seeking a highly motivated and experienced Senior Business Development Associate Lead to join our team. The successful candidate will be responsible for driving growth, cultivating strategic partnerships, and optimizing the potential of each opportunity to ensure successful outcomes.Key...

  • Clinical Research Associate

    4 days ago

    Durham, North Carolina, United States Fortrea Full time

    Job Title: Senior Clinical Research Associate - OncologyFortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions...

  • Clinical Research Coordinator

    3 weeks ago

    Durham, North Carolina, United States Express Employment Professionals - Durham, NC RTP Full time

    Job Opportunity: Patient Recruitment CoordinatorExpress Employment Professionals is seeking a highly motivated and detail-oriented Patient Recruitment Coordinator to join our team in Durham, NC. This is an 8-month contract opportunity with the potential to extend beyond the initial term.Job Summary:We are looking for a skilled Recruitment Coordinator to...

  • Clinical Research Coordinator

    1 month ago

    Durham, North Carolina, United States Express Employment Professionals - Durham, NC RTP Full time

    Express Employment Professionals is seeking a Patient Recruitment Coordinator for an 8-month contract opportunity in Durham, NC.This full-time position, 40 hours per week, offers a pay rate of $22.25 per hour and a hybrid schedule with at least 1 day per week on-site.As a key member of our team, you will be responsible for the recruitment and enrollment of...

  • Clinical Research Nurse Coordinator

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    Job Title: Clinical Research Nurse CoordinatorJob Summary:Duke University is seeking a Clinical Research Nurse Coordinator to join our team. The successful candidate will be responsible for coordinating and managing clinical research studies, ensuring compliance with regulatory requirements, and providing excellent patient care.Responsibilities:Coordinate...

  • Clinical Research Nurse Coordinator

    1 month ago

    Durham, North Carolina, United States Duke University Full time

    Job Title: Clinical Research Nurse CoordinatorDuke University is seeking a highly skilled Clinical Research Nurse Coordinator to join our team. As a key member of our research team, you will be responsible for coordinating and conducting clinical research studies, ensuring the highest level of quality and integrity in all aspects of research.Key...

  • Clinical Research Associate II with Medical Device Experience

    1 day ago

    Durham, North Carolina, United States IQVIA, Inc. Full time

    Job OverviewIQVIA MedTech is seeking a Clinical Research Associate II with Medical Device monitoring experience. Central Nervous System (CNS) experience is a plus.Key ResponsibilitiesPerform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements.Work with sites...

  • Clinical Research Specialist Senior

    4 days ago

    Durham, North Carolina, United States Duke University Full time

    Job SummaryAs a Clinical Research Specialist Senior at Duke University, you will play a vital role in supporting the conduct of clinical research for the Duke Cancer Institute's GU HUB Clinical Research Program. You will be responsible for performing a variety of research, data, and clerical duties of a routine and technical nature to ensure the success of...

  • Clinical Research Nurse Coordinator

    6 days ago

    Durham, North Carolina, United States Duke University Full time

    Job Title:Clinical Research Nurse CoordinatorJob Summary:We are seeking a highly skilled Clinical Research Nurse Coordinator to join our team at Duke University. The successful candidate will be responsible for coordinating and managing clinical research studies, ensuring compliance with regulatory requirements, and providing exceptional patient care.Key...

  • Clinical Research Nurse Coordinator

    3 weeks ago

    Durham, North Carolina, United States Duke University Full time

    Job Title:Clinical Research Nurse CoordinatorJob Summary:We are seeking a highly skilled Clinical Research Nurse Coordinator to join our team at Duke University. The successful candidate will be responsible for coordinating and managing clinical research studies, ensuring compliance with regulatory requirements, and providing exceptional patient care.Key...

  • Clinical Research Nurse Coordinator

    4 days ago

    Durham, North Carolina, United States Duke University Full time

    Job Title:Clinical Research Nurse CoordinatorJob Summary:We are seeking a highly skilled Clinical Research Nurse Coordinator to join our team at Duke University School of Medicine. As a Clinical Research Nurse Coordinator, you will play a critical role in the day-to-day operations of clinical research studies, ensuring the highest level of quality and...

  • Clinical Research Nurse Coordinator Senior

    1 month ago

    Durham, North Carolina, United States Duke University Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Nurse Coordinator Senior to join our team at Duke University School of Medicine. The successful candidate will provide leadership and coordination for clinical research studies, ensuring the highest level of quality and compliance.Key ResponsibilitiesProvide strategic leadership for clinical...

  • Quality Assurance Associate

    4 weeks ago

    Durham, North Carolina, United States Pharpoint Research Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Associate to join our team at PharPoint Research. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our operations.Key ResponsibilitiesMaintain personnel training files and develop training programs to ensure compliance with SOPs and...

  • Clinical Research Coordinator

    1 month ago

    Durham, North Carolina, United States PSI CRO Full time

    {"Job Title": "Clinical Research Coordinator", "Job Description": "Job SummaryPSI CRO is seeking a Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will be responsible for coordinating a variety of tasks and learning new things while growing with the company.Key ResponsibilitiesCoordinate with project teams to schedule...

  • Clinical Research Nurse Coordinator Senior

    3 weeks ago

    Durham, North Carolina, United States Duke University Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Nurse Coordinator Senior to join our team at Duke University School of Medicine. The successful candidate will provide leadership and coordination for clinical research studies, ensuring the highest level of quality and compliance.Key ResponsibilitiesProvide leadership for a clinical team...

  • Clinical Research Nurse Coordinator Senior

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Nurse Coordinator Senior to join our team at Duke University School of Medicine. The successful candidate will provide leadership for a clinical team conducting multiple, complex oncology clinical trials and research studies.Key ResponsibilitiesProvide strategic leadership for the clinical team,...