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Clinical Trial Risk Based Monitoring Jobs in Virginia

Current Registered Nursing License for the state the role is based in for RN's * Oncology experience preferred * Clinical trial experience preferred Why Join Us? At NEXT Oncology (an Avacare Business ...

Management of Clinical Trial Patients * Provides complete patient assessment, including vital signs ... Ensures evidence-based symptom management as permitted by the protocol * Patient health counseling ...

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Clinical Trial Risk Based Monitoring information

How does a Clinical Trial Risk Based Monitoring professional typically collaborate with cross-functional teams during a study?

In a Clinical Trial Risk Based Monitoring role, you will regularly work with clinical research associates, data managers, statisticians, and regulatory teams to identify and address potential risks throughout a study. Collaboration often involves participating in meetings to review data trends, sharing insights about site performance, and helping to develop mitigation strategies. Effective communication is crucial, as you will be responsible for ensuring that all stakeholders are informed of key risks and recommended actions. This collaborative environment helps drive patient safety, data integrity, and overall trial success.

What is the difference between Clinical Trial Risk Based Monitoring vs Clinical Trial Data Manager?

AspectClinical Trial Risk Based MonitoringClinical Trial Data Manager
Primary FocusMonitoring trial sites for risks and complianceManaging and ensuring accuracy of trial data
Required SkillsMonitoring protocols, regulatory knowledge, site managementData management, database systems, quality control
Work EnvironmentClinical sites, monitoring visits, remote oversightData centers, clinical trial databases, office setting
CertificationsGCP, monitoring certificationsCDMP, data management certifications

While both roles are integral to clinical trials, Risk Based Monitoring focuses on overseeing site performance and compliance to mitigate risks, whereas Data Managers concentrate on managing and validating trial data for accuracy and integrity.

What is Clinical Trial Risk Based Monitoring?

Clinical Trial Risk Based Monitoring (RBM) is a strategy used in clinical research to prioritize and focus monitoring activities on the most critical risks to patient safety and data integrity. Instead of monitoring every data point equally, RBM uses data analytics and risk assessment tools to identify which sites, processes, or data require more attention. This approach increases efficiency, reduces costs, and helps ensure that potential issues are detected and addressed promptly. RBM is supported by regulatory agencies and is increasingly adopted in both large and small clinical trials.

What are the key skills and qualifications needed to thrive in Clinical Trial Risk Based Monitoring, and why are they important?

To thrive in Clinical Trial Risk Based Monitoring, you need expertise in clinical research, regulatory compliance, and data analysis, usually supported by a degree in life sciences or related fields. Familiarity with risk assessment tools, EDC (Electronic Data Capture) systems, and GCP (Good Clinical Practice) certification is typically required. Strong attention to detail, critical thinking, and effective communication help professionals proactively identify and address potential risks in trials. These skills are crucial for maintaining data integrity, ensuring patient safety, and optimizing the efficiency and quality of clinical studies.
What are popular job titles related to Clinical Trial Risk Based Monitoring jobs in Virginia? For Clinical Trial Risk Based Monitoring jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Clinical Trial Risk Based Monitoring jobs in Virginia look for? The top searched job categories for Clinical Trial Risk Based Monitoring jobs in Virginia are:
What cities in Virginia are hiring for Clinical Trial Risk Based Monitoring jobs? Cities in Virginia with the most Clinical Trial Risk Based Monitoring job openings:
Clinical Nurse

Clinical Nurse

IQVIA

Fairfax, VA • On-site

Full-time

Posted 29 days ago


IQVIA rating

8.1

Company rating: 8.1 out of 10

Based on 53 frontline employees who took The Breakroom Quiz

53rd of 207 rated it services


Job description

Job Summary

Positions available on-site in Irving, TX and Fairfax, VA


Job Summary

The Clinical Nurse must be knowledgeable of standard research and oncology care practices. The Clinical Nurse advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care.

Essential Duties and Responsibilities

Essential Duties and Responsibilities Essential and other important responsibilities and duties may include but are not limited to the following:

Protocol Compliance

  • Adheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research.

  • Complies with NEXT Oncology SOPs

  • Participates in providing timely, informative, and accurate communication with the interdisciplinary team to ensure protocol compliance and timeliness of protocol-related procedures

  • Collaborates with the PI, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs

Informed Consent

  • Identifies and intervenes to address barriers to effective informed consent discussions and decision making (e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception)

  • Describes and abides by institutional policy and processes for informed consent

  • Assesses patient's understanding of the information provided during the informed consent process

  • Ensures timely re-consenting as needed by the physician investigator.

  • Confirms informed consent is obtained prior to performing any study specific tasks.

Management of Clinical Trial Patients

  • Provides complete patient assessment, including vital signs and pre-examination procedures

  • Gathers and assess objective and subjective data from the patient

  • Documents data and assessments accurately in the patient record

  • Assists the providers in all aspects of the consultation, treatment, procedures, and follow-up care

  • Records medical history and symptoms, completing documentation in the medical record

  • Coordinates patient care, acting as a liaison with other departments and organizations

  • Provides patient education before and after procedures, use of medical devices and equipment, and prescriptions

  • Triage of calls for urgent appointments, referrals for patient consults and resting, insurance precertification, and documentation

  • Educates the patient and family regarding clinical condition and/or disease process

  • Ensures timely completion of protocol-required events and other requirements (e.g. pharmacokinetics or-dynamics, scans, study visits, QOL.)

  • Assesses individual patients for physical, psychosocial, and financial factors that could impact adherence with study requirements and implement interventions as necessary

  • Evaluates patient's adherence to and documentation of self-administered protocol agents and the return of such agents

  • Collaborates with the investigator to determine disease response as defined by the protocol and communicates findings to the study team and other care providers

  • Evaluates patient's adherence to and documentation of self-administered protocol agents and return of such agents

  • Collaborates with the investigator to determine if any treatment schedule or drug dose modification is necessary and communicates findings to the study team and other care providers

  • Ensures appropriate communication between clinical and research staff related to patient-specific care needs

  • Ensures evidence-based symptom management as permitted by the protocol

  • Patient health counseling and instruction, including meeting with families and caregivers

  • Medication reconciliation, management, patient compliance, inventory, education

  • Ensures regulatory compliance with OSHA guidelines, CLIA regulations, HIPAA medical privacy guidelines

Documentation and Document Management

  • Documents all patient encounters in the legal medical record per licensure and institutional requirements

  • Obtains documents from outside providers or laboratories that are needed

  • Assesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents

  • Maintains the privacy and confidentiality of patient's source documents

  • Other duties as assigned

Required Education and Experience

  • Current BLS and ACLS or obtained within 90 days of employment

  • Current Registered Nursing License for the state the role is based in for RN's

  • Oncology experience preferred

  • Clinical trial experience preferred

Why Join Us? At NEXT Oncology (an Avacare Business), you'll be part of a mission-driven team that values collaboration, precision, and patient safety. Our team is known for its supportive culture, strong communication, and commitment to excellence in clinical research.

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 athttps://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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $62,700.00 - $156,700.00. 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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About IQVIA

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At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Durham, NC, US