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Clinical Trial Risk Based Monitoring Jobs in Virginia

AbbVie

Clinical Research Associate II

Richmond, VA · On-site +1

$78K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Focus on site clinical research that ensures appropriate conduct of the trial while driving ... Familiar with risk-based monitoring approach, onsite and offsite monitoring. * Knowledge of ...

IQVIA

Clinical Trial Psych Rater

Fairfax, VA · Remote

$62K - $156K/yr

Clinical Trial Psych Rater - US Spanish Speaking Location: Remote/Virtual Hours: Estimated 10-16 ... The actual base pay offered may vary based on a number of factors including job-related ...

New

AbbVie

Clinical Research Associate II

Richmond, VA

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... for continuous risk-assessment proactively, and in collaboration with Central Monitoring team ... based on the health of the site. * Strong interpersonal skills with excellent written, verbal ...

AbbVie

Clinical Research Associate II

Richmond, VA

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... for continuous risk-assessment proactively, and in collaboration with Central Monitoring team ... based on the health of the site. * Strong interpersonal skills with excellent written, verbal ...

Riverside Health System Non-Providers

$68K - $93K/yr

Gloucester, Virginia Hiring Range $68,000.00 - $93,500.00/Annual Actual pay is determined based on ... Maintains all clinical trial documentation according to guidelines. Ensures the randomization ...

Riverside

$68K - $93K/yr

Gloucester, Virginia Hiring Range $68,000.00 - $93,500.00/Annual Actual pay is determined based on ... Maintains all clinical trial documentation according to guidelines. Ensures the randomization ...

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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.

How to become a clinical trial risk based monitoring?

To become a clinical trial risk-based monitor, candidates typically need a bachelor's degree in life sciences, healthcare, or related fields, along with experience in clinical research or monitoring. Certification such as the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) can enhance job prospects. Strong knowledge of Good Clinical Practice (GCP) guidelines and proficiency with electronic data capture (EDC) systems are also important.

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 Trial Risk Based Monitoring jobs near you

Clinical Research Associate II

AbbVie

Richmond, VA • On-site, Remote

$78K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 9 days ago

AbbVie rating

8.6

Company rating: 8.6 out of 10

Based on 101 frontline employees who took The Breakroom Quiz

16th of 86 rated pharmaceutical

Job description

Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities
  • Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie's positioning.
  • Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
  • Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
  • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
  • Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
    Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
  • Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
    May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
  • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
  • Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
  • Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
  • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
    Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
    Manages investigator payments as per executed contract obligations, as applicable.

Qualifications
  • Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
  • Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk-based monitoring approach, onsite and offsite monitoring.
  • Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
  • Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
  • Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
  • Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
  • Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
  • Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
  • Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
  • Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html

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About AbbVie

Sourced by ZipRecruiter

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

North Chicago, IL, US

Year founded

2013

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