Clinical Research Associate responsible for monitoring investigator sites, ensuring compliance with ICH GCP and protocol, conducting remote or on-site visits, managing documentation, and facilitating communication between sites and the project team.
Responsibilities
Monitors investigator sites with a risk-based monitoring approach
Ensures data accuracy through SDR, SDV and CRF review
Documents observations in reports and letters
Escalates deficiencies and follows issues to resolution
Maintains regular contact with investigative sites
Requirements
Bachelor's degree in a life sciences related field
Clinical Research Associate – responsible for monitoring investigator sites, ensuring compliance with ICH-GCP, managing documentation, and coordinating with sponsors and investigational sites.
Responsibilities
Monitors investigator sites with a risk-based monitoring approach
Ensures data accuracy through SDR, SDV and CRF review
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters
Escalates deficiencies and issues to clinical management
Requirements
Bachelor's degree in a life sciences related field
Considered as the primary sponsor point of contact for the investigative site. Advanced level of competency in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning.
Responsibilities
Conduct site evaluation, site training, routine on-site and off-site monitoring, 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
Align, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles
Support, guide, and mentor junior personnel on Site Management activities
Customize site engagement strategy for assigned study/ies
Gather local/site insights and utilize site engagement tools to report/track progress and measure impact
Requirements
Medical
Scientific
Pharmacy
Nursing
Nice to have: 2 years in independent clinical research monitoring of investigational drug or device trials
The Manager Clinical Research Monitoring leads the development and implementation of a centralized, risk-based post-approval monitoring program for OSF HealthCare’s research enterprise.
Compensation
Expected pay for this position is $42.64 - $56.50/hour. Actual pay will be determined by experience, skills and internal equity. This is a Salaried position.
Responsibilities
Oversee monitoring and audit activities across active research studies
Ensure compliance with federal regulations, Good Clinical Practice (GCP), institutional policies, and approved study protocols
Partner with Research Administration leadership, investigators, and research teams to identify compliance risks
Strengthen research quality and support safe and effective conduct of clinical research
Requirements
Bachelor’s degree in healthcare, life sciences, nursing, public health, regulatory science, or related field
The Risk Manager (Clinical Research) plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects.
Responsibilities
Provide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs.
Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications.
Coordinate with central monitor team and verify work.
Provide budget recommendations and change orders.
Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT).
Requirements
Bachelor’s degree in a field relevant to clinical research
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