CLINICAL RESEARCH ASSOCIATE III
CLINICAL RESEARCH ASSOCIATE III
DCRI - Site Support & Management
Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.
Independently oversee and review routine and complex site activities, through monitoring activities, including on-site visits and/or in-house assessments, including telephone contact, and other technologies according to the trial-specific monitoring plan to assess study progress and protocol, regulatory, and SOP compliance; May travel up to 80% to perform all types of routine, unexpected, and complex on-site monitoring visits; Schedule site visits according to DCRI travel policy and trial-specific guidelines maximizing cost and time saving efficiencies.
- Independently perform site monitoring activities for multiple sites and multiple and complex projects, identifying and reporting deviations from regulations and SOPs;
- Critically assess protocol and regulatory compliance, including but not limited to, source document verification, informed consent process and human subject protection, data integrity, drug accountability and compliance, and review of investigator and regulatory files;
- Assess adequacy of site personnel and facilities for study conduct;
- Provide study training and guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations;
- Anticipate potential situations that may affect subject safety or data processes and retrain site personnel to prevent issues.
- Identify action items and discuss with appropriate site personnel;
- Communicate routine and unusual findings to trial supervisor; Document ongoing follow-up and resolution of issues;
- Assist sites with preparation for audits;
- Perform trial supervisory activities as directed by trial manager with approval of line manager;
- Critically assess each site's ongoing activities and continuously coach them to improve their clinical research practices for DCRI trials;
- Serve as senior and/or sole Site Management & Clinical Monitoring study team member;
- Independently document routine and complex site management and clinical monitoring activities, site communication, and trial related activities.
- Recommend revisions to improve efficiencies of monitoring tools, trial documents, and study processes;
- Independently develop and implement study-specific versions;
- Apply knowledge of protocol and study documents and processes, during monitoring activities, including on-site visits and in-house assessments, in response to site activities and inquiries;
- Regularly review and update study and site status information into required systems to maintain accurate, current reports;
- Independently prepare monitoring reports for multiple sites and projects with no more than 1%spelling and grammatical errors;
- Prepare and submit accurate and timely confirmation letters, monitoring reports, follow-up letters and expense reports, in accordance with SOPs and project requirements;
- Review monitoring visit documentation for other team members.
- Maintain essential trial and site communication records, electronic and hard copy, removing non-essential communication to meet organizational and government standards and recommendations;
- Develop and implement action plans for resolution of routine and complex site and study issues;
- Follow up on outstanding issues including ongoing documentation;
- Independently manage and review routine and complex data and data systems, including case report form (CFR) completion and submission, data query resolution, and overall data integrity according to established practices;
- Develop and implement improvements for data collection and data processing.
- Review patient data and source documents;
- Appropriately report safety concerns, protocol deviations or unexpected data trends;
- Review data status reports and follow-up with sites regarding missing and/or late data;
- Observe for trends and proactively train sites for optimal performance;
- Provide training for site personnel on appropriate source documentation, CRF completion, data procedures and timelines, and query resolution;
- Review data queries, assist sites with query resolution and follow up on outstanding queries;
- Build and maintain effective working relationships with site personnel and internal and external study contacts;
- Promote loyalty to DCRI through expert clinical research and good clinical practices.
- Maintain appropriate professional relationships utilizing an assertive, business-like manner which fosters study compliance;
- Develop effective working relationships with difficult sites and other study contacts;
- Provide timely notification to appropriate study contacts of site status and trial related needs;
- Provide clear direction to site and trial personnel on all aspects of the clinical trial while following project guidelines and representing the DCRI and the DCRI's clients;
- Contribute to positive team dynamics through effective listening and verbal communication including active participation in team meetings, interaction with team members, sharing information, and proactive problem identification and resolution; Act as the point person for routine and complex trial-specific activities, working collaboratively with trial team members;
- Independently provide routine updates and complex reports to trial supervisor(s) and other assigned contacts to ensure timely communication regarding status of sites, study issues and resolutions, and trial activities.
- Communicate with teammates to consolidate accurate and complete assessments of sites 'activities;
- Routinely report updates to trial supervisor without prompting;
- Routinely communicate with internal partners as needed for trial activities;
- Independently assess findings and resolve complex issues;
- Serve as an expert resource for CRAs and other team members;
- Independently train and mentor subordinates, peers, and site personnel;
- Train less experienced Site Management & Clinical Monitoring personnel for all types and complexities of monitoring activities and assessments including regulatory and other document activities;
- Develop and implement site training plans and materials, including site initiation activities, agendas, slides, and study tools;
- Provide scientific and technical training to team members based on areas of individual expertise.
1459 CLINICAL RESEARCH ASSOCIATE III
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Work requires graduation from. an accredited degree program providingclinical training as a Registered Nurse (RN), Physician's Assistant(PA) or Pharmacist plus three years of healthcare experience; or one ofthe following equivalents:1. Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, Licensed Practical Nurse) or Associates degree inClinical Trials Research related curriculum plus a minimum of fiveyears healthcare experience; or2.Completion of a master's degree in Public Health,., HealthAdministration or a related area with. two years directly relatedclinical trials research experience; or3. Completion of a bachelor's degree plus a Minimum of three yearsdirectly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of four yearsclosely related research experience.**State of North Carolina license may be required.**
None required beyond that described above.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.