CLINICAL RESEARCH ASSOCIATE II
CLINICAL RESEARCH ASSOCIATE II
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.
Primary Responsibilities and Tasks:
1.Oversee and review routine and moderately complex site activities, with minimal to no guidance, 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 protocol, regulatory, and SOP compliance with some guidance from an experienced CRA or a clinical trial lead.
a. May travel up to 80% to perform on-site monitoring visits, including site selection, initiation, periodic, and close out visits. Perform or assist with unexpected site visits as directed. Schedule site visits according to DCRI travel policy and trial-specific guidelines while effectively using cost and time saving efficiencies.
b. Independently perform monitoring activities for multiple sites and possibly multiple projects, identifying and reporting deviations from regulations and SOPs. 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.
c. Assess adequacy of site personnel and facilities for study conduct.
d. Provide study training and guidance to designated site personnel for conducting studies in accordance with the protocol, SOPs, trial specific procedures and applicable regulations. Identify situations that may affect subject safety or data integrity and retrain site personnel accordingly.
e. 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. Recognize ongoing action items and coach site personnel to improve their performance.
f. Assist sites with preparation for planned and unannounced audits with some guidance.
g. Perform trial supervisory activities as directed by trial project leader with approval of line manager.
2. Independently document routine site management and clinical monitoring activities, site communication, and trial related activities. Document complex site management and clinical monitoring activities, site communication, and trial related activities with minimal to no guidance. Utilize monitoring tools and trial documents, recommend revisions to improve efficiencies of monitoring tools, trial documents, and study processes; independently develop study-specific versions as directed.
a. 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.
b. Regularly review and update study and site status information into required systems to maintain accurate, current reports.
c. Independently prepare monitoring reports for multiple sites and projects with no more than 3% spelling and grammatical errors. Prepare and submit accurate and timely confirmation letters, monitoring reports, follow-up letters and expense reports, using standard templates and forms, in accordance with SOPs and project requirements. Assist trial supervisor with review of monitoring visit documentation for other team members.
d. Maintain essential trial and site communication records, electronic and hard copy, removing non-essential communication to meet trial and organizational and government standards as directed.
e. Develop and implement action plans for resolution of routine and complex site and study issues. Follow up on outstanding issues including ongoing documentation.
3. Manage and review routing and moderately complex site data including case report form (CRF) completion and submission, data query resolution, and overall data integrity according to established practices, with minimal to no guidance. Recommend improvements for data collection and data processing and implement efficiencies as directed.
a. Review specified patient data and source documents. Appropriately report safety concerns, protocol deviations or unexpected data trends.
b. Review data status reports and follow-up with sites regarding missing and/or late data. Observe for trends and coach sites to improve performance.
c. 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.
4. Build and maintain effective working relationships with site personnel, internal and external study contacts. Promote confidence in the Clinical Operations functional group and the DCRI.
a. Maintain appropriate professional relationships utilizing an assertive, business-like manner which fosters study compliance. Develop effective working relationships with difficult sites.
b. Provide timely notification to appropriate study contacts of site status and trial related needs.
c. Provide clear direction to site and trial personnel on all aspects of the clinical trial while following project guidelines and professionally representing the DCRI and the DCRI's clients.
d. 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.
e. Act as the point person for trial-specific activities, working with trial team members as directed by the trial supervisor.
5. Provide routine updates and moderately 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 with minimal to no guidance.
a. Communicate with teammates to consolidate accurate and complete assessments of sites activities. Routinely report updates to trial supervisor without prompting.
b. Routinely communicate with internal partners as needed for trial activities.
c. Independently assess findings and recommend resolution of complex issues, utilizing trial supervisor as a resource to verify proposed plans.
6. Serve as a resource to other team members for day-to-day trial activities. Participate as a trainer and mentor for subordinates, peers, and site personnel.
a. Assist with training less experienced Clin. Ops. personnel for routine on-site monitoring visits and in-house monitoring activities. Document training activities with minimal to no guidance.
b. Develop site training materials, including site initiation activities, agendas, slides, and study tools.
c. Provide scientific and technical training to team members based on areas of individual expertise.
1449 CLINICAL RESEARCH ASSOCIATE II
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, genderidentity, national origin, race, religion, sexual orientation, orveteran 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 two 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 offour yearshealthcare experience; or
2.Completion of a master's degree in Public Health,., HealthAdministration or a related area with. one year directly relatedclinical trials research experience; or
3. Completion of a bachelor's degree plus a Minimum of two yearsdirectly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of three 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.