What are the responsibilities and job description for the Clinical Research Associate position at Advanced Clinical?
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Clinical Research Associate in Durham, NC. The Clinical Research Associate role assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols, with supervision. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up
* Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine clinical trial protocol, GCP/ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study
* Prepares telephone contact reports, confirmation letters, site visit reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study
* Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity
* Reconciles clinical supplies and drug accountability records at study sites
* Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required
* Reviews, clarifies, and obtains, data changes via query resolutions with site personnel
* Conducts monitor training
* Tracks study specific tasks and progress of the trial
* Communicates and interacts with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy
* Assists with effective and timely audit/inspection responses
* Performs regulatory document review and approval for IP release
* Monitors processes for distribution and tracking of SAE's, safety documentation, and pregnancies
* Collaborates with data management to resolve queries
* Facilitates investigator site payments, as applicable
* Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation
* Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
* Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). Prepares accurate and complete meeting minutes for various meetings.
To be a best-fit your strengths must include:
* Communication
* Delivering on commitments
* On-site monitoring
* Developing and maintaining strong partnerships
* Staying current with industry trends through continuous learning
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
We are currently searching for a skilled professional to join a well-known client's team as a Clinical Research Associate in Durham, NC. The Clinical Research Associate role assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols, with supervision. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up
* Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine clinical trial protocol, GCP/ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study
* Prepares telephone contact reports, confirmation letters, site visit reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study
* Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity
* Reconciles clinical supplies and drug accountability records at study sites
* Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required
* Reviews, clarifies, and obtains, data changes via query resolutions with site personnel
* Conducts monitor training
* Tracks study specific tasks and progress of the trial
* Communicates and interacts with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy
* Assists with effective and timely audit/inspection responses
* Performs regulatory document review and approval for IP release
* Monitors processes for distribution and tracking of SAE's, safety documentation, and pregnancies
* Collaborates with data management to resolve queries
* Facilitates investigator site payments, as applicable
* Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation
* Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
* Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). Prepares accurate and complete meeting minutes for various meetings.
To be a best-fit your strengths must include:
* Communication
* Delivering on commitments
* On-site monitoring
* Developing and maintaining strong partnerships
* Staying current with industry trends through continuous learning
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
