Christie Carter
Saraland
Summary
Seasoned Senior Clinical Research Associate with background in managing and overseeing clinical trials. Previous roles have demonstrated strong leadership skills, efficiency in monitoring activities related to clinical studies, and ability to maintain high-quality standards for all research projects.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate III
IQVIA Drug Development
Durham
05.2023 - Current
- CRA has worked for only one sponsor in a Full-Service Provider CRA Role for the entire time employed with IQVIA.
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
- CRA has developed and maintained close relationships with the sponsor and assigned sites during this assignment.
- General On-Site Monitoring Responsibilities:
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitor data for missing or implausible data.
- Ensure the resources of the sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.
- Ensure audit readiness at the site level.
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports.
- Manage small projects under direction of a Project Manager/Director as assigned.
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Organize and make presentations at Investigator Meetings.
- Participate in the development of protocols and Case Report Forms as assigned.
- Participate in writing clinical trial reports as assigned.
Senior Clinical Research Associate II
Labcorp Drug Development
Durham
06.2022 - Current
- The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; consult with vendors; and other duties, as assigned.
- Responsible for all aspects of site management as prescribed in the project plans.
- General On-Site Monitoring Responsibilities:
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitor data for missing or implausible data.
- Ensure the resources of the sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.
- Ensure audit readiness at the site level.
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports.
- Manage small projects under direction of a Project Manager/Director as assigned.
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Organize and make presentations at Investigator Meetings.
- Participate in the development of protocols and Case Report Forms as assigned.
- Participate in writing clinical trial reports as assigned.
- Interact with internal work groups to evaluate needs, resources, and timelines.
- Function as contact for clinical trial supplies and other suppliers (vendors) as assigned.
- Responsible for all aspects of registry management as prescribed in the project plans.
- Undertake feasibility work when requested.
- Conduct, report and follow-up on Quality Control (QC) visits when requested.
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned.
- Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.
- Assist with training, mentoring and development of new employees, e.g., co-monitoring.
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may function as a local client contact as assigned.
- Perform other duties as assigned by management.
Senior Clinical Research Associate
ICON Clinical Research
Brentwood
02.2021 - 06.2022
- Identified, selected, initiated, and closed out appropriate investigational sites for clinical studies.
- Monitored those sites to ensure that studies were conducted according to the study protocol, ICON SOPs/WPs, applicable regulations, and the principles of ICH-GCP.
- Depending upon experience, became involved, when required, in other areas of study management and staff training and contributed to the review of ICON systems and procedures as appropriate.
- Provided a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Senior Clinical Research Associate I
Covance (acquired by Labcorp)
Princeton
03.2020 - 02.2021
- Previously responsible for all aspects of study site monitoring including routine monitoring and closed out visits, maintained study files, conducted pre-study and initiation visits; liaised with vendors; and other duties, as assigned.
- Previously responsible for all aspects of site management as described in the project plans.
- General on-site monitoring responsibilities were to ensure the study staff who will conduct the protocol received the proper materials and instructions to safely enter patients into the study.
- Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements.
- Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitored data for missing or implausible data.
- Ensured the resources of the sponsor were spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy.
- Ensured audit readiness at the site level and traveled as required.
- Prepared accurate and timely trip reports and managed small projects under direction of a Project Manager/Director as assigned.
- Served as lead monitor for a protocol or project and assisted in establishing monitoring plans.
Clinical Research Associate II
Covance (acquired by Labcorp)
Princeton
03.2019 - 03.2020
- Previously responsible for all aspects of study site monitoring including routine monitoring and closed out visits, maintained study files, conducted pre-study and initiation visits; liaised with vendors; and other duties, as assigned.
- Previously responsible for all aspects of site management as described in the project plans.
- General on-site monitoring responsibilities were to ensure the study staff who will conduct the protocol received the proper materials and instructions to safely enter patients into the study.
- Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements.
- Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitored data for missing or implausible data.
- Ensured the resources of the sponsor were spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy.
- Ensured audit readiness at the site level and traveled as required.
- Prepared accurate and timely trip reports.
Clinical Research Associate I / II
PRA Health Services
Raleigh
02.2016 - 03.2019
- Implemented and monitored clinical trials to ensure sponsor and investigator obligations were met and compliant with applicable local regulatory requirements and ICH-GCP guidelines.
- Assessed the qualification of potential investigative sites, initiated clinical trials at investigator sites and instructed site personnel on the proper conduct of clinical trials and performed close out visits at sites.
- Reviewed and verified accuracy of clinical trial data collected either onsite or remotely.
- Provided regular site status information to team members, trial management and updated management tools.
- Completed monitoring activities and activity documents as required by PRA SOPs or other contractual obligations.
- Collaborated closely with other clinical team members to facilitate timely resolution of trial issues.
- Escalated site and trial related issues per PRA SOPs, until identified issues were resolved and closed.
- Performed essential document site file reconciliation.
- Performed source document verification and query resolution.
- Assessed IP accountability, dispensation, and compliance at the investigative sites.
Clinical Research Coordinator
Southern Cancer Center
Mobile
04.2012 - 02.2016
- Facilitated all implemented phases of new research studies as well as the coordination and maintenance of open and closed studies.
- Participated in identification of eligible patients for studies which included recruiting, screening, and enrolling participants in oncology protocols.
- Accurately documented clinical research data; was GCP, NIH and IATA certified.
- Identified trends in side effects and worked with the principal investigator to develop and evaluate patient management strategies.
- Collaborated with the PI, physicians and monitors to respond to any monitoring findings to implement corrective action plans.
- Assessed protocol-related needs and identified applicable resources, scheduled testing, and dispensed study medications.
- Obtained trial participant informed consent, oversaw all aspects of PSV and SIV monitoring visits and opened over fifty oncology clinical trials in four years.
Data Analyses and Abstraction
MedAssurant
Bowie
11.2010 - 02.2012
- Performed chart review and risk assessment while conducting medical record review and abstraction services.
- Completed quality, accuracy and inter-related reliability testing through documentation review.
- Performed data analysis and chart reviews to validate the integrity of previously presented insurance claims.
- Abstracted data to identify errors in billing and recognized practitioners in need of education regarding appropriate documentation standards.
- Identified practitioners that inappropriately filed claims and based on their documentation, provided corrections to the appropriate insurance company for adjustment.
- Performed chart reviews (HEDIS NCQA) to evaluate healthcare quality and applied performance measures that compared quality of care against a set of standards to determine performance reliability of managed care plans.
- Reviewed physician documentation to determine how they performed on different measures as designated by NCQA.
- Utilized the standards ICD-9-CM and ICD-10-CM to appropriately code conditions documented by physicians and corrected diseases/conditions that had been inappropriately coded by physicians.
Case Manager, Registered Nurse
Amidases Home Health
Mobile
02.2010 - 11.2010
- Participated in clinical outcomes monitoring, follow up and agency performance improvement initiatives.
- Coordinated an initial plan of care for patients based on patient assessment and physician orders.
- Evaluated and treated patients using the most current technology practices.
- Managed and educated Home Health Aides and LPN's.
- Managed a consistent case load and gained quality experience working on a multidisciplinary team.
Registered Nurse, Oncology/Med-Surgical
Thomas Hospital
Fairhope
06.2009 - 04.2010
- Dispensed medication and electronically charted patient details during the shift.
- Utilized critical thinking, acute assessment skills and self-sufficiency to coordinate with physicians on patient care and physicians' orders.
- Maintained the assessment, care, and safety of 6-7 patients per shift in a fast-paced, acute care inpatient setting.
Education
Bachelor of Science - Nursing
University of Mobile
Mobile, ALLanguage Capabilities
English
Other Experience
Experience in Electronic Data Capture Trials: BioClinica EDC, DataBasics, Medidata RAVE, INFORM
Certification
Registered Nurse
Oncology Treatment Types
- Chemotherapy
- Immunotherapy
- Hormone Therapy
- Targeted Therapy
- Vaccine Therapy
Therapeutic Experience
- NeuroScience: Pain - Other Pain - Post Surgical knee and shoulder nerve block (Phase II, III)
- Infectious Disease: Vaccines for bacterial or viral disease prevention (Phase I)
- Oncology: Solid Tumors - Breast (early breast cancer) (Phase I, II), Breast (Triple Negative Breast Cancer) (Phase I, II), Breast (HER2+) (Phase I, II), Breast (HR+) (Phase I, II), Gastro-intestinal Tumors - Colorectal (Phase I), Gastro-intestinal Tumors - Gastro-Esophageal Cancer (Phase I), Gastro-intestinal Tumors - Biliary Tract Cancer (Phase I), Gastro-intestinal Tumors - Pancreatic Cancer (Phase I), Gastro-intestinal Tumors - Rectal Cancer (Phase I), Genito-Urinary Tumors - Renal Cell Carcinoma (Phase I), Gynecological Tumors - Non Epithelial Ovarian Cancer (Phase I), Head and Neck - Squamous Cell Ca (Phase I), Head & Neck - Nasopharyngeal (Phase I), Melanoma (Metastatic) (Phase I, II), Sarcomas- Soft Tissue Sarcoma (Phase I), Sarcomas- Osteosarcoma (Phase I), Sarcomas- GIST (Gastro-Intestinal sarcoma) (Phase I), Thoracic Tumors -Small Cell Lung Cancer (Phase I, II), Thoracic Tumors -Non-Small Cell Lung Cancer (Phase I, II), Thoracic Tumors -Non-Small Cell Lung Cancer (Squamous Cell Carcinoma) (Phase I, II), Thoracic Tumors -Non-Small Cell Lung Cancer (Non-Squamous Cell Carcinoma) (Phase I, II); Hematologic Malignancies - Hodgkins Lymphoma (Phase I, II)
Timeline
Senior Clinical Research Associate III
IQVIA Drug Development
05.2023 - Current
Senior Clinical Research Associate II
Labcorp Drug Development
06.2022 - Current
Senior Clinical Research Associate
ICON Clinical Research
02.2021 - 06.2022
Senior Clinical Research Associate I
Covance (acquired by Labcorp)
03.2020 - 02.2021
Clinical Research Associate II
Covance (acquired by Labcorp)
03.2019 - 03.2020
Clinical Research Associate I / II
PRA Health Services
02.2016 - 03.2019
Clinical Research Coordinator
Southern Cancer Center
04.2012 - 02.2016
Data Analyses and Abstraction
MedAssurant
11.2010 - 02.2012
Case Manager, Registered Nurse
Amidases Home Health
02.2010 - 11.2010
Registered Nurse, Oncology/Med-Surgical
Thomas Hospital
06.2009 - 04.2010
Bachelor of Science - Nursing
University of Mobile