Karla Khan
La Habra
Summary
Dynamic Sr. Clinical Research Associate I at Fortrea, skilled in site monitoring and regulatory compliance. Proven ability to enhance team performance through effective training and leadership. Recognized for meticulous attention to detail, ensuring data integrity and patient safety in clinical trials. Committed to driving successful outcomes in diverse therapeutic areas.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Sr. Clinical Research Associate I
Fortrea( formerly Labcorp)
Durham
10.2021 - Current
- Responsible for all aspects of study site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaising with vendors, and other duties as assigned.
- Responsible for all aspects of site management, as prescribed in the project plans.
- Ensure the study staff who will conduct the protocol have received the proper materials, training, and instructions to safely conduct 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.
- Assist with the training, mentoring, and development of new employees, e.g. Trained other CRAs in how to use systems such as Veeva and CTMs , Co-monitoring
- Ensure the resources of the sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines.
- Ensure audit readiness at the site level.
- Prepare accurate and timely trip reports.
- Maintain accurate documentation of all on-site activities in the trial master file.
- Evaluate proof of eligibility and consent for participants.
- Coordinate the shipment of investigational drugs to sites.
- Assist with budget/invoicing during close-out activities.
- Assist the regulatory start-up team in preparing the sites for selection and activation
- Assisted the CTL in ICF translation submission
Study Coordinator
UCI Chao Family Comprehensive Cancer
Orange
12.2017 - 10.2021
- Coordinated basket trials that would incorporate different diseases such as: melanoma, breast cancer, lung cancer and colon cancer
- Conducted all the screening activities for the subject and reviewed eligibility with the PI
- Ordered blood work, reviewed concomitant medications, performed EKGs, distributed study drug and reviewed adverse events
- Prepared studies for sponsor audits and study closures
- Submitted PRMC and IRB applications for new studies
- Coordinated all study assessments for Phase I to Phase III studies
- Reviewed thoroughly all subject’s charts to verify, fix and update any information
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Patient Care Coordinator
Crystal Coast Pain Management
New Bern
01.2017 - 10.2017
- Processed a North Carolina Controlled Substance Report for potential patients
- Worked on a Physician Quality Reporting System (PQRS) project alongside management
- Trained new employees and reported back to management
- Communicated with patients to ensure quality of care and develop care plans.
- Screened patients for eligibility for state, local and federal assistance programs.
Data Manager
UCLA Jonsson Comprehensive Cancer Center
Los Angeles
07.2016 - 12.2016
- Prepared for FDA audit
- Followed the site’s standard operating procedures
- knowledge/training of Good Clinical Practices
- Entered all required data and answered all queries in a timely manner
- Attended Site Initiation Visit meetings
- Monitored patient safety during clinical trials according to established guidelines.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Prepared informed consent forms for review by ethics committees.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel throughout the life cycle of the trial.
Administrative Assistant
UCLA Jonsson Comprehensive Cancer Center
Los Angeles
02.2015 - 07.2016
- Responsible for providing all chemotherapy patients with their treatment schedule
- Learned medical terminology specific to Oncology
- Handled confidential documents in an organized fashion according to established protocol.
- Answered phone calls and emails to provide information, resulting in effective business correspondence.
- Organized files, developed spreadsheets, faxed reports and scanned documents, maintaining front desk and reception area in neat and organized fashion.
Community Health Representative
Perez-Pacheco Consulting Inc.
Los Angeles
11.2014 - 02.2015
- Worked with local clinics to provide free vaccines and physical exams to under-served populations
- Responsible for presentations on oral hygiene, blood pressure, cholesterol, healthcare plans and nutrition
- Organized meetings between healthcare providers and community members to discuss health concerns.
- Coordinated wellness activities such as screenings, vaccinations, blood pressure checks.
Education
Bachelor of Science - Environmental Studies - Emphasis on Chemistry
University of California-Santa Barbara
Santa Barbara, CA, USASkills
- ICH-gCP guidelines
- Site monitoring expertise
- Regulatory compliance
- Vendor management
- Attention to detail
- Therapeutic area expertise
- Teamwork
- Adaptability
- Leadership
Therapeutic Experience
Oncology: Solid Tumors – Breast (Phase I, II, III), Endocrine Tumors – Thyroid Cancer (Phase I, II, III), Gastro-intestinal Tumors – Colorectal (Phase I, II, III), Gastro-intestinal Tumors – Hepatocellular/liver (Phase I, II), Head and Neck – Squamous Cell Ca (Phase I, II, III), Melanoma (Loco-regional) (Phase I), Melanoma (Metastatic) (Phase I, II, III), Melanoma (PD-L1 expression) (Phase I), Thoracic Tumors -Non-Small Cell Lung Cancer (Phase I, II, III); Hematologic Malignancies – DLBCL (Phase I, II), non-Hodgkins Lymphoma (Phase I-II)
Systems Experience
Microsoft Office (Excel, Outlook, Word, PowerPoint), Medidata Rave EDC,Bioclinica, Oracle Inform, Advarra, ALMAC
IRT Signant Health,Shared Investigator Portal, CTMS, VEEVA, Xcellerate RIM, Lablink, Acolad,Vestigo, Complion, Florence
Certification
- Society of Clinical Research Associates- Certified Clinical Research Professional (CCRP)
Languages
English
Native/ Bilingual
Spanish
Native/ Bilingual
Timeline
Sr. Clinical Research Associate I
Fortrea( formerly Labcorp)
10.2021 - Current
Study Coordinator
UCI Chao Family Comprehensive Cancer
12.2017 - 10.2021
Patient Care Coordinator
Crystal Coast Pain Management
01.2017 - 10.2017
Data Manager
UCLA Jonsson Comprehensive Cancer Center
07.2016 - 12.2016
Administrative Assistant
UCLA Jonsson Comprehensive Cancer Center
02.2015 - 07.2016
Community Health Representative
Perez-Pacheco Consulting Inc.
11.2014 - 02.2015
Bachelor of Science - Environmental Studies - Emphasis on Chemistry
University of California-Santa Barbara
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