Clinical Research Coordinator
Resume:
Hiba Butt
Hamilton, NJ *****
**.********@*****.***
Clinical Research Coordinator with extensive experience in NIH-funded studies, Sponsor/CRO, i.e, BMS, Merck, Amgen, ICON, Beigene, JNJ, AstraZeneca. Studies IRB processes, multisite collaboration, and protocol implementation. Demonstrated ability to manage patient recruitment, data collection, and regulatory compliance across oncology studies.. Skilled at coordinating with Principal Investigators, research staff, and sponsors to ensure timely and ethical execution of study protocols. Committed to advancing clinical science while maintaining patient safety and research integrity.
In my current roles, I have demonstrated exceptional project management skills by simultaneously overseeing multiple clinical trials (Phase I through Phase III) while ensuring adherence to strict timelines. I manage medical information inquiries into medical information databases, tracking systems, and project-specific forms, ensuring accurate data entry in accordance with the ALCOA guidelines. I possess experience in statistical analysis, developing meaningful insights from complex datasets and presenting findings to stakeholders in clear and concise reports. I compile case safety reports and technical product complaints, forwarding them to relevant stakeholders within established timelines. I am a passionate advocate for patient safety and ethical research practices, with a proven track record in navigating complex regulatory environments and ensuring that compliance with all guidelines and standards is maintained. I monitor and interpret global regulations pertaining to medical information and pharmacovigilance, providing regulatory expertise to colleagues and clients.
PROFESSIONAL SKILLS SUMMARY
Clinical Trial Design & Execution Leadership & Team Building Data Analysis & Interpretation
Good Clinical Practice (GCP) Guidelines, Disease States / Therapeutic Areas, Regulatory Compliance
Laboratory Safety Good Laboratory Practice (GLP) Hazard Analysis (HACCP)
ICH Guidelines IRB Approval Process Clinical Trial Protocols
SAE Reporting Pharmacovigilance Audits / Inspections
PROFESIONAL EXPERIENCE
Clinical Research Coordinator (LUNG/HEAD N Neck)
Rutgers-Cancer Institute Of New Jersey 01/02/2024 - Present
Coordinate NIH-funded and multisite studies, Sponsors/CRO studies in collaboration with Principal Investigators, including protocol start-up, Study activation, regulatory approvals, participant recruitment, informed consent, and clinical assessments. Ensure proper documentation in OnCore® and compliance with IRB and GCP standards. Site Management skills: Conduct site selection, initiation, monitoring, and closeout visits to ensure compliance with study protocols and regulatory standards. Act as the primary liaison between study sites, vendors, and the internal study team.
Serve as a focal point for establishing protocol, workflows, and processes to support high-quality clinical research activities for the implementation and conduct of clinical trials. Supervise day-to-day clinical research coordination operations, performing regular audits of the assigned team to ensure data collected is complete and accurate and project, data collection, and protocol carried out aligned to standards. Coordinate the recruitment and screening of study participants. Manage Medical monitoring visits and maintain relationships with industry partners and funding agencies. Collaborate with other researchers and healthcare professionals to achieve advances in healthcare treatment.
Collaborate with physicians to assess patient eligibility for clinical trials.
Review medical records and obtain necessary source documents to confirm protocol eligibility.
Facilitate the informed consent process, ensuring patients understand the study and its implications.
Utilize the OnCore® Clinical Trials Management System to register patients and manage study data.
Maintain accurate documentation within the Trial Master File, ensuring readiness for audits and regulatory inspections.
Coordinate clinical assessments and patient care activities in collaboration with ancillary departments such as pathology, radiology, and infusion services.
Monitor patient progress, manage adverse events, and ensure adherence to protocol requirements.
Ensure all clinical trial activities comply with Institutional Review Board (IRB) guidelines and federal regulations.
Report serious and unexpected adverse events promptly, maintaining transparency and patient safety.
Participate in multidisciplinary meetings to discuss patient care and trial progress.
Serve as a liaison between patients, investigators, and the broader clinical research team.
ACHIEVEMENTS
Boosted study enrollment by proactively engaging patients—explaining complex informed-consent protocols in detail, encouraging questions, and ensuring clear understanding.
Supported Medical Monitor in safety oversight, trending, and reviewing study-specific safety data (adverse events, vitals, ECGs, lab results) to ensure timely reporting and data integrity. Priortizing Database Lock time point, Interim Analysis safety reports.
Led adverse-event investigation initiatives, analyzing AEs, SAEs, and special-interest events; actively participated in Safety Management Team meetings alongside the Pharmacovigilance Lead to identify safety signals and recommend protocol adjustments.
Research Study Assistant 03/2021-01/02/2024
Rutgers-Cancer Institute Of New Jersey
(Phase I/II/III Breast Cancer, Genitourinary-Prostate Cancer, Renal Cell Carcinoma, Endometrial Carcinomas, Ovarian tumors, and Germ Cell Tumors)
•Working as a research Study assistant under the supervision of the research coordinator and data manager on the electronic data capture plan i.e. iMedidata RAVE, INFORM, ADVARA, OnCore, RedCap and J- Review reporting system for Safety reporting
•Review CT, MRI, BIOPSY, and Surgical Pathology report.
•Disease Assessment as per RECIST 1.1 criteria
•Review Disease Response i.e. Stable Disease, Partial response, Complete response, or Progression of Disease as per NADIR calculation
•Documentation of adverse events, SAEs, SUSAR related/Unrelated to the investigational product.
•Review protocol and non-protocol therapies.
•Look for drug pharmacokinetics, research-related lab collections
ACHIEVEMENT
Brought data documentation for breast studies from 65% incomplete to 95% complete within the first three months of tenure by following Study protocols and ICH and GCP guidelines, receiving acknowledgement of success by the Director.
Minimal Audit findings in EDC.
Delivering Quality data
Completing data entry in timely manner to adhere in compliance with Database lock, Interim analysis.
Resolving queries and uploading images to the imaging portals like Clario, Calyx, AG Mednet, TRIAd
Research Program Coordinator 12/2018-3/2021
Mercer County Community College West Windsor, NJ
Oversaw, developed, and managed research programs and initiatives, including budgeting, scheduling, and resource allocations. Developed curricula, reviewed and revised course materials, and developed teaching strategies to ensure quality learning experiences. Provided guidance and support to students participating in research programs, including development of research proposals. Collaborated with faculty members to identify research opportunities and establish partnerships with external organizations. Ensured all research programs conducted in compliance with ethical and regulatory guidelines. Oversaw data collection, analysis, and dissemination.
Achievements
Improved student awareness of career opportunities in clinical research by one-on-one counseling and guidance on course selection.
Expanded student knowledge of Medical terminologies, resulting in high grades in passing classes.
Taught medical and research courses such as Anatomy, Physiology, Biochemistry, Pharmacology, Fundamentals of Clinical Research, and Regulatory Affairs, including role of CRC, CRA, IRBS, sponsors, investigators, site selection, and site initiation visits.
Clinical Research Physician 04/2015-11/2018
Developed and oversaw multiple clinical research studies, collaborating with research team to design and develop study protocols adhering to SOPs, regulatory guidelines, and best practices. Directed the recruitment and management of study participants, including establishing protocols and informed consent, gathering data from patient charts, tabulating research data, recording results, preparing research manuscripts and presentations, and developing and maintaining research databases. Monitored study participant safety and ensured adverse events reported in timely and appropriate manner. Ensured all aspects of study adhered to regulatory guidelines and requirements
ACHIEVEMENTS
Successfully led the preparation and proper completion of clinical trials prior to IRB submission and coordinated multiple clinical research studies within the School of Medicine.
House Officer (RESIDENCY) 03/2014-03/2015
Provided patient care under the supervision of experienced medical professionals, diagnosing, treating, and discharging inpatients and outpatients of Internal Medicine, Emergency Medicine, Family Medicine, Obstetrics and Gynecology, and General Surgery. Performed surgical procedures, including cholecystectomy, appendectomy, and exploratory laparotomy. Documented patient care in medical records and communicated with other members of healthcare staff. Adhered to all hospital policies, procedures, and regulations, including those related to patient confidentiality and safety. Contributed to the supervision of clinical education of medical students. Conducted patient rounds, monitoring medication, progress, and recovery.
EDUCATION AND CREDENTIALS
Doctor of Medicine Liaquat University of Medical & Health Sciences Jamsboro, Pakistan 2014
Certified in Clinical Development and Regulatory Affairs Mercer County Community College West Windsor, NJ 2018
COMMUNITY INVOLVEMENT
Research Intern Polio Vaccination Campaign Hyderabad, Pakistan 1/2012 – 2/2014
TECHNICAL SKILLS
Essential Software Rave, Medidata, Inform, OnCore, Redcap, ADVARA, J- Review system for safety reporting
Additional Tools Microsoft Office Suite, Microsoft Teams, Microsoft Word, Microsoft Excel, SharePoint, Electronic Data Capture (EDC), Electronic Trial Master File (eTMF)
Contact this candidate