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Clinical Research Coordinator Resume Samples
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0-5 years of experience
Coordinated schedules of patients, therapists and doctors while adhering to strict protocol
guidelines.
- Executed and supervised 12 clinical research studies at a time, from recruitment of subjects to end of study.
- Recruited 6-8 patients for each clinical trial, exceeding the enrollment goals.
- Designed source documents for each clinical research study thereby optimizing the amount of correct data captured at each patient visit.
- Secured business relationships with advertising vendors and worked with them to utilize
- Advised Principal Investigator on decisions such as trial acquisition, advertising and patient interactions.
0-5 years of experience
Evaluated, scheduled, recruited, and enrolled 10-18 year old patients and families of a community based clinic into a national clinical trial on vitamin D and the benefits on the cardiovascular health system
- Effectively communicated with families, providers, and medical staff to efficiently coordinate study procedures set forth the by NIH protocol.
- Cooperated with other health related agencies and organizations in community activities.
- Assisted in the design an execution of programs that contributed to a 32% growth of the trial within 1 fiscal year.
0-5 years of experience
Assisted Medical Oncologists, Surgeons, and Nurse Case Managers in assessing patient eligibility
- Effectively met deadlines and consistently exceeded expectation for timely data collection and submission
- Evaluated needs of patients newly diagnosed with breast cancer and brain cancer to best serve as their advocate
- Oversaw adherence to study protocol for radiographic and clinical patient evaluations, treatment administration, and collection, processing, and shipping of biological specimens
- Maintained accurate records of Adverse Events, expedited reports of Serious Adverse Events, and conducted neurocognitive assessments and mental status exams throughout a patient’s treatment
- Collaborated with Pharmacists and Medical Oncologists to build and manage patient treatment plans
- Ensured accurate billing of study versus standard of care procedures and corrected charges when necessary
6-10 years of experience
Responsible for coordination of clinical research activities conducted within the Joint Penn-CHOP Center for Digestive, Liver and Pancreatic Medicine, whose mission is to help adolescents take the step from Pediatric care to Adult care, conducting research in the Center for Pediatric Inflammatory Bowel Disease.
- Coordinated, organized and maintained all study documentation including source documentation, case report forms, study and regulatory binders and patient binders.
- Screened subjects from the daily clinic schedule and confirm eligibility of potential study subjects.
- Recruited approximately 300 subjects for various studies and administered informed consent.
- Scheduled study visits and necessary testing including procuring blood, urine, serum, and intestinal specimens.
- Prepared and processed all documentation through the Institutional Review Board (IRB), including submissions, continuing reviews, amendments and adverse event reporting.
- Prepared for and participated in audits conducted by sponsors and other oversight entities such as CHOP’s Regulatory and Compliance Office.
0-5 years of experience
Worked with and under the Principal Investigator; supported, facilitated, and coordinated the daily clinical trial activities. Independently handled large caseloads (30-50) of patients, collected data as required by protocols.
ACHIEVEMENTS:
- Maintained effective/ongoing communication with research participants/sponsors increasing customer satisfaction
- Coordinated appropriate and timely payments to participants ensuring sustained enrollments
- Implemented approved recommendations for audit findings reducing repeat discrepancies
- Great problem-solving, and analytical skills were possessed to maintain job with ease
0-5 years of experience
Maintained IRB annual renewals and refined research protocols; acted as a liaison with physician and drug companies
- Prepare and participate in conducting patient and study visits
- Managed regulatory documents and clinical trial manuals; designed patient tracking charts using spreadsheets and formulated source documents and data collection charts
- Facilitated completion of clinical charts and case report forms. Controlled quality of data retrieved from patient records and reported research activities to team.
- Knowledge of ICH and local regulatory authority regulations regarding drug research and development
0-5 years of experience
Operated as a certified clinical research coordinator under the direction of the principal investigator in a private urology practice involved in phase 1 through phase 4 pharmaceutical studies, including prostate cancer, over active bladder, incontinence, SPV virus, sperm testing, sexual dysfunctions
- Coordinated all phases of clinical trials study start up to study closure; acted as liaison between the physician and sponsor
- Managed regulatory documents and clinical trials manuals; designed patient tracking charts using spreadsheets and formulated source documents and data collection charts
- Facilitated the completion of clinical charts and case report forms
- Controlled quality of data retrieved from hospital records and reported research activities to team
- Wrote severe adverse event reports and obtained MD signatures; submitted to sponsor and the IRB
- Implemented recruitment strategies to get PI’s more involved with subject enrollment
- Identified problems and/ or inconsistencies and monitor patients’ progress to include documentation and reporting of adverse events
0-5 years of experience
Ensured compliance with protocol guidelines and requirements of regulatory agencies; identified problems and/or inconsistencies and monitor patients’ progress to include documentation and reporting of adverse events in the areas of neurology, sleep medicine, and pulmonology.
- Facilitated regulatory management using FDA and USDA requirements. IRB reporting.
- Conducted patient visits. Knowledge and utilization of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Hazard Analysis Critical Control Points (HACCP).
- Collected data, analyzed, and communicated the results of biological studies.
- Developed forms, questionnaires and the application of research techniques; collaborate in writing of investigator-initiated protocols, and source documents for data collection.
- Assisted investigator with protocol development and staff training on protocols and proper procedures.
0-5 years of experience
US Oncology research network
- Clinical coordination of numerous Phase II and Phase III studies for solid and hematologic diseases.
- Demonstrated ability, efficiency and flexibility in working at 5 different clinic sites as needed to meet research department and staffing needs.
- Responsible for assisting in the informed consent process, screening potential patients for adult oncology clinical trials; assessed treatment patients for toxicities, dose modifications, and serious adverse events.
- Provided patient/family/medical/nursing staff education related to clinical trials; assisted physicians in tumor assessments of subjects as per protocol.
- Assisted in accurate data collection, ordered all protocol requirements and obtained results; performed ECG’s; prepared, handled and shipped all required research specimens.
- Attended research/clinic meetings and trainings bi-monthly or more as needed and required.
0-5 years of experience
Acted as project manager for 3 clinical trials simultaneously.
- Managed all day-to-day activities necessary to facilitate the successful completion of each trial.
- Developed and executed plan to ensure that all aspects of each study were completed with strict adherence to protocol.
- Trained 9 clinic personnel to effectively complete study specific procedures and documentation.
- Evaluated and analyzed clinical research data to ensure accuracy and consistency between source documents as well as proper, timely reporting of critical study events.
- Assisted in preparation for United States Food and Drug Administration and Institutional Review Board audits.
- Responsible for identifying 3 clinical protocols and implementing them as project lead.
- Designed and implemented recruitment strategies that earned company the title of highest national subject enrollment with 150 subjects for a HIV clinical trial.
0-5 years of experience
3400 Spruce St., Gates Bldg, 10th Flr, Philadelphia, PA 19104
- Clinical Research Coordinator
- Multi-modal study integrating psychosocial, neuropsychological, neuroimaging, and genomics research to identify predictive biomarkers in prodromal/preonset psychosis
- Conducted semi-structured and structured clinical interviews and computerized neurocognitive battery (CNB) with research participants
- Wrote and prepared summaries of impressions to be presented at case conference where prodromal status is determined by consensus
0-5 years of experience
Responsible for clinical decision-making and regular communication with study subjects and Principal Investigator
- Assessed clinical performance and ergonomics of devices; provided feedback to multidisciplinary R&D team
- Maintained detailed logs regarding history of subject participation, employee trainings, device components, etc.
- Assisted in the development of fail-safe features for new device mechanisms to ensure subject safety
- Designed procedures for device validation testing including optical, mechanical, electrical, and software
- Data collection and troubleshooting using various equipment (National Instruments, Thorlabs, Yokogawa, etc.)
- Assembly and verification of electrical components (prototype breakout boards, cable fabrication, soldering, etc.)
0-5 years of experience
Collaborate with investigators and sponsoring organizations to conduct all aspects of clinical trials
- Recruited, screened, enrolled, and scheduled study subjects
- Collected information, recorded all data, completed case report form, and reported SAEs
- Obtained informed consent, performed assessments, and trained by Canfield medical photography
- GCP and HIPPA trained, SIVs, interaction and submission to the IRB, study close outs
- Performed blood draws, specimen shipments, ECGs, vital signs, and ultrasound
- Attended Investigator Meetings around the US and assigned as Lead Coordinator for clinical trials
0-5 years of experience
CRC for 7 studies; high enroller for 5 of the 7 studies,
- Worked in a fast paced environment, able to meet deadlines for each database lock
- Created source documents for studies, performed laboratory processing
- Conducted and participated in protocol meetings with multidisciplinary staff in attendance
- Instructed new hires on protocols and on ICH/GCP guidelines
- Involved in a FDA audit and 2 sponsor audits
- Interfaced with Sponsors and Monitors
0-5 years of experience
Oversaw all phases of clinical trials which focused on African Americans and minorities and other urological diseases and conditions
- Educated community, physicians, and patient care support staff on protocol specifics of clinical trials
- Managed the community and personal schedules of urologists
- Served as an liaison with physician and pharmaceutical companies for contract and budget negotiations
- Credited with coordinating successful health fairs in the Metropolitan Atlanta area with over 1500 participants
- Facilitated monthly support groups for urological conditions and diseases
- Managed regulatory documents and clinical trials manuals
6-10 years of experience
Performed all aspects of project management including subject eligibility, data collection, protocol compliance
- Assisted physician with all procedures including Physicals, Pap Smears, Endometrial Bxs and Colposcopies
- Performed lab and specimen submissions
- Created and redesigned source docs and maintained accurate and complete research files
- Attended all Investigator Meetings and trainings
- Performed regulatory submissions, have working knowledge of CFR, GCP and ICH
0-5 years of experience
Submitted start up documents as well as maintained regulatory binders
- Assisted with budget negotiations and implemented process changes necessary to accommodate new protocols.
- Scheduled patients and performed patient visits according to protocols and GCP.
- Performed blood draws, ECG’s, and processed blood and urine according to protocol.
- Entered eCRFs and answered all queries timely.
- Worked closely with the PI in selection of potential studies and review of ongoing studies.
0-5 years of experience
Responsible for enrollment and retention of study subjects
- Obtained informed consent and medical history
- Conducted enrollment procedures: Venipuncture, ECG’s, Pulmonary Function Tests, vital signs
- Collected and processed specimens for laboratory evaluation
- Managed serious adverse event reporting to sponsor and ethics committee
- Prepared and presented in-services to physicians and study staff
- Certified Clinical Research Coordinator (CCRC) – March 2012
0-5 years of experience
Coordinated phase I – IV breast oncology trials (18 active and 7 follow up studies)
- Worked with monitors during site initiation visits
- Attended investigator meetings
- Screened patients in clinic,
- Performed all required protocol specific procedures, including preparing lab specimens for shipments, shipping labs, data management and preparing for monitor visits.
- Maintained professional communication with all sponsors Initiated monthly meetings with investigators to review protocols and research patients
- Managed regulatory, including SAE submissions, advertisement reviews and safety report reviews
0-5 years of experience
Maintained current study progress records and enter clinical data into clinical tracking system.
- Communicated deviations in study conduct to study team and management.
- Monitored performance metrics for the trial, observes and reports trends.
- Facilitated the internal audit plan and process for the trial, ensure adherence to Good Medical
- Ensured required clinical trial documents (i.e. CV’s, lab certifications, financial disclosures, etc.)
- Assisted with vendor set up and management and assisted in tracking investigational product,
- Performed site co-monitoring in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
- Carried out 40-50% travel to sites.
0-5 years of experience
Responsibilities – Implementation and continuation of research studies as contracted through various pharmaceutical companies
- Responsible for traveling to conferences in the US for research studies
- Recruited and scheduled patients for studies, completed patient questionnaires and collected additional study data on routine basis; dispensed medications and monitored patients for adverse effects
- Recorded findings through the use of various medical charting software and compiled reports on outcomes of studies for study sponsors
- Performed Remicade and Iron IV infusions, administered injections, performed
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Clinical Research Coordinator
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
