Clinical Research Coordinator resume examples

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Skillful Clinical Research Coordinator resume

MELISSA LYNN
Summary
10 years of nursing experience in broad range of specialties. Recognized by peers as a strong team player and patient advocate; providing the highest standards of excellence, best practices and superior customer service.
Skills

Detailed oriented, work well autonomously and in team settings, EPIC, OnCore, MCG, Interqual, Acuity, Amisys, EXP, Word, Power Point, EXP Macess, Visio, GoToMeeting, GoToWebinar, telephonic case management, inpatient Case management, clinical auditing, knowledge of NCQA and CMS compliance standards, outpatient oncology, public health, pediatrics, vaccines, ICU, Intracranial Pressure Monitoring, Arterial Lines, intravenous drips, chest tube care, Halo traction, ET tube care/suctioning, continuous bladder irrigation

Experience
University of Florida 2000 SW Archer Rd, RM 2125 Gainesville, FL 32610 Clinical Research Coordinator 02/2018 to Current
  • Collect data from medical records
  • Maintain patient protocol records
  • Submit data to sponsors in a timely manner
  • Collaborate with monitors and/or sponsors' data management units
  • Collaborate with internal and external IRB staff
  • Identify potential protocol candidates and confirm patient eligibility
  • Register or randomize patients with appropriate sponsors
  • Provide education related to informed consent
  • Follow patient hospitalizations, clinic/office visits, treatments and scheduled activities
  • Order protocol tests and communicate test results with patients and families
  • Act as a resource for clinical staff in the administration and toxicity assessment of protocol regimens
  • Act as liaison for institutions with clinical trial sponsors, NCI and data managers involved with protocols
  • Obtain, process and ship clinical samples according to sponsor requirements
AVMED Gainesville, FL Clinical Educator 11/2015 to 12/2017
  • Back up for department Manager: time off approval and time sheet submissions
  • Responsible for medical staff orientation and annual employee competency through a variety of assessment and training techniques
  • Experience with training staff in person and via Lync, video conference, GoToWebinar and GoToMeetings
  • Created Visio workflows to highlight departmental processes
  • Performed chart audits to ensure staff were meeting both NCQA and CMS compliance standards
  • Assisted with preparation for NCQA and CMS audits
  • Assisted department Managers and Directors with projects as needed
  • Project Manager for annual upgrade of MCG and CWQI
  • Company Administrator for MCG
Case Manager 03/2015 to 11/2015
  • Served as case manager for high risk maternity and complex patients by performing assessments, forming care plans and collaborating with other medical professionals.
  • Coordinated home health, home infusion and DME.
  • Assisted with streamlining and organizing the Maternity Case Management workflow.
Care Transitions Coach 11/2014 to 03/2015
  • Placed calls to Medicare and Commercial members on days 1,7,15 and 30 post discharge to ensure all needs were met, all problems solved and to provide education to members.
  • Department Preceptor for incoming clinical staff.
Inpatient Case Manager 07/2012 to 11/2014
  • Performed electronic medical record and faxed paper chart review for medical necessity.
  • MCG and Acuity experience.
  • Worked closely with the interdisciplinary team to arrange the next level of care to prevent delays in care.
  • Participated in daily rounds with Supervisor and Medical Director to discuss cases.
  • Department preceptor for incoming clinical staff.
NORTH FLORIDA REGIONAL MEDICAL CENTER Gainesville, FL Inpatient Case Manager 08/2011 to 07/2012
  • Performed utilization and concurrent review of inpatient cases using Interqual criteria.
  • Average case load 30 patients and was often able to assist other units.
  • Worked closely with the medical team to prevent delays in care.
  • Collaborated with patients and families at the bedside regarding discharge plans.
  • Arranged alternative care services; contact and maintain communication with insurance companies, long term care facilities, acute inpatient rehabilitation hospitals, skilled nursing facilities and home health care companies.
STATE OF FLORIDA Trenton, FL Registered Nurse Specialist 02/2010 to 08/2011
  • Provided general medical care and treatment to a population of pregnant women, new mothers, newborn babies, children up to the age of 18.
  • Provided contraceptive care and treatment of clients in Family Health, to include Women's Health and Sexually Transmitted Disease clinics.
  • Educated clients about vaccines, their benefits, side effects, and complications.
  • Assessed immunization statuses, administered vaccines/immunizations.
  • Investigated and reported communicable diseases to the state.
  • Assisted with Family Planning, Immunization, Breast & Cervical Cancer Control, and Tuberculosis clinics.
  • Triaged telephone calls from patients related to communicable disease, Pediatric illness and women's health.
UF HEALTH SHANDS HOSPITAL Gainesville, FL Oncology Clinic Care Coordinator/ ICU Nurse 01/2008 to 02/2010
  • Provided case management and care coordination for Gastrointestinal Oncology patients
  • Assisted the head of Oncology develop/organize a pilot program for GI Oncology where patients were evaluated by a multiple disciplinary team (Medical Oncology, Surgery and Radiation Oncology) all in the same day
  • PICC Line and Port flushes
  • PICC line and Port blood draws
  • Neurosurgical Performed a comprehensive range of clinical functions within the 30 bed Neurosurgical Intensive Care Unit
  • Provided direct patient care to those with aneurysms, head trauma, stroke, spinal cord injuries, brain tumors, epilepsy and more
  • Assessed patients needs, administered medications, assisted with bedside procedures, responded to emergencies
Education and Training
Associate of Science: Registered Nurse North Florida Community College, Madison, FL
Certified Nursing Assistant Professional Health Training Academy, Ocala, Fl
High School Diploma Lake Weir High School, Ocala, Fl, United States
CERTIFICATIONS AND LICENSES
  • 2008-2018 Registered Nurse License License No. RN9272946
  • 2016-2021 Certified Case Manager (CCM) Certificate No. 4221946
  • 2019-2023 Oncology Certified Nurse (OCN)
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Job-winning Clinical Research Coordinator resume

Ann McAdams-Jakuboski
Professional Summary

Hardworking nursing professional bringing 30+ years of experience delivering exceptional care to surgical and medical patients.


 Skilled at working independently and also collaboratively with the multi-disciplinary team.

Skills
  • Patient education and advocacy
  • Proficient EMR
  • Quality assurance
  • Patient consultation
Work History
Registered Nurse/Staff Nurse, 06/2014 to Current
Dattoli Cancer Center Sarasota, FL
  • Effective counseling in health maintenance and disease management of prostate cancer.
  • Liaised between patients and physicians to ensure patient comprehension of treatment plans.
  • Documented patient information obtained from interviews.
  • Ensured efficacy of treatments through monitoring of treatment regimens.
Nurse Manager, 07/2013 to 06/2014
Hillstrom Facial Plastic Surgery Bradenton, FL
  • Supervised clinical staff
  •  Purchasing supplies and monitoring Surgical budget to ensure financial objectives were met.
  • Ensured compliance with state and federal regulation 
  • Provided aesthetic consultations, preoperative and postoperative teaching.
  •  Coordination of surgery schedule with surgeons and ancillary staff in the ambulatory surgical setting 
  • Circulating and scrub for facial plastic procedures.
Clinical Research Coordinator, 10/2012 to 06/2013
Meridian Research Bradenton, Florida
  • responsible for the coordination of the clinical trials Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
  • Participate in the development of study protocols including guidelines for administration or data collection procedures.
  • Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
  • Knowledge of EMR system Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with primary investigator.
Perioperative Nurse/Office Nurse, 07/1998 to 07/2012
James Marsh, M.D Sarasota, Florida
  • Assist with plastic surgery procedures.
  • Responsible for patient sedation and recovery from surgery.
  • Administer preoperative and postoperative care.
  • Front office management skills Organized OSHA program Responsible for obtaining and maintaining AAAAFS accreditation.
  • Management of inventory and ordering medical supplies Provided consultations and assisted in marketing of practice.
Surgical Nurse, 01/1996 to 01/1998
Indianapolis, Indiana
  • Circulation and scrub duties for outpatient surgical center including Orthopedic, Urology, OB/GYN.
Private Scrub Nurse/ First Assistant, 01/1993 to 01/1995
Michael D. Levine M.D Bradenton, FL
  • Private scrub nurse assisting on plastic, reconstructive and upper extremity surgery.
  • Surgery scheduling
  •  Preauthorization of workman's compensation
  •  Communicate with injured employees, medical professionals, claims staff and employers.
  • Assess injury, functional abilities and physical job requirements to establish target return to work plans.
  • Facilitate appropriate return to work release and coordinate return to work efforts with all parties.
Surgical Nurse / First Surgery Assistant, 01/1989 to 01/1991
Indianapolis Plastic Surgeon Inc Bradenton, FL
  • Indianapolis, Indiana.
  • Scheduled surgery, pre and post operative care of patients.
  • Assisted in obtaining medical approval and pre-certification.
  • Specialized in General, Facial Plastic Surgery and Breast 
Education
Bachelor of Science: Nursing, 1983
University of Indianapolis
Personal Information
Licenses State of Florida Registered Nurse # 1910942 BLS and ACLS certifications.
Additional Information
  •  BLS  and ACLS certifications.
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Experienced Clinical Research Coordinator resume

MICHAEL OKECHUKWU
Professional Profile
A CRA with study monitoring experiences; Phases I-IV, ensuring data quality in accord with ALCOA-C, protects the rights and wellbeing of subjects, and follows protocol, SOP's, ICH/GCP, FDA and required regulatory guidelines.
Therapeutic Experiences
CNS- Alzheimer's, Schizophrenia 
Oncology- Breast & Lung
​Nephrology- Renal
Cardiovascular - Congestive Cardiac failure, Myocardial Infarction
Infectious Disease - Hepatitis B, C, HIV
Relevant Professional Skills
  • EDC Proficient: Medidata Rave, Oracle, Inform  
  • Serious Adverse Event (SAE)
  • Sponsor & Site interface to ensure timelines and deadlines are met
  • TMF: Intralinksvia  
  • Reporting Project development
  • Excellent interpersonal and communication skills
  • Data management CRF's & TMF's
  • Recruitment and screening
  • Project management
  • Detailed documentation
  • Ethics in Clinical Research, ICH, GCP, IATA
  • Health Insurance Portability & Accountability Act (HIPAA)
  • Microsoft Office Proficiency
  • Work with ICF
  • Certifications: ICH, GCP, IATA
  • Patient & Investigational Product Randomization.
  • Interactive Voice Response Converstant
  • Initiation and Close-out visit supervision
  • Proficient in MicrosoftOffice:Word, Excel, PowerPoint, Access, Outlook
  • Clinical Data: EMR (EPIC), EDC (Inform, Medidata Rave, and Oracle)
  • CTMS (IMPACT and LOTUS).
  • Proficient in Pages, Keynote and Numbers
Professional Experience
Clinical Research Associate
July 2017 to Current
Breakthrough Clinical Trials San Bernardino, CA
  • Perform site monitoring preparations, managements  and internal audits.
  • Prepare and review subject ICF
  • ICF preparation and submission for IRB approval
  • Ensure necessary translations are done
  • Ensure compliance with protocol and trial objective
  • Train site personnel 
  • Prepare for audits and administrative meetings
  • Preparation of regulatory documents, SOP's and Protocol submission
  • Strong understanding of ICH & GCP compliance
  • Collect and organize data.
  • Data cleaning
  • Perform other trial related activities, coordinate payments
  • Carry out site Close-out visits
  • Protocol adherence to ensure subject safety
  • Prepare training Material
  • Prepare and provide status report on assigned studies 
  • Proffer contingency planning recommendations
  • Data verification on CRF's and source (SDV)
Clinical Research Coordinator
August 2016 to July 2017
Breakthrough Clinical Trials San Bernardino, CA
  • Screen and recruit subjects based on protocol inclusion and exclusion criteria.
  • Ensure compliance with protocol and trial objective.
  • Collect and organize data.
  • Proficient knowledge of GCP, ICH &FDA regulations and SOP's 
  • Recruit, obtain informed consent, screen and enroll research subjects in studies/clinical trials
  • Review of subject Medical History against inclusion and exclusion criteria of study protocol.
  • Schedule patient visits according to protocol.
  • Performs patient visit reminders,  send out visit Confirmations and/or rescheduling of Visits if need be.
  • Meet with patient research subjects and perform visit requirements
  • Assess vital signs, collect specimen samples and perform phlebotomy and process  for shipment.
  • Immediate collection of all data pertaining to patient visits and upload to EDC or as stipulated by protocol.
  • Address all  monitoring visit related questions and facilitate the monitoring visit.
  • Resolve queries as soon as possible, possibly while the Monitor is on site.
  • Ensure the collection and updating of required documentation, signatures for Principal Investigator and other sub P.I's and, or study staff.
  • Communicate with Sponsor/CRO; obtain required documents Coordinate all Investigator Meetings.
  • Receiving supplies, review inventory, review new study Protocol for feasibility, capability, logistics, personnel needs.
  • Getting information and advertisements out in community and into Principal Investigator's practice(s).
  • Request patient medical records from ER, hospitals, other physicians.
  • Update and ensure that all device and/or drug accountability is current
  • Work on other projects as directed by the Site Director
Quality Assurance Specialist
August 2015 to August 2016
Breakthrough Clinical Trials San Bernardino, CA
Responsible for site management, protocol adherence, site support activities, monitoring and/or coordinating (as needed) of sponsor initiated clinical research studies for central nervous system disorders. Responsible for monitoring sponsor initiated and clinical research studies for general medicine and psychological normal volunteers and subjects diagnosed with, Schizophrenia, Alzheimer's, and Opioid studies:   
  • Site monitoring  preparation and internal audits from site selection to site close out (Site prep and internal audits).
  • Screened and recruited subjects based on eligibility criteria for project participation. 
  • Investigator site identification process and site selection visit prep
  • Training and presentation site personnel during SIVs prep
  • Interim site monitoring visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication.
  • Site "booster" enrollment strategies and visits
  • Training and re-training of new research personnel, including Study Coordinators, Investigators and other staff as required during the study
  • Work closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff. 
  • Gather and maintain documentation for site specific files in accordance with FDA regulations and company SOP's 
​​Studies: XXXX: A study for patients with mild cognitive impairment or mild dementia due to Alzheimer's Disease. XXXX: A phase 2, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Effect of Add-on XXXXXX on Schizophrenia Negative Symptoms XXXX: An Open-Label, Multi-Center Trial to Assess the Safety and Effectiveness of XXXXX in Patients with Schizophrenia  
Education
Master of Art: Ethics 2011 Dominican House of Studies Washington DC, District of Columbia
Bachelor of Art: Philosophy 2005 National Missionary Seminary, Abuja, Nigeria.
Certifications : CRA, IATA, GCP, ICH
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