Clinical Trials Coordinator

Location: Bethesda, MD
ERPi is providing business operations transformation support to the National Heart, Lung, Blood Institute (NHLBI).  NHLBI provides global leadership in research, training, and education to prevent and treat heart, lung, blood and sleep disorders.  ERPi provides a range of consulting services to mission-support functions to include:  shared services development and support, scientific program management, IT program management, business and data analytics and communications. ERPi is seeking a Clinical Trials Coordinator with 5 years of experience to join a high performing team that supports NHLBI in program management, studies and analysis, and consultative advice on emerging trends and issues impacting decision making by NHLBI.
 
The Role:
The NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI is part of the National Institutes of Health (NIH), which is one of 11 agencies that comprise the Department of Health and Human Services (DHHS). It is located on the NIH campus at 9000 Rockville Pike, Bethesda, MD 20892, with additional facilities and offices in Bethesda, MD. The NHLBI recognizes that to further its scientific mission and stewardship of federal funds it must undertake direct efforts to create more accountable and more efficient programs that work for the American people. ERPi  assists the NHLBI with optimizing technology, making data driven decisions and improving performance of heart, lung, blood and sleep scientific programs to effectively and efficiently deliver those programs. To support the NHLBI, ERPi is currently seeking an experienced Clinical Trials Coordinator (CTC), who will be responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Manager, the Principal Investigator and the Medical Director. The CTC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CTC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.
 
Functional Responsibilities:
  • Coordinates with clinical staff to independently develop, implement and manage clinical research data files and materials.
  • Assembles, develops and reviews new research projects.
  • Organizes and performs clinical research, utilizing internet and other available clinical resources.
  • Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
  • Collects research data, prepares information for input and analysis and prepares reports.
  • Assists in the creation/ management of clinical website.
  • Develops/maintains research protocols, and educates staff.
  • Coordinates the development of forms and questionnaires.
  • Coordinates procedures to collect data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
  • Monitors subject’s progress and reports adverse events.
  • Administratively and clinically manage an average of six to eight clinical trials
  • Adhere to Research SOP’s
  • Adhere to Good Clinical Practices and the study protocols
  • Ensure scientific integrity of data and protect the rights, safety, and well-being of patients
  • enrolled in clinical trials
  • Discuss study protocols with patients and verify the informed consent documentation
  • Provide patient with written communication of their participation (i.e. copy of the signed
  • informed consent)
  • Ensure patient’s referring physician receives notification of patient’s participation in
  • studies as requested by the patient
  • Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study
  • Dispense study medication in a professional and accountable manner following protocol requirements
  • Collect, process, and ship blood/urine specimens at scheduled patient visits
  • Perform ECGs and obtain vital signs of patients
  • Schedule all patient research visits and procedures consistent with protocol requirements
  • Complete and maintain case report forms per FDA guidelines, and review them against
  • the patient’s medical record for completeness and accuracy
  • Administer questionnaires/diaries per protocol
  • Ensure that non-serious and serious adverse events are properly documented and reported
  • Screen all laboratory results when received and follow protocol procedure regarding abnormal results
  • Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder
  • Submit patient reimbursement requests at the conclusion of patient’s participation in protocol
  • Ensure the filing and maintenance of all regulatory documents
  • Schedule monitor visits and set up for monitoring visits prior to monitor’s arrival
  • Other duties as assigned.
     
Required Skills and Experience:
  • Minimum/General Experience:
  • Five (5) years of experience in clinical research or a related field.
  • Demonstrates superior experience with data collection. Demonstrates
  • experience with Microsoft Office (Word, Excel, etc.). Demonstrates
  • superior knowledge of research protocols and clinical, scientific and/or
  • medical terminology.
  • Minimum Education:
  • Master’s degree in a related discipline. Three (3) years of specialized
  • experience plus a BA/BS degree is equivalent to a Master’s degree.
     
Desired Skills and Experience:
  • Able to read, analyze, and interpret information from professional journals, technical
  • procedures, or governmental regulations.
  • Able to effectively present information and respond to questions from physicians, staff
  • and patients.
  • Knowledge of Good Clinical Practices and the regulations necessary for the protection of
  • human subjects and the conduct of clinical research required. Knowledge of the
  • International Air Transport Association (IATA) regulations for the transportation of
  • Dangerous Goods also necessary.
  • Knowledge of EMR system
  • Able to function effectively in a team setting
  • Needs to demonstrate consistent professional conduct and meticulous attention to detail
  • Must possess excellent verbal and written communication skills as well as excellent
  • interpersonal skills with patients, staff, and other health care professionals.
  • Required to sit for CCRC after 2 years experience
     
Clearance: Public Trust
 
ABOUT ERPi:
Enterprise Resource Performance Incorporated (ERPi) is a service-oriented professional management consulting firm delivering strategy, advisory, technology and implementation support services to Federal Government Agencies. ERPi combines client domain experience with a distinctive consulting methodology called CAM (collaborative advisory methodology) http://www.erpi.net/how-we_serve/ and industry best practices to deliver innovative and sustainable performance improvements for our clients. ERPi sets itself apart and provides impact through the way we work with clients, each other and our teaming partners. Born from a culture that is built on trust, integrity and being of service to others, we deliver our proprietary consulting methodology and rigorous analysis to help our clients solve complex challenges and achieve some of the most challenging missions of the Federal Government. This allows us to attract the best and brightest talent who want to tackle complex client issues in ways that make a difference. Our skilled consultants bring technical expertise and industry experience, but not all the answers. They listen to our clients and tailor solutions to their unique business situation. They are driven by the desire to help clients identify creative, sustainable solutions to their problems. ERPi is committed to creating an environment for professional growth and success for our talented professionals. ERPi’s compensation and benefits plan is designed to attract and retain the industry’s most capable professionals.
 
EEO Statement:
It has been and will continue to be a fundamental policy of ERPi not to discriminate on the basis of race, color, religion, sex, gender, sexual orientation, gender identity or expression, pregnancy, parental status, marital status, citizenship, national origin, age, disability, genetic information, military status, veteran status, or any other protected category with respect to recruitment, hiring, training, promotion, and other terms and conditions of employment.
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