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Position Objective: Provide services as a Clinical Research Coordinator in support of the overall functions of the National Cancer Institute, within the National Institutes of Health (NIH). Under this task order the contractor will independently provide support services to satisfy the overall operational objectives of the National Cancer Institute, Division of Cancer Epidemiology and Genetics. The primary objective is to provide services and deliverables through the performance of support services.

Duties and Responsibilities:

• Assist preparing and submitting for review accurate source documents related to all research procedures.

• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). 4

• Participate in developing and maintaining research protocol documentation and operations.

• Assist researchers with study testing, observations data entry and other duties associated with study sessions.

• Verify study participant information and collect data and results of testing.

• Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols.

• Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.

• Set up, format and enter data into spreadsheets to analyze information and create reports.

• Enter data into research databases, systems and applications for ongoing studies.

• Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in the research record e.g., source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents

• Anticipate and consistently meet reporting deadlines, collaborating with PIs and teams to note data trends and identify problems

• Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.

• Assists the research team with data extrapolation, entry, cleaning, and overall quality assurance of incoming and historical data 3

• Verifies study participant information and collects data longitudinally

• Assist researchers develop, maintain and complete study data collection forms and source documents.

• Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.

• Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.

• Organize, prepare and distribute informational materials and provide support to the educational mission of the study to both the study team as well as participants

• Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations. 5

• Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.

• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.

• Assist researchers with the collection and analysis of research data and samples.

• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.

• Update and maintain logs and records of patient and family contacts.

• Maintain the privacy and confidentiality of participant and research data; Protects participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information

• Assists with managing and retrieving data from the electronic medical record system at the NIH Clinical Center (CRIS), dissemination of surveys, and data collection from participants 2

• Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

• Assist researchers obtain IRB approval before any study related activities begin.

• Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures.

• Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures. 1

• Assist researchers develop and maintain current and new research protocols.

• Research changes and updates to Good Clinical Practices (GCP) and prepare summaries, job aids and training materials for research staff and new clinical research coordinators.

• Maintain content on the Clinical Studies websites (resources for staff and extramural investigators).

• Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.

• Provide quality and detailed feedback on the development of new study and data management features.

• Upon request, the contractor shall provide documentation evidence of any and/or all work product, including, but not limited to, the following tasks:

• Work products and documents related to managing branch projects and data; coordinating epidemiologic study implementation and data collection.

• Work products and documents related to designing and supporting analysis of questionnaires, surveys, protocols, informed consent documents, training manuals, SOPs, and database management systems.

• Work products and documents related to managing IRB submissions for branch protocols.

• Work products and documents related to preparing data summaries, organizing and enhancing websites.

  Basic Qualifications:

• Bachelors Degree in Miscellaneous Health Medical Professions or a related discipline.

• Clinical Research Coordinator certification (CCRC).

• Skilled in ServiceNow, Qualtrics, Medidata, and MS Office.

• Experience in clinical research.

• Has ability to work independently and function within a team with strong attention to detail.

  Minimum Qualifications:

• Ability to multi-task and pay close attention to detail.

• Excellent analytical, organizational and time management skills.

• Strong communication skills, both oral and written.

• Reliable and able to prioritize competing responsibilities.

  *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

  GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

  This position is contingent upon contract award.

Requisition ID: 7061