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Global Solutions Network Inc.

Clinical Research Coordinator - NIH

Global Solutions Network Inc., Bethesda, Maryland, us, 20811


Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH). This position provides a competitive salary and comprehensive benefits.

If interested, please provide an up-to-date resume.

Responsibilities .

Greet visitors and respond to telephone calls from patients and their family members, health care professionals and others; refer inquiries as appropriate to section chief, study coordinator supervisor or other health care providers.Work with staff on selected patient care functions for participants enrolled in a large cohort study of patients infected with the Hepatitis C virus HCV; including two other arms of the study for patients with Hepatitis B Virus HBV and sexual partners of enrolled HCV patients.Schedule follow-up visits and blood collection for participants of HCV Donor Study.Contact participants by telephone to schedule follow-up phlebotomy and clinic appointments as specified in study protocol.Prepare patient charts for clinic days; provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab procedure printouts.Send form letter signed by Clinical Studies Coordinator to participants unable to be contacted by phone as a reminder to call and schedule an appointment.Send out blood collection mailer kits to participants who are unable to return to NIH for blood sampling.Schedule HCV study participants for various apheresis procedures in DTM Dowling Clinic, as well as other research or patient care related special exams studies ultrasound, CT, X-ray, Fibro scan, etc.Verify and enter data collected on study participants, including donor, recipient and patient data for participants enrolled in the TRIPS and HCV studies; data may include demographics, medical history, physical exam, laboratory, and pathology results, nursing assessment data and transfusion donor records.Retrieve research related information from medical records, hospital information system, CRIS, and or laboratory information system LIS; create spreadsheets and other reports for use in study analysis.Generate letters for study participants as specified by supervisor on letter request form.Copy and distribute weekly HCV Clinic log to TTV lab, OP 9 clinic, DTM clinicians, and DTM fellows on clinical rotation.Collect TRIPS Study donor consents from DTM donor area and file them in chronological order after study nurse enters consent into DTM donor system.Supports clinical staff develop, implement and maintain clinical research data files and materials.Assist preparing and submitting for review accurate source documents related to all research procedures.Collects research data and prepares information for inputs and analysis.Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols.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.Supports the development of forms and questionnaires.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.Assist researchers design patient Case Report Forms CRFs.Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.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 researchers with the collection and analysis of research data and samples.Monitors subject's progress and reports adverse events.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.Supports assembly, development and review of new research projects.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.Assist researchers develop and maintain current and new research protocols.Supports the creation and management of clinical websites and web-based tools.Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample, collection, and data entry.Supports clinical staff develop, implement and maintain clinical research data files and materials.Assist researchers with study testing, observations data entry and other duties associated with study sessions.Work products and documents related to scheduling follow-up visits and blood collection for participants of HCV Donor Study; contact participants; prepare patient charts; provide initial assessment forms, patient labels most recent medication lists and lab/procedure printouts; send letter to participants unable to be contacted by phone.Work products and documents related to scheduling HCV study participants for various apheresis procedures in DTM Dowling Clinic; verify and enter data collected on study participants.Weekly Work products and documents related to retrieving research related information; generate letters for study participants; copy and distribute weekly HCV Clinic log.Weekly Work products and documents related to collecting and filing TRIPS Study donor consents from DTM donor area; greet visitors; respond to telephone calls from patients and their family members, health care professionals; refer inquiries to appropriate staff.Qualifications .

Associates Degree acceptableMS Office skillsBenefits.

Medical, Dental, & Vision CoveragePaid Time Off and Paid Holidays401K/Profit Sharing PlanFlexible Spending Accounts (Healthcare & Dependent Care)Pretax Parking & Transportation PlanShort-Term & Long-Term Disability InsuranceLife & AD&D InsuranceProfessional Development/EducationEmployee Referral BonusesEmployee Discount ProgramMerit BonusesEmployee Assistance ProgramTravel Assistance Program

Global Solutions Network, Inc. (GSN) is an Equal Employment Opportunity (EEO) employer. It is the policy of the GSN to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected US veteran or disabled status, or genetic information.