Clinical Research Coordinator

Job Title: Clinical Research Coordinator

Location: Bethesda MD 20814

Duration: 3 Years to Permanent

Shift: 40 Hours/Week (Mon to Fri)

Teleworking Eligible: Yes

Onsite: Yes

Position Requirements

Overall Position Summary and Objectives

• The primary role for this Research Coordinator (RC) position is to provide clinical research coordination and protocol navigation for the Intramural Research Program.

Min Education:

• Bachelor's

Certifications & Licenses:

• Association of Clinical Research Professionals Certified
• Professional (ACRP-CP) - Association of Clinical Research
• Professionals (ACRP) - Certified Clinical Research
• Professional (CCRP) - Certified Clinical Research Coordinator
• (CCRC) - Certified Clinical Research Associate (CCRA)

Field of Study:

• Miscellaneous Health Medical Professions
• Nursing Community and Public Health
• General Medical and Health
• Neuroscience
• Miscellaneous Biology
• Cognitive
• Science and Biopsychology
• Biology
• Genetics
• Health and Medical Preparatory Programs
• Nutrition Sciences - Pharmacy
• Pharmaceutical Sciences and Administration
• Treatment Therapy
• Communication Disorders Sciences and Services Sociology
• Interdisciplinary Social Sciences
• Miscellaneous Psychology
• Clinical Psychology
• Social Psychology
• Social Work
• Chemistry
• Multi-Disciplinary or General Science

Software:

• Clinical Trial Management System (CTMS)
• Electronic Medical Records System
• Electronic Data Capture System

Skills:

• Overseeing and documenting IP dispensing, inventory and reconciliation
• Closing clinical trial sites down on completion of clinical trial
• Ordering, tracking, and managing IP and trial materials
• Implementation of clinical trial site action plans
• Training clinical trial site staff
• Coordinating project meetings
• Previous clinical trial work
• Electronic medical records
• Protocol review revision Phase I or II experience
• Remote site monitoring
• Regulatory compliance
• Protocol development Clinical Research
• Protocol writing
• Clinical Trials
• Recruitment Scheduling
• ICH/GCP
• SOPs Liaising with regulatory authorities
• Liaise with ethics committee Protocol navigation
• Regulatory affairs
• IRB submissions

Statement of Work Details:

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.
• Assists clinical and research staff ensure that Case Report Forms (CRFs) are completed and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields.
• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
• 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.
• Maintains all professional certifications, if applicable
• Maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to
• serve as an expert resource to the client in a regularly changing field, and addresses identified knowledge and skill gaps related to role.
• Show initiative and strong independent problem-solving skills in making recommendations for improving research team processes in general, and as needed to efficiently resolve complex or unpredictable situations.
• Identify inefficiencies and recommend changes to research protocol documentation procedures that can improve study productivity.

Collects research data and prepares information for inputs and analysis:

• 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.
• Verify study participants information and collect data and results of testing, including verification data for eligibility criteria.
• Assist researchers in collecting, organizing, and maintaining accurate records of all protocols and study applications, investigator qualifications, study logs, safety reports, annual reports, and correspondence.
• Monitor research team training requirements, including maintaining all training records and providing notifications for training renewal deadlines.
• Supports the development of forms and questionnaires.
• Assist researchers develop, maintain and complete study data collection forms and source documents.

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.
• Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.
• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
• Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests.
• Assist researchers with the collection and analysis of research data and samples.

Monitors subject's progress and reports adverse events:

• Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
• 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.
• Provide continuity of care to patients enrolled on assigned protocols.
• Assesses participants understanding of the information provided during the informed consent process.
• Assesses ongoing consent through discussions with participants and reinforcement of education.

Supports assembly, development and review of new research projects:

• 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 researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
• Contributes to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, data quality, and recommend operational improvements..

Supports the creation and management of clinical websites and web-based tools:

• Maintain content on the Clinical Studies websites (resources for staff and extramural investigators).
• Assist researchers register studies on clinicaltrials.gov.
• Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.

Organizes and performs clinical research, utilizing internet and other available clinical resources:

• Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms.
• Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.