Clinical Research Coordinator

Location : IC: NHGRI Street: 31 Center Dr. Bldg.: 31 Room: B1B54 City: Bethesda State & Zip: MD 20892

Weekly Hours FT: 3040 hours per week Total No. of Hours : 40

Overall Position Summary and Objectives

The position will independently provide support services to satisfy the overall operational objectives of the National Human Genome Research Institute (NHGRI)

Min Education Bachelors

Payrate $49.34 hourly on W2

Certifications & Licenses

• Masters degree in a related discipline and six years experience
• Masters degree in a related discipline and 2 years of experience

Skills (Ranked by Priority)

1. Interviewing
2. Screening
3. Obtaining Informed Consent
4. Data Integrity
5. Project Management
6. Scheduling

1 2 3 4 5 represents priority rankings where 1 is highest priority and 5 is lowest priority of those ranked

Software

• MS Office

Field of Study

• Clinical Psychology
• Counselling Psychology
• Clinical Psychology
• Counselling Psychology

Statement of Work Details

Other

• Coordinate participant visits including scheduling appointments arranging admissions and incentivization. 1
• Coordinate biospecimen collection and processing of samples.
• Collaborate with research team to evaluate each case; evaluate all study results.
• Maintain communication with participants and their families.
• Provide referrals to mental health resources and providers. 5
• Perform maintenance of research databases and participant research paper charts.
• Work with staff on study related activities for other ongoing research protocols within the Social Network Methods Section.
• Perform literature searches and reviews in the field of behavioural and social sciences in order to design a research study.
• Work with team to plan and implement social and behavioural research projects. 4
• Work with team to develop survey instruments.
• Work with team on the development of behavioural intervention materials and health communications.
• Coordinate recruitment of study subjects for trials.
• Collect data through interviews with participants. 2
• Monitor data collection and communicate with participants as needed for behavioural and social science research. 3
• Work with team to enter organize and store data.
• Perform preliminary analyses of data to address behavioural research questions.
• Coauthor reports and research papers for publication in peerreviewed journals.
• Prepare scientific slides graphics and PowerPoint presentations.
• Present data at conferences.
• Contribute to the development of new study protocols.

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.
• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
• Participate in developing and maintaining research protocol documentation and operations.

Collects research data and prepares information for inputs and analysis.

• 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 staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.
• Review draft protocols case report forms and manuals of operations for clarity and completeness.
• Work with staff on the design development and preparation of documents such as spreadsheets letters rosters agendas presentations and meeting minutes/summaries.

Supports the collection of data from patient charts medical records interviews questionnaires and diagnostic tests.

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

Monitors subjects progress and reports adverse events.

• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
• Assist staff writing progress reports and contributions to peerreviewed scientific manuscripts.
• Update and maintain logs and records of patient and family contacts.

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 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 webbased tools.

• Manage participants study progress in the tracking 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.
• Update annual status of recruitment/enrolment in NIH Human Subjects Reporting System.

Provides assistance to staff in the collection development and quality control of essential clinical research efforts.

• Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol Standard Operating Procedures (SOP) and utilizes approved forms templates and practices.
• Schedule and participate in monitoring and auditing activities and coordinate responses to audits.

Supports clinical staff develop implement and maintain clinical research data files and materials.

• Prepare and submit for review accurate source documents related to all research procedures.

Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.

• Organize prepare and distribute informational materials and provide support to the educational mission of the study.