CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
Medicine - Hematology
Screen participants for all studies independently.
Maintain subject level documentation for all studies independently
Schedule participants and conduct visits for all studies independently.
Train others to conduct and document visits and protocol-specific testing/interviews.
Assist with development and follow procedures and documentation of study payment in timely fashion.
Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
Assist with management of IP.
Employ the required system for handling, dispensing and documentation of IP for sponsored protocols.
May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary.
Maintain appropriate documentation.
Track IP compliance at the protocol-and subject level. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
Evaluate processes to identify issues related to recruitment and retention rates.
Conduct and document consent for participants in a variety of studies independently
Assist with addressing and correcting findings from study monitoring and study audit visits.
Collect,prepare or process adverse event information independently
Complete and submit AE Reports,according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
Have familiarity with intellectual property rights, inventions patents, and technologies.
As appropriate,understand regulations related to investigational products with sponsors.
Coordinate with Duke core services such as Investigational Drug Service(IDS), Biobank, etc.
Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications.
Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations.
Understand that the safety of research participants is a priority.
Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).
Assist with the coordination of efforts of external monitoring boards.
Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
Map protocol data flow.
Predict areas of vulnerability for a protocol's data flow plan.
Determine areas where data provenance may be compromised.
Use EDC systems and enter data accurately and train others in these tasks.
Detect issues related to data capture, collection or management and suggest solutions.
Use required processes,policies, and systems to ensure data security and provenance.
Recognize and report vulnerabilities related to security of physical and electronic data.
Independently investigate issues related to accuracy and completeness of data.
Develop and run queries and reports.
Recognize trends related to data quality and escalate as appropriate.
Assist with development of and follow SOPs for data quality assurance.
Recognize when data agreements are necessary
Conduct literature reviews independently Identify various stakeholders (statistical, operational,etc.) to ensure adequate design, implementation, and testing of study aims.
Assist with development of research proposals or protocols.
Summarize study results
Encourage and support colleagues in completing project work.
Assist research colleagues in identifying efficiencies and improving process.
Assign, review, and train others in various work responsibilities.
Serve as a mentor to junior staff,including others with my title.
Employ escalation and performance plans as needed.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
Maintain Duke and project specific training requirements.
Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.
Make recommendations to investigative team.
Study and Site Management:
Collect information to determine appropriate feasibility, recruitment and retention strategies.
Ensure participant care expenses have appropriate financial routing in a timely manner.
Monitor financial study milestones and report appropriately.
Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate.
Assist with study budgets.
Maintain study's compliance with institutional requirements and other policies(e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Mediapolicy, etc.).
Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
Take part in site initiation and closeout meetings independently
Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
Coordinate operational plans for multiple research studies.
Take part in or lead closeout and document storage activities
Take action when communication has stalled with sites, CROs, sponsors.
Participate in study team meetings.
Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.
Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
Description of Portfolio and Clinical Responsibilities:
• Other:Type of Research This position will support clinical research studies in the Hematology division sponsored by federal and industry funding
At least one year of clinical research experience with direct patient interaction; knowledge of medical terminology and experience with EPIC is preferred
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
1.Completion of a Bachelor's degree
2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.