CLINICAL RESEARCH SPECIALIST, SR
CLINICAL RESEARCH SPECIALIST, SR
Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of OBGYN CRU Research Practice Manager. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.
- Screen participants for minimal risk studies.
- screen participants for studies with greater than minimal risk, under supervision.
- Maintain subject level documentation for minimal risk studies, or for other studies under direction.
- Schedule participants and conduct visits for minimal risk studies independently.
- Improve systems related to specimen handling.
- May collect, prepare, process,transport, ship, and maintain inventory of research specimens and train others in these tasks.
- Collaborate to 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 minimal risk studies.
- May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC.
- Prepare for study monitoring and study audit visits.
- Collect, prepare or process adverse event information under supervision.
- Provide input for adverse event reports.
- Provide input for DUHS IRB documents such as consent forms,protocols, and continuing reviews.
- 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.Identify and explain the risk and benefits to a subject as these pertain to your clinical trial.
- Map a protocol's data flow plan: data capture, storage, management,quality, and preparation for analysis.
- Train others on study team in use of technologies and software, and in completion of ECRFs.
- Assist with the development of data collection documents to standardize process.
- Use EDC systems and enter data accurately.
- Use required processes,policies, and systems to ensure data security and provenance.
- Assist in investigating incomplete,inaccurate or missing data/documents to ensure accuracy and completeness of data.
- Follow SOPs for data QA.
- Conduct literature reviews under the direction of the CRC, CRNC, or PI.
- Determine operational/statistical elements needed for the conduct of clinical and translational studies.
- Assist research colleagues in identifying efficiencies and improving process.
- Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
- Maintain Duke and project specific training requirements.
- 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 Media policy, etc.).
- Assist with the development of protocol-specific systems and documents including process flows,training manuals, standard operating procedures, and case report forms.
- Prepare for closeout and document storage.Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.
- 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.
- Support minimal risk research projects in collaboration with CRCs.
- One project involves recruitment from multiple local Duke Clinics.
- Responsibilities include conducting research visits under CRC guidance, phlebotomy, completing study related documentation,monitoring inventory of supplies, ordering supplies, tracking and transporting specimens,and reviewing and reconciling financial reports.
- Additional responsibilities include working with PIon grant and manuscript preparation including compiling and editing documents, and preparing reports.
Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification.
This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Ability to learn new software programs under appropriate guidance and instruction, excellent writing and editing skills (a writing sample may be requested), excellent time-management skills.
803 CLINICAL RESEARCH SPECIALIST, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.
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.
Work requires an associates degree.
One year of 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.