CLINICAL RESEARCH SPECIALIST, SR - DEPT OF ORTHOPAEDICS

Location
Durham, NC
Posted
Jun 12, 2018
Institution Type
Four-Year Institution

diversity employer



CLINICAL RESEARCH SPECIALIST, SR - DEPT OF ORTHOPAEDICS
Orthopaedics

This position is located in the Michael W. Krzyzewski Human Performance Laboratory (K-Lab) located at the Center for Living Campus at 3475 Erwin Road in Durham, NC 27705.The research focus of the Michael W. Krzyzewski Human Performance Lab (K-Lab) is the preservation of long-term joint health through injury prevention and rehabilitation following injury. In order to accomplish these goals, the K-Lab brings together a multidisciplinary team of orthopaedic surgeons, biomedical engineers, kinesiologists, physical therapists, and athletic trainers.

Occupational Summary

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 a Clinical Research Coordinator or similar CRU/Oversight Organization designee. Participate in day-to-day operations related to the collection,compilation, and documentation of clinical research data

Work performed:

Operations:- Screen participants for all studies independently.- Maintain subject level documentation for all studies independently- Schedule participants and conduct visits for minimal risk studies independently.- 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. 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 under supervision.- Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision.- Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.

Ethics:- 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.

Data:- Map a protocol's data flow plan: data capture, storage, management,quality, and preparation foranalysis- Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.- Enter data accurately. Score tests and measures according to protocol, and appropriate to role.Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.- Use required processes, policies, and systems to ensure data security and provenance. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.- Run summaries and reports on existing data Assist with development of and follow SOPs for dataquality assurance.- Summarize study results

Leadership:- Encourage and support colleagues in completing project work.- Assist research colleagues in identifying efficiencies and improving process.- May serve as mentor to other staff. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.- Maintain Duke and project specific training requirements.

Study and Site Management:- Maintain study's compliance with institutional requirements and other policies (e.g., NIH PublicAccess policy, ct.gov,Research Data Security Plans, Social Media policy, etc.).- Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.- Prepare items for site initiation visits.- Participate in sponsor required training- 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

Communication:- Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.- Participate in study teammeetings.- 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.

Skills required:- Can easily use computing software and web-based applications (e.g.,Microsoft Office productsandinternet browsers).

Requisition Number
401437706

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
803 CLINICAL RESEARCH SPECIALIST, SR

Job Family Level
09

Exempt/Non-Exempt
Non-exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications

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.


Education

Work requires an associates degree.

Experience

One year of relevant experience (e.g., research, clinical, interactionwith study population, program coordination).

Auto req ID

101777BR

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.

PI102897813

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