CLINICAL RESEARCH SPECIALIST, SR


diversity employer



CLINICAL RESEARCH SPECIALIST, SR
GU Clincial Rsch

Overview
Perform a variety of research, data base and clerical duties of a complex and technical nature in support of clinical research studies conducted by principal investigators (PIs) for the GU Clinical Research Program (GU); to ensure adherence to protocols and quality of information received.
You will maintain a close, collaborative working relationship with the PIs in your department to effectively manage research studies, with the GU department, with the Duke Cancer Institute (DCI) & Oncology Clinical Research Unit (OncCRU) administrative team, and the Oncology department staff. You will build and maintain effective relationships with key study personnel, clinical resources and colleagues throughout Duke.

Responsibilities and Expectations

Operations
Screen participants for minimal risk studies. May 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. Collect, prepare, process, ship, and maintain inventory of research specimens. Assist with maintenance of study level documentation. Define source document. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. 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 Clinical Research Coordinator (CRC) or Clinical Research Nurse Coordinator (CRNC). Prepare for study monitoring and study audit visits. Collect, prepare or process adverse event information under supervision. Provide input for adverse event reports.

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. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial

Data
Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis. 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. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA.

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. 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. Take part in site initiation/closeout visits as directed. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.

Communication
Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. 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. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.

And other work as assigned.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Preferences
The preferred candidate will have oncology or research experience, training, education.

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

The preferred candidate will have oncology or research experience, training, education.

Requisition Number
401281500

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 Employercommitted to providing employment opportunity without regard to anindividual'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 mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable 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

91214BR

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.

PI98227915