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CLINICAL RESEARCH COORDINATOR - PEDS/NEONATOLOGY

Job description


diversity employer



CLINICAL RESEARCH COORDINATOR - PEDS/NEONATOLOGY
Pediatrics-Neonatology

Operations: 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. Improve systems related to specimen handling. May 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 atthe 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 and provide training to others in these tasks. 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. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independentlyandtrain other staff in these tasks.

Ethics: Recognize when patients are having difficulties with this distinction.Make recommendations regarding how to improve communications to help patients and staff understand the distinction. Train junior staff inthe ethical conduct of research, and provide guidance in strategies used to maintain safety. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans(DSMPs)/Research DataSecurityPlans (RDSPs). Assist with the coordination of efforts of external monitoring boards. Identify and explain the risk and benefits to a subject as these pertain to yourclinical trialData:Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies. 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. Recognize and report vulnerabilities related to security of physical and electronic data. Suggest and implement solutions to vulnerabilities related to security of data and data provenance 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. Develop and follow SOPs for data QA. Monitor QA of study data. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)

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 ofclinical 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 Accesspolicy,ct.gov, Research DataSecurity Plans, Social Media policy, 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 Recognize components of operational plans and be able to obtain information needed to develop the plan. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Take part in or lead closeout and document storage activities.

Communication: Take action when communication has stalled with sites, CROs, sponsors. Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately.Expand on the ideas of peers or team members. Take an active role in including others in decision-making.

Description of Portfolio and Clinical Responsibilities: This person will work with the Neonatal Perinatal Research Unit and will be in direct contact with patients and families daily. This person will work as a CRC managing multiple studies at one time and function as a team member. Ability to multi-task and handle many studies at one time. Working with a vulnerable population of babies in the NICU.

Requisition Number
401515928

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1201 CLINICAL RESEARCH COORDINATOR

Job Family Level
52

Exempt/Non-Exempt
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

1.Completion of a Bachelor's degree2.Completion of an Associates degree plus a minimum of two yearsrelevant experience (e.g., research, clinical, interaction with studypopulation, program coordination)

Auto req ID

106716BR

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.

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Job No:
Posted: 11/8/2018
Application Due: 11/15/2018
Work Type:
Salary: