CLINICAL RESEARCH COORDINATOR - PEDS


diversity employer



CLINICAL RESEARCH COORDINATOR - PEDS
Pediatrics-Critical Care Med

Operations:Screen participants for all studies independently. Maintain subject level documentation for allstudies independently Schedule participants and conduct visits for allstudies independently. Train others to conduct and document visits and protocol-specifictesting/interviews. Assist with development and follow procedures and documentation of study payment in timely fashion.Independently maintain appropriate study-level documentation includingregulatory binders,enrollment logs, patient registration in the system of record, etc.Employ strategies to maintain recruitment and retention rates, and to assist participants withindividual 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 toinstitution and sponsor-specific prompt reporting requirements (timelines and forms)independently. Have familiarity with intellectual property rights, inventions patents, andtechnologies. As appropriate, understand regulations related to investigational products with sponsors.Coordinate with Duke core servicessuch as Investigational Drug Service (IDS), Biobank, etc. Recognize the need for agreements(e.g.,Material Transfer Agreements, Investigational New Drug Applications,etc.). Develop DUHS IRBdocuments such as consent forms, protocols, and continuing reviews independently.

Ethics:Recognize when patients are having difficulties with this distinction.Make recommendations regarding how to improve communications to help patients and staffunderstand the distinction.Identify and the explain the risk and benefits to a subject as thesepertain to your clinical trialData: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. Recognize and report vulnerabilities relatedto security of physical andelectronic data. Assist in investigating incomplete, inaccurate ormissing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA. Recognize when data agreements are necessary

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. Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research.

Study and Site Management:Make recommendations to investigators and oversight organization regarding 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 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: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 routinequestions 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. Special Skills: Candidate must have clinical trials experience preferably in pediatric population.

Requisition Number
401282963

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 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

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

91391BR

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.

PI98416149