CLINICAL RESEARCH COORDINATOR, SR
CLINICAL RESEARCH COORDINATOR, SR
Phase 1 Clinical Research
Participate in human subject clinical research studies conducted by principal investigators (PIs) of the Phase I Program. The studies are overseen by the Oncology Clinical Research Unit (OncCRU) within the Duke Cancer Institute (DCI). Perform study-specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study- specific protocols/plans and processes under the direction of a supervisor.
Clinical Research Operations, Design best methods for management of IP. Oversee implementation of and compliance with the required system for handling, dispensing and documentation of IP for sponsored protocols. Serve as an expert resource for study teams, DUHS procurement, billing and compliance for the proper handling of Investigational Product (IP). Participate in or lead development of policies and guidances related to study level documentation. Participate in or lead development of policies and guidances related to subject recruitment. Serve as an expert resource across unit or department. Participate in or lead development of policies and guidances related to monitoring and audits. Serve as an expert resource when addressing and correcting findings. Oversee the collection of adverse event information for an entire unit or department Provide input for AE reports. Serve as a resource to junior staff as well as the unit, department, or division staff with regard to institution and sponsor-specific prompt reporting requirements (timelines and forms). Liaise with contact for final determination of safety event outcome. Possess thorough understanding of intellectual property rights, inventions, patents, and technologies. Coordinate with Duke core services such as Investigational Drug Service, Biobank, etc. Coordinate necessary agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
Ethical and Participant Safety Considerations- Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. Provide unit, division or department-wide training in ethical conduct of research. Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
Data Management and Informatics- Predict areas of vulnerability for data flow for multiple studies or across a unit, department or division. Design data flow plans that include elements related to data capture, storage, management, quality, and preparation for analysis; implement across multiple studies or at unit, department or division level. Serve as unit/departmental/institutional resource on ECRFs, EDCSs, technologies, and software to ensure highest quality data collection and capture May assist with development of, or develop, guidelines and policies related to research data provenance and security. Serve as unit/departmental resource to others regarding data provenance and security. Develop system/framework for QA processes for multiple studies or for entire unit. Develop unit/department - wide quality assurance systems for research data; oversee implementation. Make determinations regarding complex data contracts/agreements
Scientific concepts and research design- Conduct and synthesize literature reviews independently Assist with development of research proposals or protocols. Summarize and interpret study results, and determine application to future study procedures.
Leadership and Professionalism-Provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups. Successfully lead a committee, task force, or ad hoc group at the division, unit, department or institution level. Lead cross-functional committees or task forces charged with improving study processes. Independently lead scientific or programmatic presentations or publications. Serve as leader to entire unit/department. Define vision and direction. Create policies and guidelines at the unit/departmental level to allow staff to follow professional guidelines and code of ethics. Maintain training requirements and develop solutions to proactively ensure unit, department, division's compliance with training requirements. Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research.
Study and Site Management- Oversee unit/department level processes related to research resources and finances. Provide leadership/training to entire unit/department with regard to compliance with institutional requirements and other policies Work with sponsors and study teams to arrange required sponsor training. Provide feedback to the study team members; and serve as an institutional resource to the study visitors Develop systems and documents including process flows, training manuals, and standard operating procedures to be used unit, department, or division-wide. Create unit-wide (and collaborate to create institution-wide) policies and guidelines regarding study closeout and document storage.
Communication and Team Science- Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. Prepare for and lead unit, departmental, or division-wide meetings. Mentor junior staff to improve ability to participate in team efforts.
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.
1202 CLINICAL RESEARCH COORDINATOR, 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, genetic information, gender, 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.
Work requires one of the following:1.Completion of a Bachelor's degree and a minimum of four years of research experience. 2.Completion of an Associates degree plus a minimum of six years of research experience. 3.Completion of a Master's degree and a minimum of 2 years of of research experience.
The preferred candidate will have oncology or research experience, training, education.
Expertise and high level experience with the management of clinical trials activities, including monitoring of trials and other project management experiences, specifically data collection activities, data quality monitoring, clinical trials procedures, etc
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.