CLINICAL TRIALS COORDINATOR I,DCRI - Outcomes

Location
Durham, NC
Posted
Oct 05, 2017
Institution Type
Four-Year Institution

diversity employer



CLINICAL TRIALS COORDINATOR I,DCRI - Outcomes
DCRI - Outcomes

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.


This new Site Coordinator would join the DCRI Outcomes Research and Assessment Group to work on clinical registry projects. This individual would work closely with the Project Lead (PL) as a DCRI data liaison with participating STS sites.

DCRI serves as data warehouse coordination and analysis center for multiple clinical registries, across the US. Typically, between 500 and 1000 sites participate in each registry. Project activities include communication/cooperation with sponsor organization (government, nonprofit, industry), processing of incoming data, communication with clinical sites, standard reporting on data, coordination and implementation of academic research (e.g. analysis and manuscript development) using the data. Responsibilities specific to the Site Coordinator are as follows:

Responsibilities:

General:
Independently assume specific activities within established projects and for new projects, as directed by the PL:
  • Create and maintain project- and task- specific documentation
  • Accountability for meeting and monitoring project deliverable timelines
  • Coordination of all staff involved in the task (planning meetings, distributing relevant documents/files, assigning tasks)
  • Under the guidance of the PL, lead problem solving initiatives necessary to meet project goals
  • In coordination with PLs, developing/refining daily project operations
  • Assuring relevant level of process documentation
  • Communication/liaison with sponsoring organization
  • Provide PL and/or PI status reports
  • If applicable, responsible for all IRB documentation, including applications, amendments, and renewals

Project Specific:
  • Serve (within a team) as the first line of communication for participants in the three STS National Databases
  • Primary site support activities include: site contact, data receipt, data management and validation, report production and distribution and quality assurance
  • Create and update data collection information materials for distribution and posting on the client website
  • Maintain and update the participant contact database and initialize new contacts into an on-line data collection tool
  • Develop/revise, assemble and distribute auxiliary reports to 3rd party requesters
  • Recommend mechanisms to streamline procedures to better implement quality control and provide the best utilization of project resources
  • Problem intervention and resolution of data processing, data receipt, coding and data entry errors with participating sites
  • Monitor data collection flow, quality control and data processes
  • Ongoing active collaboration with database programmers, statistical programmers, project management in the implementation of the project.
Skills / Experience
  • Needs enthusiasm for data and necessary skills for working with it including querying databases to resolve site data entry and reporting issues
  • Must be organized and able to multi-task.
  • Independent thinker and ability to complete assigned tasks with minimum supervision
  • Some experience with project coordination - resource management, leading meetings, documentation, etc.
  • Must have strong writing and interpersonal communication skills


Requisition Number
401331420

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1941 CLINICAL TRIALS COORDINATOR I

Job Family Level
79

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Education:

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN). Physician's Assistant (PA) or Pharmacists plus one year healthcare experience, or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of three years healthcare experience; or
2. Completion of a Master's degree in Public Health, Health Administration or a related area with no additional experience; or
3. Completion of a Bachelor's degree plus a minimum of one year directly related clinical trials research; or
4. Completion of a Bachelor's degree plus a minimum of two years closely related research experience.

**State of North Carolina licensure may be required**
Experience:
None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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.



Auto req ID

93851BR

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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