CLINICAL RESEARCH COORDINATOR

Location
Durham, NC
Posted
Jun 14, 2018
Institution Type
Four-Year Institution

diversity employer



CLINICAL RESEARCH COORDINATOR
Heme Clinical Rsch

Occupational Summary
Coordinate and participate in clinical research studies conducted by principal investigators from multiple specialties within Heme-BMT at Duke Health; including corporate sponsored clinical trials conducted on site at Duke Cancer Institute. Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
Maintain a close, collaborative working relationship with the PIs in Heme-BMT to effectively manage research studies, with the Heme-BMT Oncology Division, with the Duke Cancer Institute (DCI) & OncCRU administrative teams. Build and maintain effective relationships with key study personnel, clinical resources and regulatory colleagues within the OncCRU.
Responsibilities and Expectations
Clinical Trials Operations
Coordinate and participate in clinical research studies conducted by principal investigators at Duke Health; coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
Build and maintain effective relationships with key study personnel, clinical resources and regulatory colleagues within the OncCRU, the DCI, and throughout Duke Health.
Assist in the determination of guidelines for the collection of clinical data and/or administration of clinical studies.
Enter MaestroCare information at the time of enrollment, linking the patient to the Research Subject Record (RSH) record, to the study encounter and the timeline prior to close of the study encounter. Maintain current enrollment logs on all consented studies.
Monitor and ensure all consented patients are entered into the Clinical Trials Management System (CTMS) - currently OnCore - within School of Medicine policy deadlines, as well association completion in MaestroCare. Monitor and ensure all Oncology required fields are entered into the CTMS to facilitate the annual DCI reporting requirements. Monitor and ensure all patients statuses in CTMS are updated as appropriate (consented, enrolled, end billing, etc.).
Ethics and Participant Safety
Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis. Process samples per protocol guidelines.
Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and inconsistencies and monitor patient's progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.
Screen patients for inclusion in non-chemotherapy studies based on pre-determined criteria and register patients appropriately.
Complete informed consent process with patients, ensure eligibility requirements are met and follow protocol guidelines for non-chemotherapy clinical trials.
Provide protocol specific service to patients within the age group 18 and over.
Leadership and Professionalism
Apply professional guidelines and code of ethics. Recognize cultural diversity. Demonstrate the principles of leadership, management, and mentorship, and apply them within the team and daily work.
Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; ensure adherence to FDA and protocol guidelines, identify potential problems and/or inconsistencies and take action as appropriate.
Review protocol to determine feasibility of conducting the study.
Collaborate with principal investigators and other members of the research team in the development of plans and protocols for clinical research studies' contribute to the ongoing analysis and modification of protocols as appropriate.

Inspect study files to ensure completeness and accuracy of data.
Coordinate preparation for monitoring visits, timely query follow up and completion. Assist as required for timely resolution of regulatory related queries with IRB, study sponsors, and CRO. Assist with data correction/queries as required and complete in a timely manner.
Provide guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies.

Communication and Teamwork
Utilize effective communication strategies with team, customers and colleagues. Work effectively with multidisciplinary and inter-professional team. Collaborating with colleagues as a team member is vital to the program's effectiveness.
Attend required Clinical Research Coordinator (CRC) meetings and divisional staff meetings.
Participate in and complete designated and/or required training [Clinical Research Unit (CRU), GCP, CITI modules, MaestroCare, Beacon, IRB, etc.]
Expectations
Effectively manage your workload, seeking help whenever it's needed. Communicate frequently with your manager, keeping them up-to-date on your work and issues as they arise. You will work closely with your manager to implement departmental & Duke policy and initiatives.
Adherence to core work hours; time off requests will be submitted to your manager per departmental & Duke policy. Patient care is our primary mission. When the unexpected happens you may be called upon to provide coverage outside your core work hours.
Know and comply with the regulations, rules and Standard Operating Procedures for your department, Duke Health, School of Medicine, OncCRU and the Duke Office of Clinical Research.
Comply with Duke's rules, regulations and responsibilities as noted in The Duke Employee Handbook and on the Duke HR website.
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.


Requisition Number
401414387

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 degree, 2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).

Skills
  1. Excellent written, oral and conversational communication skills to effectively work with diverse groups.
  2. Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills.
  3. Excellent time management skills needed to prioritize among many competing priorities.
  4. Attention to detail needed to operate accurately and effectively in the regulatory environment.
  5. Mastery of Microsoft Office, especially Word and Excel, multiple electronic databases and computer based information systems including eIRB and Microsoft Access.
Preferences
The preferred candidate will have clinical research experience, training, and/or education.


Auto req ID

100259BR

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.

PI102926314

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