CLINICAL RESEARCH ASSOCIATE III, DCRI - Outcomes

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

diversity employer



CLINICAL RESEARCH ASSOCIATE III, 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.


The CONNECT-HF study is designed with a patient centered hospital discharge to home interface emphasis in the care of the advanced heart failure patient (>Class II) to improve the care and application of heart failure evidenced based care and guidelines. All participating CONNECT-HF hospitals will participate in the discharge and out-patient quality improvement program with a registry tool. Hospitals will enroll into CONNECT, be trained on abstracting the Case Report Form information on their discharging HF patients. DCRI will follow all patients at 1, 3, 6, and 12 months. Hospitals will receive quarterly quality reports to review their individual health system discharge care, re-admissions, and medication adherence for the HF patient population. There will be a randomization of the hospitals and a subset of the hospitals will receive a more rigorous QI program for the discharge and follow up care including live and web based training, patient centered behavioral change apps, expert mentor-coaching, sharing best practices with other health systems, and specialized process improvement reports.

Occupational Summary
Lead the development, project coordination, and implementation of educational outcomes operations for the CONNECT- HF intervention. This includes the site management and monitoring administrative responsibilities with guidance, including educational outcomes research processes and system changes, and daily supervision of the outcomes operations team internally and in the field to the successful management of quality improvement implementation outcomes research conducted by principal investigators at the Duke University School of Medicine and Nursing. Along with the principle investigators of CONNECT HF, the CRA 3 is responsible for deploying quality improvement principles and facilitation skills in the training of the faculty mentors for site management and mentorship.

Additional responsibilities include Training of hospital system trainers for the hospital system site personnel training regarding the HF discharge to home management of disease state and implementation project. Once the faculty and hospital site leaders and trainers are in place, the CRA 3 will be responsible for the coordination of the process and outcomes data monitoring in accordance with CONNECT HF operations manual, CONNECT HR registry database abstraction reference manual, department guidelines, and applicable HIPPA regulations. Half of the position responsibilities will involve providing leadership for functional group leaders for the execution of all monitoring services according to the project specific scope of work. This position will also have over site on the coordination of any faculty and field team launched to regional training and further QI needs once implementation is started at the sites and the field direct implementation budget for Project Leader with minimal guidance. Participate in the development of the protocol/operations manual, revisions to the operations manual as new research emerges or evidenced based clinical guidelines are updated. Participate and oversee survey hospital QI survey tool and information from the faculty mentors strategic site visit, and the training site personnel regarding the discharge and follow up direct intervention and implementation project. Manage monitoring the QI direct intervention site plan and scope of work. Follow established guidelines in the collection of clinical and process data and/or administration of CONNECT HF project. Coordinate and ensure documentation for the administration and monitoring the project including performing site routine monitoring of the entry of data into CONNECT HF registry, process and outcomes data for the project. Oversee and participate in identified opportunities for individual site quality improvement changes identified through CONNECT registry data reports; and along with PI(s), mentorship faculty, and hospital leadership help to improve processes for improvement and measured in next data harvest.; travel as required in the United States. Oversee site initiation visits for the purpose of strategic assessment, regional train the trainers, CONNECT HF education on the disease state and the protocol, study procedures, and importantly monitor the integral communication between all hospital team members on individual outcomes, ongoing performance measurement and feedback and overall management. Position will serve as key direct intervention site management trial team member to internal and external partners and to the project core team (project leader, principal investigator, and other functional group key representatives). Position will collaborate with outcomes operations administration to identify and oversee education and implementation of CONNECT HF outcomes trial related training and performance concerns of monitoring team members according to their individual needs; maintain awareness of level of performance and training needs;provide ongoing input to senior direct intervention outcomes trial leaders for development of individual training plan. Supervise and manage monitoring trial-team member's adherence to regulatory policies with guidance. Encourage team members to attend appropriate training and meetings. Support the department mission, goals and organizational activities. Position reports to a Project Leader/Group Director as a line manager and for daily activities. Position typically leads the monitoring team composed on clinical research associates I, II, and III and Senior Staff for all Outcomes Trials activities through startup, enrollments, closeout and archiving. However, in this study, the CRA 3 coordinates the management of the trainers for the site implementation teams along with the faculty and the mentoring coaches. Perform other related duties incidental to the work described herein for CONNECT HF PL or Directors (faculty and staff).

Requisition Number
401333651

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1459 CLINICAL RESEARCH ASSOCIATE III

Job Family Level
86

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 Pharmacist plus three years of 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 five years healthcare experience; or 2.Completion of a master's degree in Public Health,., Health Administration or a related area with. two years directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a Minimum of three years directly related experience in clinical trials research; or
4. Completion of a bachelor's degree plus a minimum of four years closely related research experience.

**State of North Carolina license 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

93998BR

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.

PI99695093