Additional Info

1. Maintains regulatory documents and case report forms accurately in compliance with FDA guidelines. (E)
2. Interacts with research pharmacists to maintain adequate supplies and records of investigational drugs. (E)
3. Coordinates the collection, processing and distribution of laboratory samples to labs as designated. (E)
4. Assists principal investigator with adverse event reporting.
5. Assist investigators with development and implementation of research protocols.
6. Coordinate and facilitate training for staff participating on research protocols and maintaining appropriate and up to date documentation for this training.
7. Point of contact for after hour notification of research protocol needs and reporting (24/7 for inpatient subjects).
8. Brief companies with our screening and enrollment conditions and accomplishments to establish a partnership to attract future trials.

1. Performs research procedures associated with clinical research including assessment and evaluation of patient needs. Coordinates patient care & participation in investigational protocols under the principal investigator#s direction for compliance with investigational protocols. Facilitates the process of informed consent and enrollment of the patient to the study. (E)
2. Educates participants about the study including the daily requirements and informs of possible effects and outcomes. (E)
3. Plans and coordinates the patient evaluation of candidates for protocols. Coordinates study patient#s visits, laboratory and clinic appointments to ensure that procedures are performed according to protocol. (E)
4. Serves as primary contact for assigned research trials. Provide direct care under the principal investigator#s direction for participants in compliance with investigational protocols. Foster collegial relationships and provide assistance to all investigators in clinical trials. (E)
5. Evaluates progress of each research trial and reports weekly to that Principal Investigator. (D)
6. Acts as a contact for staff & patients and follows specific patients in clinic in conjunction with physicians as assigned. (E)
7. Fields and triages patient#s questions and phone calls. (E)
8. Contributes to research efforts of the division by identifying or collaborating on research projects, participating in data evaluation, and applying pertinent research to the clinical practice. (E)
9. Coordinate cardiovascular medicine clinical investigations to include data management, participant identification and recruitment, with a working knowledge of federal, state, and UNMC regulations governing clinical research. (E).
10. Monitor patient laboratory work. (E)
11. Coordinates medical refills and authorizations. (E)
12. Interacts with patients, referring physician#s offices, and clinic scheduling personnel to optimize scheduling. Schedules follow up visits as needed. (E)
13. Ensures that referring physicians receive timely and adequate medical information. (E)
Other study coordination duties as assigned. (E)

1. Maintains complete and confidential patient files on each participant. (E)
2. Completes surveys, database information and/or case report forms in a timely manner with high degree of accuracy. (E)

1. Educates patients, their families, health care professionals, community organizations and the general public aimed at recruitment of research subjects and general awareness of medical issues related to patient needs.
2. Assists in establishing and implementing medication education for patients. (E)
3. Instructs patients in basic prevention programs. (E)

1. Demonstrate knowledge and skill in addressing age-specific needs of patients served. (E)
2. Continually works to improve knowledge in clinical area by attending continuing education programs and reviewing literature. (E)
3.Attend investigator meetings to network with other coordinators at sites also conducting the studies.
4. Maintain BLS, ACLS, CITI, GCP certifications.

Cardiovascular Clinical Research Operations Administrator, Direct, Daily

No

NA

Office,Clinical

Full extent of working environments TBD by position activities.

Adult (18-65 years),Geriatric (65 and older)

Full extent of activity TBD by position activities.

Full extent of Lift/Carry/Push/Pull Activity TBD by position activities.

Full extent of exposure TBD by position activities.

Full extent of Protective Equipment TBD by position activities.

Full extent of Hands/Wrist TBD by position activities.

Campus Essential,Department Essential,If needed, could the employee work from home during an emergency condition?:Yes