Job location: Campus - UHealth/Miller School of Medicine

Employment Type: Full-time
Posted data: 2018-11-28
Req: R100017913

Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.

Where Excellence Meets Purpose

The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.

With more than 16,000 faculty and staff, the University strives for excellence, and is driven by a powerful purpose to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value.  Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.

The University has been named on Forbes's Best Employers list for two consecutive years, and is the only university in Florida to receive this honor.

JOB DUTIES & RESPONSIBLITIES:

1. Member of Team (Clinical Manager[s], Team Leader [s], QA Manager, and Principal Investigator) that design and develop protocols and determine feasibility.

2. Member of Team (Clinical Manager[s], Team Leader [s], QA Manager, and Principal Investigator) that prepares protocol documentation and packages for SCCC Protocol Review Committee (PRC) review, including development of Informed Consent Forms, Investigator Brochures, etc.

3. Organizes and participates in Study Initiation Visits (SIV) in collaboration with the Clinical Manager(s), Team Leader(s) and Education Manager.

4. Attends site disease group tumor board meetings and site disease group collaborative meetings.

5. Works with Clinical Manager to evaluate and adjust CRCs workloads.

6. Works directly and communicates with SDG Leader and Clinical Managers to meet SDG goals; maintains SDG protocol portfolio with assistance from CRS leadership and tracks accruals for SDG.

7. Collaborates and works with direct reports to resolve personnel issues. Conducts performance appraisals of staff using feedback from others where applicable. Participates in the mentoring, coaching and disciplinary process of team personnel and firing process of team personnel.   Identifies educational opportunities for members of disease cluster and ensures coverage for attendance when necessary.     

8. Provide patient and staff education (in-services) regarding all Site Disease Group (SDG) specific protocols. Assist the PI in providing the patient and his/her family with a thorough description of the treatment and possible side effects related to study treatments. 

9. Review patient data with the PI to determine patient eligibility for protocol enrollment. Ensure all eligibility forms are completed and submitted for appropriate review.

10. Assists PI in obtaining informed consent and document the informed consent process. Enter required information in Velos.

11. Report protocol enrollment to CRIS Office and JHS according to established procedures. Complete and submit to the CRIS Office and/or JHS CTO Office protocol specific forms as required per UM and/or JHS policies.

12. Ensure study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents.  Obtain relevant medical information from patient clinic charts/medical records.  Maintain logs/progress reports to track both currently enrolled as well as follow-up participants.  Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy.

13. Determine data to be collected and develop forms for collecting/summarizing data.  Enter data onto case report forms and/or into computer database as appropriate.  Complete corrections/queries required at audits/monitor visits.  Ensure data integrity and consistency in computer database and written records.

14. Execute the plan developed for procurement of protocol specific subject specimens, i.e. pharmacokinetics, tissue procurement as necessary and ensures it is successfully completed.

15. Assists the Clinical Team Leader that protocol lab kits and study specific supplies are obtained as required.

16. Responsible for the entry of and maintenance of the patient calendar. Ensure protocol specific data is entered into Velos.

17. Monitor participant adherence to protocol.  Take action to report and correct deviations or other problems.  Verify accuracy of research data and monitor data quality control.  Record serious adverse events, etc. in compliance with applicable regulations and report to Quality Assurance.  Actively participates in monitoring visits/site audits, etc.

18. Promptly reports side effects of treatment to the Investigator and ensures Regulatory is provided accurate information to report to IRB. In turn, ensures appropriate patient follow up is performed and follow up safety reports are completed and provided to Regulatory as required per HSRO policies, protocol specific requirements, GCP, and the federal regulations.

19. Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.

20. Ensure that randomization and registration of patients entered onto Cancer Center sponsored clinical trials are performed in compliance with CRS and UM policies, the protocol, GCP, and the federal regulations.

21. Establish/maintain contact with patients/participants, health care providers, community agencies, study sponsors.  Update appropriate agencies (such as sponsors, regulatory, etc.) regarding current status of research projects. 

22. Update Business Office staff as requested about patient accruals/completed cycles for billing of Industry studies and for calculation of RVUs for in-house studies.

23. Provide support in relation to the performing of study related procedures as required, i.e. EKG, laboratory and tumor assessment studies.

24. Adapt to physician schedules to perform protocol specific visits and/or procedures including, but not limited to early AM and/or early evening hours as required.

25. Ensures work environment is organized and functions efficiently.  Participates in a collaborative, empowered work environment as demonstrated through teamwork.  Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center. Provide coverage for other CRS SDGs as needed.

26. Engage in continuing education of research policies/guidelines. Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure, and/or keep abreast of latest trends in field of expertise.

27. Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures.  Follows established UM and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.  Practices a high level of integrity and honesty in maintaining confidentiality.

28. Other duties as assigned.

a. Job descriptions are not intended, and should not be construed to be exhaustive lists of all responsibilities, skills, efforts or working conditions associated with a job.  Management reserves the right to revise duties as needed.

KNOWLEDGE, SKILLS, and ABILITIES:

• Knowledge of medical terminology as well as the ability to read identify and extract pertinent data from medical records.

• Computer skills that include MS office

• Need the ability to manage multiple tasks simultaneously and independently.

Work Experience Requirements (Essential Requirements):

• Minimum five (5) years of Clinical Research Experience required.

• Prior experience Supervising/leading a team.

• Must have experience setting team priorities and goals.

EDUCATION & EXPERIENCE:

Bachelors’ degree required and 5 years work related experience in a clinical setting. Prior experience supervising/leading a team and setting team priorities and goals preferred.  Must be able to work independently and collaborate with a team, must have experience conducting quality control audits and data analysis/entry.  Computer skills related to data management required.   Excellent skills in English (both verbal and written) required.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:

Full time

Employee Type:

Staff

Pay Grade:

r7