Sr. Clinical Research Coordinator - Phase One
Job location: Miami, FL
Employment Type: Full-time
Posted data: 2019-04-26
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DUTIES & RESPONSIBILITIES:
Assist Principal Investigator and Sr. Manager with assessing feasibility.
Organizes and participates in Study Initiation Visits (SIV) in collaboration with the
Attends site disease group tumor board meetings and site disease group collaborative meetings.
Works directly and communicates with SDG Leader and Sr. Managers to meet SDG goals; maintains SDG protocol portfolio with assistance from CRS leadership and tracks accruals for SDG.
Participates in the orientation, mentoring, and coaching including Jr. Clinical Research Coordinator and Data Coordinator. Identifies educational opportunities for members of disease cluster and ensures coverage for attendance when necessary.
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.
Review patient data with the PI to determine patient eligibility for protocol enrollment. Ensure all eligibility forms are completed and submitted for appropriate review.
Assists PI in obtaining informed consent and document the informed consent process. Enter required information in Velos.
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.
Participates in quarterly peer-review, quality control program.
Determine data to be collected and develop forms for collecting/summarizing data. Work with the Data Coordinator to 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.
Execute the plan developed for procurement of protocol specific subject specimens, i.e. pharmacokinetics, tissue procurement as necessary and ensures it is successfully completed.
Assists the Study Team that protocol lab kits and study specific supplies are obtained as required.
Ensure protocol specific data is entered into Velos.
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 IRB/Sponsor. Actively participates in monitoring visits/site audits, etc.
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.
Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
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.
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.
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.
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.
Other duties as assigned.
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.
Job duties will include, but not be limited to:
“Job descriptions are not intended, and should not be constructed to be exhaustive list 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:
Sr. Clinical Research Coordinator who is a Certified Clinical Research Coordinator/CCRC via ACRP and/or SOCRA. Bachelors’ degree required. If the applicant is not certified, applicant must be willing to obtain CCRC certification after 1 year of employment. Five years’ work related experience in Clinical Research required. Prior experience supervising/leading a team and setting team priorities and goals. 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 timeEmployee Type:StaffPay Grade:r7