Clinical Research Coordinator 2
Clinical Research Coordinator 2
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Job Description
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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work at the UHealth Medical campus in Miami Fl
CORE JOB SUMMARY
The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning coordinating implementing monitoring and evaluating of specific clinical research studies. This role assists in the
day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with
study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols help with study-related administrative tasks facilitate across-the-board flow of information and
coordinate study activities and personnel.
CORE JOB FUNCTIONS
1. Assists in participant recruitment and retention activities and assists in screening potential study participants for
eligibility.
2. Performs study procedures routine tests data collection/recording and daily operations of moderate risk clinical
research protocols.
3. Collects processes packs and ships specimens according to protocol applicable standards and regulations.
4. Maintains study binders and filings according to protocol requirements UM and department policy.
5. Distributes study drug materials according to practice standards and clinical credentials as delegated by the
Principal Investigator.
6. Monitors documents reports and follows-up on study unanticipated/adverse events and protocol deviations.
7. Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
8. Assists with study orientation and protocol related in-services to research team and clinical staff.
9. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress;
submits progress reports according to established schedule.
10. Learns the research team and assists with communications/interactions with sponsor data coordinating centers
compliance monitors collaborators investigators academic administrative personnel and departments.
11. Assists in administrative tasks of study personnel including orientation documenting core competencies
certification mandates safety/responsible conduct of research education and performance reviews.
12. Adheres to cultural competency guidelines; implements strategies to meet study participants needs for language
translation health literacy etc.
13. Follows the appropriate fundamental requirements of all international national and local regulatory bodies.
14. Maintains requisite skills and mandatory training in safety equality responsible conduct of research continuing
education and research competencies.
15. Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education:
Bachelors degree in relevant field required
Experience:
Minimum 2 years of relevant experience
Knowledge Skills and Attitudes:
Skill in completing assignments accurately and with attention to detail.
Ability to analyze organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work evenings nights and weekends as necessary.
Commitment to the Universitys core values.
Ability to work independently and/or in a collaborative environment
DEPARTMENT SPECIFICS
- Assists the Monitors and PIs in the organization and preparation of Site Initiation Visits (SIV) and in providing the patients and their families with a thorough description of the research protocol.
- Attends site disease group tumor board meetings and site disease group collaborative meetings.
- Assures that all protocol revisions informed consents continuing reviews serious adverse events are submitted to the appropriate IRB of record in a timely manner.
- Compiles patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment. Ensures eligibility forms are completed as required.
- Assists PI in obtaining informed consent and documents the informed consent process as required. Enters required protocol enrollment report to CRIS Office and JHS CTO according to established procedures. Complete sand submits to the CRIS Office and/or JHS CTO Office protocol specific forms as required per UM and/or JHS policies.
- Ensures study protocol adherence including completion of protocol specific procedures and the completion of protocol specific documents while obtaining relevant medical information from patient clinic charts/medical records.
- Maintains /logs progress reports to track both currently enrolled as well as follow-up participants.
- Provides protocol specific study documentation required in the management of study patients as per the protocol federal regulations sponsor requirements SOPs and UM policies while maintaining logs to track progress reports to both currently enrolled as well as follow-up participants.
- Enters data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy.
- Execute the plan developed for collection of protocol specific subject specimens i.e. pharmacokinetics samples blood specimen tissue samples etc. as per protocol.
- Ensures that protocol lab kits and study specific supplies are obtained/ordered as necessary.
- Responsible for the entry of and maintenance of the patient calendars. Ensures protocol specific data is entered into Velos.
- Monitors adherence to protocol. Takes action to report and correct deviations or other problems.
- Records and reports AEs SAEs and UPs in compliance with federal regulations the protocol and UM policies to the sponsor and/or IRB as directed by the PI.
- Maintains logs including but not limited to the following: screening enrollment adverse event deviation tumor measurement concomitant medication delegation and other sponsor and/or protocol specific logs and actively participates in monitoring visits and site audits.
- Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies the protocol ICH-GCP and federal regulations.
- Establishes and maintains contact with patients/participants health care providers community agencies study sponsors. Updates appropriate agencies such as sponsors IRB etc. regarding current status of research projects as required and under the supervision of the PI.
- Updates SCCC Business Office staff as requested about patient accruals/completed cycles for billing of Industry Studies and for calculation of RVUs for in-house studies and provides support with study related procedures as required i.e. EKG laboratory and tumor assessment studies.
- Ensures timely IRB submissions of initial protocol continuing reports amendments IND safety reports AEs SAEs UP deviations etc. with support from the Sr. Regulatory Specialist.
- Communicates all IRB and Sponsor related approvals changes information etc. to the PI and study team and adapts to physician schedules to perform protocol specific patient visits and/or procedures including but not limited to early AM and /or early evening hours as required.
- Participates in a collaborative empowered work environment as demonstrated through teamwork and ensures work environment is organized and functions efficiently.
- Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center and provides coverage for other CRS SDGs as needed.
- Other duties as assigned.
Minimum Qualifications (Essential Requirements):
- BS degree in science health care or related field; preferred. A minimum of 2-3 years effective work-related experience in research clinical settings hospitals etc. or study coordination is required. 6 years as Clinical Research Coordinator in lieu of Degree. High-level interpersonal skills are required. Excellent English oral and written communication skills and strong computer skills are required.
- Knowledge of medical terminology.
- Ability to manage multiple tasks simultaneously.
- Attention to detail & accuracy.
- Applicant must be willing to obtain a research related certification within 2 years of employment.
#LI-YC1
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealth-University of Miami Health System South Floridas only university-based health system provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center we are proud to serve South Florida Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching research and patient care. Were the challenge youve been looking for.
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:
A9Required Experience:
IC
Employment Type
Full-Time
