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Clinical Research Coordinator, School of Medicine / Pediatrics

Employer
Virginia Commonwealth University
Location
Virginia, United States
Salary
Salary Not Specified
Date posted
Sep 15, 2022


Summary

Responsible for overseeing operations of clinical trials and research studies in the VCU Department of Pediatrics (in
collaboration with treating physicians and/or principal/local investigators) by engaging directly with clinical trial
participants and their families, to screen, recruit, and enroll patients into trials and ensures protocol compliance and
communication is maintained throughout the study.

Coordinates the evaluation, treatment and follow-up of clinical trial candidates and participants in inpatient and
ambulatory settings, educating staff at local and partner sites about clinical trials & related patient care and consulting
with local & collaborating physicians & staff about patient care issues.

Maintains study source documents, reports adverse events, and ensures timely data collection. Evaluates, uses, and
refines systems for data collection and collaborates with research team members to ensure data accuracy and integrity.

Collaborates with providers and research team members to facilitate clinical research nursing and ensure regulatory
and data management components of the clinical trial program are maintained.

Collaborates closely with Principal Investigator (PI) and clinical research team to ensure that key federal/state/local
regulatory requirements are followed; that institutional operational research objectives are met; and that ethical
obligations are kept. Creates and submits applications/documents to regulatory authorities (eg., IRB, FDA) and/or
review and monitoring boards.

Develops, establishes, and maintains productive relationships with VCU colleagues, sponsor representatives, external
vendors, and contacts at affiliate sites to achieve essential research outcomes. Facilities monitoring visits and ensures
all ancillary departments are educated and informed about study.

Typical Duties

Risk Management

-- This position will not be directly responsible for creating a budget for clinical projects;
however, this position should have an understanding of the clinical support needs
associated with studies in which he/she is involved and will help to ensure that
project activities adhere to Sponsor supported / funded activities.
-- Expectations are clear, well communicated, and relate to the goals and objectives of
the department or unit.
-- Staff receive frequent, constructive feedback
-- Staff have the necessary knowledge, skills, and abilities to accomplish goals.
-- The requirements of the performance management system are met and evaluations
are completed by established deadlines with proper documentation.
-- Performance issues are addressed and documented as they occur.
-- Safety issues are reviewed and communicated to assure a safe and healthy
workplace.
-- If necessary to handle petty cash, will be required to keep accurate, auditable
records.

Subject Care Coordination

-- Contributes to the implementation of clinical trials and coordination of clinical
management of candidate and enrolled participants.
-- Interviews/screens patients for protocol entry/evaluation.
-- Monitors and documents response to therapy and communicates findings to team/PI
with recommendation for appropriate intervention.
-- Evaluates patients for clinical trial eligibility, identifies appropriate cases and, in
consultation with attending, refers to clinical research staff.
-- Educates protocol patients and families about clinical research and the treatment
that will be given.
-- Ensures that pre-treatment preparation of patients is complete and properly
documented.
-- Interfaces with physicians, nurses, and other disciplines to ensure that treatment,
diagnostic testing and monitoring occurs per protocol and as clinically indicated.
-- Follows patients throughout treatment to ensure that proper data is collected and
quality care is provided.
-- Serves as a resource to patients and families post-discharge and between clinic
visits.

Study Patient Care

-- Provides and documents direct patient care to candidate and participant clinical trial
patients in ambulatory and inpatient settings.
-- Rounds on clinical trial inpatients to assess status; provide support, consultation and
education to patient & providers; ensure that interventions & documentation meet
protocol & quality care standards.
-- Collaborates with providers to develop/implement plans for patient/family/significant
other counseling/education.
-- Participates in multi-disciplinary patient care conferences.
-- Assists and guides nursing staff in ambulatory and inpatient settings in providing
quality care to clinical trial participants and candidates.
-- Facilitates the development of systems which enhance the quality of clinical trialrelated
care delivered to study candidates and participants.
-- Demonstrates ability to acquire new knowledge and skills in order to take on
additional responsibilities, improve current practice and enhance professional
development.

Administrative

-- Designs the optimal system to identify and screen research patients.
-- Designs quality assurance systems to ensure accurate and high quality data
collection practices.
-- Communicates regularly with study chairpersons and others to ensure compliance
with cooperative group expectations.
-- Assists satellite sites in the development of systems to support clinical research in
their setting.
-- Ensures compliance with the federal regulations of the Office for Protection from
Research Risks through ongoing communication with the VCU Committee on the
Conduct of Human Research.
-- Collaborates on the design, implementation and evaluation of computerized systems
for the long-term follow-up of patients.
-- Participates in Hospital and University committees relevant to the area of clinical
research in hematology.
-- Coordinates site visits with pharmaceutical companies; ensures that company files
are in compliance with FDA requirements.
-- Enters all visit data in a timely and accurate manner.

Advanced Practice

-- Collaborates with colleagues to incorporate research findings into practice.
-- Initiates and/or participates in research design, data collection, analysis and writing
for publication.
-- Identifies own learning needs, discusses and implements developmental plan with
immediate supervisor.
-- Serves as an expert leader in a specialty area, serving as a role model to others
within the institution & outside.
-- Participates in activities appropriate to professional goals.
-- Seeks and receives feedback and adjusts behavior accordingly.
-- Functions as patient advocate and encourages patient advocacy.
-- Demonstrates sound judgment, creativity in problem-solving, ability to reach valid
conclusions. Results of work are subject to review but are generally accepted as
accurate & requiring minimal revision.
-- Establishes priorities independently, determines/requests guidance as needed, and
seeks assistance through appropriate channels

Minimum Qualifications

-- Bachelor’s degree or equivalent training and experience in relevant field;
-- A minimum of 2 years of experience working with patients on clinical trials;
-- Ability to work in diverse and demanding environment;
-- Excellent written and oral communication skills;
-- Good clinical practice training and CITI certification;
-- Experience working with / in EPIC;
-- CMA (certified medical assistant), CNA (certified nursing assistant), or EMT (emergency medical technician)
certification and credentials – or – will commit to complete on-the-clock, company-paid training to successfully
receive one of these credentials within 6 months of hire date.

Preferred Qualifications

-- Current CMA, CNA, EMT certification and/or BSN or RN from an accredited school or an equivalent combination of
training and experience;
-- 4 years clinical research experience, with children and families preferred;
-- Current employee who is familiar with VCU and VCUHS processes and systems;
-- Advanced knowledge of FDA regulations and guidelines.

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. All full-time university staff are eligible for VCU’s generous benefits package that includes: competitive health benefits, paid annual and holiday leave, retirement planning and savings options, tax-deferred annuity and cash match programs, Virginia Retirement System (VRS), professional development & certifications, tuition waiver, parental leave, caregiving leave and community service leave. Learn more about VCU’s benefits here: https://hr.vcu.edu/careers-at-vcu/why-work-at-vcu/

Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.

Position will remain open until filled.

ORP Eligible: No

This is a restricted position with no set end date; continued employment is dependent upon project need, availability of funding, and performance.

The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply.

UNIVERITY JOB CODE: Clinical Research Coordinator 1-3 (34111)

Salary Range: $50,000 - $65,000/annually



Position Details:

Department: Pediatrics / 1594
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 1
Exemption Status: Exempt




Contact Information:

Contact Name: Denise Mitchell

Contact Email: denise.mitchell1@vcuhealth.org

Contact Phone:




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