Clinical Research Coordinator, School of Medicine - Richmond, United States - State of Virginia

Description

Summary

This position is responsible for the organization, logistics, and implementation of assigned research

projects conducted by the Department of Neurosurgery, including subject recruitment/management,

data collection and reporting, regulatory compliance, and other study-related duties as assigned.

Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical

Research Coordinator, plus additional sponsor GCP certifications as required.

Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all

aspects of IRB approved protocols.

Conduct all assigned activities in compliance with national, local, & institutional guidelines,

according to all HIPAA, GCP, and other applicable requirements


Activities include coordinating:
new study activation requirements, screening/enrolling participants, regulatory and compliance

requirements, maintaining appropriate study documentation/records, and managing study data.

Duties and Responsibilities

Data Management and Documentation

o Documents/ensures entry of subject screening/enrollment, visits and study procedures

for billing, and eCRF data

o Maintain study files according to GCP guidelines and in audit ready condition

o For assigned studies, ensure subject data is entered into sponsor case report forms,

databases, and VCU's OnCore system in a timely manner and in accordance with

sponsor and university/school-level requirements.

o Review and respond to all sponsor query replies within required timeframes, seeking

input from PIs and other study staff as appropriate.

Regulatory and Compliance Requirements

o Performs/monitors study activities to ensure adherence to all human subject protection

and IRB regulations required for clinical research. Understand duty to report obligations

related to research conduct, and the appropriate university channels for reporting

concerns.

o Familiar with IRB (and WIRB, as applicable) to be able to assist with submissions

including:
initial, continuing, amendments, safety reports, serious adverse event

reporting.

o Participate in meetings with internal and sponsor appointment monitors to ensure

accuracy of subject data and compliance with research protocol and regulatory

requirements.

o Serves as liaison between investigators, research personnel, clinical staff, sponsors, and

regulatory agencies. Keeps PI and leadership informed regarding study operations and

progress. Identifies problems or trends in their development; notifies and involves

appropriate resources for problem-solving; recommends procedural modifications or

operational improvements and directs implementation and evaluation of these.

Prepares/assists in preparation of reports, presentations, and publications.

o Ensures that study startup, ongoing administration, and closeout activities are carried

out according to sponsor/funding agency requirements as well as all University policies

and procedures. Uses RAMS-IRB effectively for all required approvals and human

subjects' documentation; ensures that study approval remains up-to-date over study

timeline, including close-out/data analysis period. Obtains all required internal

approvals (ie:
SOMCT, OSP, etc.) prior to initiation of study activities and start of subject

enrollment. Organizes study data for required reporting and for audits, either internal or

external. Ensures that final study closeout is completed fully and in a timely manner.

New Study Activation

o Familiar with IRB (and WIRB, as applicable) to be able to assist with submissions

including initial, continuing, amendments, safety reports, serious adverse event

reporting

o Schedule site selection visits

o Coordinate site selection visits and study selection activities for assigned studies.

o Ensure OnCore task list data entry is complete for all studies assigned; keeping study

team task lists current throughout the activation process.

o Participate in SOM pre-study planning meetings and follow-up action items. Coordinate

with study PIs to provide information to support development finalization of coverage

analysis and budget documents; time/effort estimates, billing plan assessments, etc.

o Works with the Oncore Team to ensure that all is set-up and data are correct and meets

the needs of the study, including:
verifies/monitors enrollment logs and study calendar

are accurate; sets up eCRFs using investigator-prepared variable lists for data entry

(investigator-initiated projects only)

o Follow all university and School of Medicine procedures for activation and management

of clinical research.

Study Conduct

o Coordinate subject recruitment activities:
pre-screening, screening

o Access allowable data capture/retrieval systems and interact with a variety of health

care delivery systems to identify potential study participants

o Conduct informed consent process for research participants under PI supervision

o Coordinate the registration and enrollment of participants, coordinate and file

registration/randomization documents; notifying applicable/allowable individuals of

registration/randomization results (PI, participant, study team, pharmacist, etc.)

o Support the PI and other senior study staff in following study participants through all

study activities to ensure the study is conducted in compliance with all requirements

o Work with the PI to ensure all required study close-out activities are completed.

Clinical Skills

o Complete VCUHS orientation and training modules as required for the department and

clinical research projects. Conduct applicable clinical activities only as approved and

required for each clinical research project.

o Any clinical skills must be conducted in VCUHS approved clinical areas only. Any protocol

required clinical skills requires current VCUHS competency verification/documentation

prior to performing each activity.

o Must maintain all required VCU and VCUHS competencies related to performing

research related clinical skills

o Cannot perform any task that by state or local law requires a license to perform, unless

such license is on file and approved by VCU/VCUHS.

o Will serve as liaison between investigators, research personnel, clinical staff, sponsors,

and regulatory agencies

o Keeps PI and leadership informed regarding study operations and progress

o Identifies problems or trends early in their development; notifies and involves

appropriate resources for problem-solving; recommends procedural modification or

operations improvements and directs implementation and evaluation of these.

o Prepares/assists in preparation of reports, presentations, and publications

Contributes to the Research Mission of the Department of Neurosurgery

o Participates in and contributes to research-related activities of the Department ie:

Grand Rounds, educational sessions, etc.

o Keep PI and leadership informed regarding study operations and progress

Essential Qualifications

Must have a minimum of 1-3 years of relevant clinical and clinical research experience.

Significant years clinical experience with relevant study population

Clinical research experience required

Sound knowledge of computers including web-based applications and stand-alone software (i.e.

Microsoft Word and Excel particularly useful)

Able to work successfully in a complex environment, excellent interpersonal and communication

skills, outstanding problem-solving ability, and flexibility to handle multiple tasks and deadline

pressures

Must be able to work in a diverse environment

Able to work evenings and/or weekends, if needed

Must complete mandatory competencies and certifications required by VCU within designated

timeframes and maintain these through the duration of employment.

Demonstrated experience working in and fostering a diverse faculty, staff, and student

environment or commitment to do so as a staff member at VCU.

Preferred Qualifications

Consideration will be given to candidates with extensive clinical background and/or expertise in

related areas (i.e. quality improvement, project administration, data management)

Advanced degree in Nursing or related field desirable

Position will remain open until filled.


ORP Eligible:
No


UNIVERSITY JOB:
Clinical Research Coordinator (Open)

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

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 our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off, 12 paid holidays, and more.

Explore our benefits further here:

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.

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.