Clinical Research CoordinatorSr Clinical Research Coordinator SOM Internal Medicine

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCUs sponsored research the School of Medicine is internationally recognized for patient care and education. VCU School of Medicine comprises 18 clinical departments eight basic health science departments and 11 affiliated institutes and centers and provides preeminent education to physicians and scientists in order to improve the quality of healthcare for humanity. All fulltime university staff are eligible for our generous benefits package that includes choices for health vision and dental coverage lifeinsurance short and longterm disability coverage retirement planning taxdeferred annuity and cash match programs flexible spending accounts tuition benefits significant paidtime off12 paid holidays and more. Explore our benefits further here: Summary:

This position will function as a clinical research coordinator within theDepartment of Internal Medicine providing support across our 11 divisions. In this role theincumbent will work alongside a team focused on supporting the research effortsof investigators across multiple specialties.

Forall clinical research studies assigned the Clinical Research Coordinator isresponsible for coordinating clinical research activities in a compliant andefficient manner from study initiation to close out. Under the direction of thePrincipal Investigator (PI) collaborates with all members of the clinicalresearch team to ensure all federal state university and protocolrequirements are followed institutional research objectives are met and thatethical obligations are kept. Core responsibilities are listed below along withother tasks and duties as assigned.

CoreResponsibilities:

20: General/Administrative

For assigned studies coordinate clinical research processes and documentation which may include: filing and office organization research participant scheduling ordering of study materials and supplies and schedule of meetings.
Coordinate and/or prepare and collect all necessary study documentation which may include: feasibility forms prescreening logs screening logs enrollment logs medication log adverse event log delegation of authority log training logs etc.

Design and implement optimal systems to identify potential research subjects for assigned studies.
Support the orientation and training of new research team members and other staff.
Follow all university and School of Medicine procedures for activation and management of clinical research.
As requested provide financial staff with information/data to aid in financial management activities.

20: Regulatory & Compliance Requirements

Understand and adhere 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.
On behalf of Principal Investigators (PI) prepare RAMSIRB (and central IRBs as applicable) submissions including: initial continuing amendments safety reports serious adverse event reporting

Participate in meetings with internal and sponsor appointment monitors to ensure accuracy of subject data and compliance with research protocol and regulatory requirements.

Coordinate auditing and monitoring activities for assigned studies.

10: New Study Activation
Schedule site selection visits.
Coordinate site selection visits and study selection activities for assigned studies.
Ensure OnCore tasklist data entry is complete for all studies assigned; keeping study team task lists current throughout the activation process.
Participate in SOM study activation activities and followup action items. Coordinate with study PIs to provide information to support development/finalization of coverage analysis and budget documents; time/effort estimates billing plan assessment etc.

20: Study Conduct
Coordinate subject recruitment activities: prescreening screening.
Access allowable data capture/retrieval systems and interact with a variety of health care delivery system to identify potential study participants.
Conduct informed consent process for research participants under PI supervision.
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.
Support the PI and other senior study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements.
Work with PI to ensure all required study closeout activities are completed.

20: Data Management & Documentation

Assist the PI and senior study team members in the management of study data for new and ongoing clinical research studies assigned.
Maintain study files according to GCP guidelines and in audit ready condition.
For assigned studies ensure subject data is entered into sponsor case report forms databases and VCUs OnCore system in a timely manner and in accordance with sponsor and university/school level requirements.
Review and respond to all sponsor query replies within required time frames seeking input from PIs and other study staff as appropriate.

10: Clinical Skills

Complete VCUHS orientation and training modules as required for the department & clinical research projects. Conduct applicable clinical activities only as approved & required for each clinical research project.
Must maintain all required VCU and VCUHS competencies related to performing research related clinical skills.
Cannot perform any tasks that by state or local law require a license to perform unless such license is on file and approved by VCU/VCUHS.

Minimum Hiring Standards:

Bachelors degree or equivalent combination of education training with at least 1 year of experience in a clinical research role.
Active license or ability to obtain CNA CMA or EMT within 6 months of hire date.
Excellent communication writing and interpersonal skills.
Ability to read interpret and apply complex regulations policies and requirements for each study assigned.
Excellent organization time management and critical thinking skills.
Able to manage complex clinical trials including those enrolling participants with highacuity healthcare needs.

Demonstrated experience working in and fostering an environment of respect professionalism and civility with a population of faculty staff and students from various backgrounds and experiences or commitment to do so as a staff member at VCU.

Preferred Qualifications:

Demonstrated knowledge and understanding of clinical research management to include: regulatory human subjects protection study conduct and data management requirements.
Clinical Research Coordinator certification (CCRC CCRP CCRA)
Familiarity with EPICand VCU Health System.

Additional Information:

ORP Eligible: NO
Hours / weeks 40 hours weekly
Title Details: Clinical Research Coordinator
UNIVERSITY JOB CODE: Clinical Research Coordinator RSN34113N)/Sr. Clinical Research Coordinator RSN34116N)
University Code: 34111N34116N)

University Job Family: Research & Innovation

The position will remain open until a candidate is selected.

This is a restricted position with no set end date and continued employment is dependent upon project needs availability of funds and performance.

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.

Demetria Patterson

Required Experience:

Senior IC