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VCU Health · 9 hours ago

Clinical Research Coordinator III

Richmond, VA

Full-time

Onsite

Entry, Mid Level

2+ years exp

VCU Health is a prominent healthcare organization seeking a Clinical Research Coordinator III. This role involves overseeing clinical trials, managing patient enrollment, data collection, and ensuring compliance with research protocols and regulations.

Hospital & Health Care

H1B Sponsor Likely

Responsibilities

Exhibit advanced competencies required to conduct clinical research

Maintains an intermediate knowledge and understanding of the research process and related regulations

Maintains CCRC certification

Maintains membership in one (1) professional organization or hospital committee or high-profile activity

Maintains an intermediate level of knowledge including anatomy, disease process, medical terminology, tests and procedures relating to area of responsibility

Receives a minimum of 24 contact hours per year related to clinical research or job-related discipline documented by certificates of continuing education credits

Exhibits a high skill level of Microsoft Office and enrolls in classes as needed to achieve this level

Exhibits a high level of proficiency in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements

Develops a system for organizing, planning and controlling work-flow as related to specific activities with meticulous attention to detail and ordering of priorities

Proven to function independently and proficiently as defined in the position essential functions with minimal supervision

Coordinates and facilitates site qualification visits

Assists in evaluation of all potential clinical research studies

Exhibits a working knowledge of the protocol, including background, rationale and description of investigational drug/device

Understands inclusion/exclusion criteria

Understands visits, tests, procedures and concomitant medications per protocol

Knowledgeable and confident to perform informed consent process including multiple consenting when appropriate

Maintains communication with sponsor representatives, including acquisition of case report forms, device and/or drug stock, study tools and related documents

Maintains current inventory logs

Identifies study specific tests and procedure protocols, contacts appropriate departments and facilitates required training, certification and validation

Coordinates and facilitates site initiation visits

Assesses protocol requirements for patient care and provides necessary instruction

Collaborates with principal investigator to identify standard of care vs. nonstandard of care visits, hospitalizations, tests and procedures

Assembles, updates and maintains study packets, including consent, inclusion/exclusion check list, sponsor contact information and other related information

Prepares and distributes study specific flyers for ancillary staff and departments

Coordinates in-service/training/proctoring for physicians, departments and appropriate staff with supervision

Ensures accurate progress of the protocol from planning to closure

Diligently screens for patients in appropriate departments and participating physician offices

Completes and submits screening forms

Enters screen failures in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements

Maintains contact with principal investigators and sub-investigators to promote study and encourage patient enrollment

Available and prepared for patient enrollment

Promotes protocol compliance by being in clinic/physician’s office/lab/OR when the subject is seen or leaves guidelines for investigator or sub-investigator to follow

Notifies and schedules sponsor clinicians, engineers and/or proctors for cases as necessary

Orders all protocol required labs, tests, procedures and medications accurately and according to VCU Health/VCU and area of responsibility SOPs

Manages studies prospectively to prevent protocol deviations

Enters patient enrollments and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements

Communicates regularly with PI, research nurse, and RCII team to ensure smooth and accurate enrollments

Maintains screening and enrollment logs and provides to sponsor within established timeframe

Knowledgeable of both electronic and paper case report forms and procedures for completion and correction

Ensures all study documentation is accurately maintained, utilizing sponsor source documents or develops source documents as necessary

Completes case report forms at time of enrollment and at follow-up visits with appropriate source documentation

Returns case report forms to study sponsor in a timely manner

Responds to data clarification requests adequately and in a timely manner

Maintains a log of outstanding queries

Maintains confidentiality of Protected Health Information (PHI) and keeps all records secure

Requests charts and office notes from referring physicians and investigators to retrieve/capture data

Obtains all required signatures in a timely manner

Processes, stores, and ships biospecimens according to local and study specific requirements

Follows study patient both in-patient and out-patient throughout course of study

Meets the timetable for protocol procedures and follow-up schedule

Ensures patient is scheduled for follow-up appointments

Orders all protocol required follow-up labs, tests, procedures and medications accurately and according to area of responsibility SOPs

Is present for all follow-up appointments when possible

Collects appropriate data during follow-up visit utilizing acceptable source documentation

Enters patient follow-up visits and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements

Monitors for adverse events, including daily review of study patient hospitalizations

Informs patients of changes in protocol and adverse events; re-consents patients as required

Makes every attempt to locate patient for follow-up and documents activity appropriately

Collaborates with attending physician and principal investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe

Coordinates and schedules monitoring and study close-out visits

Schedules conference room, principal investigator, regulatory personnel, pharmacist and other staff in advance for sponsor visit

Ensures all data is entered on case report forms

Provides source documentation for all data

Maintains organized, complete study charts, including legible, accurate research notes

Requests and has available all medical records related to study patient

Is available to monitor for clarification and corrections as needed

Effectively shares and educates university and health system staff regarding the process for management of the segregation and routing of charges related to the treatment of patients enrolled in clinical trials

Independently identifies barriers to the segregation process and utilizes appropriate resources to resolve problems and remove barriers

Communicates in a timely professional manner with investigators, research staff, colleagues, and university and health system departments

Answers pages, phone messages and e-mails in a timely manner documenting communication as necessary

Takes the necessary initiative and collaborates with the interdisciplinary team members

Coordinates with research study staff and health system departments to identify and interact efficiently to maximize use of health system resources

Capable of anticipating obstacles and proactively developing solutions to achieve identified goals

Attends research meetings (e.g., staff, Scientific Review, Protocol Review. etc.)

Assists in preparing agenda(s) for research meetings

Participates in continual learning, Performance Improvement (PI) projects and JCAHO Readiness

Functions within the guidelines of VCU Health, VCU, HIPAA, OSHA, JCAHO, federal, state and other regulatory agencies including OPRR, GCP and FDA guidelines

Participates in VCU Health/VCU quality assurance programs

Acts as liaison and "Good Will Ambassador" between research department, physician practices, hospital and staff

Assists in training new CRCs

Ensures all regulatory documents and correspondence are submitted to regulatory personnel in a timely manner

Meets department screening and accrual goals

Assists in recruiting and interviewing potential candidates for research positions

Assists in planning and design of new forms/flowsheets to be used in research activities

Performs other duties as assigned and/or participates in special projects in order to support the mission of clinical research at VCU Health

Provides assistance to team members as needed/requested

Accepts alternate assignments, as required, graciously

Completes one (1) special project a year or presentation per year that impact clinical research at VCU Health/VCU

Qualification

Clinical research experienceCCRC certificationClinical Trial Management SystemMicrosoft Office proficiencyBasic Life Support (BLS)Cultural responsivenessCommunication skillsProblem-solving skillsAttention to detailTeamwork experience

Required

Bachelor's degree in Health-related Field

Minimum of two (2) years of clinical research experience

Maintains CCRC certification

Maintains membership in one (1) professional organization or hospital committee or high-profile activity

Maintains an intermediate level of knowledge including anatomy, disease process, medical terminology, tests and procedures relating to area of responsibility

Receives a minimum of 24 contact hours per year related to clinical research or job-related discipline documented by certificates of continuing education credits

Exhibits a high skill level of Microsoft Office and enrolls in classes as needed to achieve this level

Exhibits a high level of proficiency in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements

Develops a system for organizing, planning and controlling work-flow as related to specific activities with meticulous attention to detail and ordering of priorities

Proven to function independently and proficiently as defined in the position essential functions with minimal supervision

Preferred

Clinical Certification, and maintenance, of one of the following: Certified Medical Assistant, Certified Nursing Assistant, Emergency Medical Technician, Paramedic, or equivalent level of certification

Basic Life Support (BLS) training for Healthcare Professionals

Three (3) years of work experience in clinical research

Five (5) years of work experience in disease/discipline

Significant previous patient records review and abstraction experience

Five (5) years of work experience in a team environment

Experience training research staff

Company

VCU Health

Glassdoor3.6

VCU Medical Center is a school. It is a sub-organization of Virginia Commonwealth University.

Founded in 1838

Richmond, Virginia, USA

10001+ employees

https://www.vcuhealth.org

H1B Sponsorship

VCU Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (29)

2024 (32)

2023 (37)

2022 (45)

2021 (44)

2020 (33)