Essential Job functions
Performance Expectation: 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; and
Proven to function independently and proficiently as defined in the position essential functions with minimal supervision.
Performance Expectation: Initiates studies
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; and
Ensures accurate progress of the protocol from planning to closure.
Performance Expectation: Enrolls patients
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; and
Maintains screening and enrollment logs and provides to sponsor within established timeframe.
Performance Expectation: Collects data
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; and
Processes, stores, and ships biospecimens according to local and study specific requirements.
Performance Expectation: Manages study patient follow-up
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; and
Collaborates with attending physician and principal investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe.
Performance Expectation: Manages monitoring visits
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; and
Is available to monitor for clarification and corrections as needed.
Performance Expectation: Communication and Problem-Solving
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; and
Capable of anticipating obstacles and proactively developing solutions to achieve identified goals.
Performance Expectation: Additional Responsibilities
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; and
Completes one (1) special project a year or presentation per year that impact clinical research at VCU Health/VCU.
Patient Population: N/A
Employment Qualifications
Required Education:
Bachelor’s degree in Health-related Field
Licensure/Certification Required: None
Licensure/Certification Preferred:
Clinical Certification, and maintenance, of one of the following:
Basic Life Support (BLS) training for Healthcare Professionals
Experience Required:
Minimum of two (2) years of clinical research experience
Experience Preferred:
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; and
Experience training research staff.
Cultural Responsiveness:
Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
Working Conditions
Periods of high stress and fluctuating workloads may occur.
General office environment.
Prolonged periods of working alone.
Physical Requirements
Lifting/ Carrying (0-50 lbs.), Push/ Pull (0-50 lbs.), Stoop, Kneel, Squat, Balance, Bending
Work Position: Sitting, Walking, Standing
Additional Physical Requirements/ Hazards
Physical Requirements: Manual dexterity (eye/hand coordination), Finger Dexterity
Hazards: none
Mental/Sensory: Reasoning, Problem solving, Speak clearly, Reading, Logical Thinking
Emotional: Steady pace, Able to handle multiple priorities
EEO Employer/Disabled/Protected Veteran/41 CFR 60-1.4.