Essential Job functions

Performance Expectation: Exhibit proficient and expert competencies required to conduct clinical research
Develops an internationally accepted standard of knowledge and understanding of the research process and related regulations;
Maintains CCRC certification;
Maintains membership in a minimum of 2 (or combination of 2) professional organizations, hospital committees or high-profile activities;
Maintains an advanced level of knowledge including anatomy, disease process, medical terminology, tests and procedures relating to area of responsibility;
Receives a minimum of 36 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 workflow as related to specific activities with meticulous attention to detail and ordering of priorities; and
Functions independently and proficiently as defined in the position essential functions with minimal supervision.

Performance Expectation: Initiates studies
Oversees operationalizing of investigator-initiated and/or NIH clinical trials;
Managers and/or fully participates in design of study-specific research processes;
Coordinates and facilitates site visits;
Assists in evaluation of all potential clinical research studies;
Exhibits a expert knowledge of protocols, including background, rationale and description of investigational drug/device;
Understands and conveys knowledge of inclusion/exclusion criteria, 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
Oversees project enrollment patterns and goals in conjunction with Principal Investigator;
Diligently screens for patients in appropriate departments and participating physician offices;
Completes and submits screening forms as directed;
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 and/or manages orders of all protocol required labs, tests, procedures and medications accurately and according to 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;
Maintains screening and enrollment logs and provides to sponsor within established timeframe; and
Communicates regularly with PI, research nurse, and RCII team to ensure smooth and accurate enrollments.

Performance Expectation: Collects data
Designs project-specific case report forms;
Oversees timeliness and quality of project-specific data collection;
Designs and/or assists in the design of protocols and reports;
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;
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; and
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 and/or manages orders of 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;
Ensures all data is entered on case report forms;
Provides source documentation for all data;
Ensures organized, complete study charts, including legible, accurate research notes; and
Is available to monitor for clarification and corrections as needed.

Performance Expectation: Communication and Problem-Solving
Anticipates obstacles and proactively developing solutions to achieve identified goals;
Is effective as primary source for troubleshooting study-specific obstacles and barriers;
Effectively collaborates with Principal Investigator to address barriers to project success;
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: Miscellaneous Responsibilities
Attends research meetings (e.g., staff, Scientific Review, Protocol Review. etc.);
Prepares agenda(s) and/or manages 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;
Trains and mentors new CRCs;
Oversees day-to-day clinical operations in absence of a Team Lead;
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;
Plans and designs 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 or presentation per year that impact clinical research at VCU Health/VCU; and
Conducts independent research project(s) with goal of publication or conference presentation.

Patient Population: N/A

Employment Qualifications

Required Education:

Bachelor's degree in Health-related Field

Licensure/Certification Required:None

Licensure/Certification Preferred:
Certified CRC (CCRC) certification

Experience Required:
Minimum of five (5) years of clinical research experience

Experience Preferred:
Over eight (8) years of work experience in clinical research;
Eight (8) years of work experience in disease/discipline;
Extensive patient records review and abstraction experience;
Over eight (8) years of work experience in a team environment;
Publication experience;
Protocol development experience; and
Management of clinical 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.