Clinical Research Coordinator I

Tidewater Physicians Multispecialty Group P C•Newport News, VA

About The Position

The Clinical Research Coordinator I conducts high-quality clinical research in accordance with ethical and regulatory standards. The role supports clinical studies from protocol review and participant recruitment through enrollment, study visits, specimen handling, data collection, documentation, monitoring, and close coordination with investigators, patients, caregivers, health care providers, sponsors, and institutional review boards. The coordinator helps ensure that studies follow their protocols and applicable federal, state, and local requirements, and assists with audits, budgets, billing, training, and quality assurance. The position may involve attending sponsor meetings with some travel and overnight stays, performing work off-site, purchasing dry ice using personal transportation, and delivering specimen shipments through USPS, UPS, or FedEx. The coordinator must manage multiple responsibilities and interruptions while maintaining organized, accurate study records.

Requirements

Bachelor’s degree from a four-year college or university, one to two years of related experience and/or training, or an equivalent combination of education and experience.
Knowledge of appropriate medical terminology, email etiquette, effective communication, and clinical study affairs and issues.
Ability to work scheduled hours and use time effectively.
Ability to determine an appropriate course of action in complex situations.
Ability to present information effectively to top management, public groups, and boards of directors.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to manage multiple simultaneous responsibilities and refocus after interruptions.
Ability to read and understand oral and written instructions and follow written protocols.
Ability to manage data, prepare spreadsheets, and apply mathematical concepts including probability, statistical inference, and basic algebra and geometry.
Ability to work independently and as part of a team, remain organized, and learn and apply new tasks, skills, and knowledge.
Legible handwriting.
Current driver’s license and reliable vehicle.
Ability to stand and walk for long periods, sit for extended periods, and climb or balance for limited periods.
Ability to occasionally reach, bend, stoop, and lift up to 50 pounds, and to grasp and hold up to 25 pounds.
Ability to hear normal-level communications in person or by telephone, speak clearly and understandably, taste and smell, and look at a computer screen for many hours of the day.

Nice To Haves

Patient care experience is highly desired.
Phlebotomy experience is desired but not required.
GCP certification is desired but not required.
IATA certification is desired but not required.
Certification by the Association of Clinical Research Professionals (ACRP) or a similar organization is preferred but not required.

Responsibilities

Become familiar with proposed and implemented study designs and review protocols, including sample collection processes, data management plans, and potential risks to participants.
Communicate with patients, caregivers, medical personnel, research sponsors, and institutional review boards.
Screen potential participants by conducting interviews, reviewing medical records, and discussing patient status with physicians and nurses.
Explain study designs, risks, and expected outcomes to patients and caregivers.
Organize study sites, equipment, and supplies, and contact industry representatives to ensure needed equipment and software are available.
Attend sponsor-required meetings; travel and overnight stays may be required.
Enroll participants and obtain and document informed consent in accordance with applicable regulatory and ethical requirements.
Schedule participants for appointments, procedures, or inpatient stays required by study protocols.
Order study drugs or devices; dispense medications or devices, calculate dosages, and provide patient instructions as needed.
Handle, process, label, document, store, and ship laboratory specimens, including working with dry ice.
Collect and maintain electronic and/or printed study data, obtain follow-up information, and communicate with participants and health care providers as needed.
Register protocol patients with statistical centers when required.
Prepare and maintain case report forms, drug dispensation records, regulatory records, protocol worksheets, procedural manuals, adverse-event reports, IRB documents, and progress reports.
Record adverse events and side effects and consult investigators about reporting them to oversight agencies.
Collaborate with investigators on reports and presentations about study procedures, results, and conclusions.
Track enrollment, document participant dropouts and reasons, and record efforts to contact participants.
Become familiar with relevant electronic medical records and HIPAA requirements.
Monitor studies for compliance with study protocols, applicable regulations, and TPMG ethical policies.
Prepare for and participate in audits conducted by sponsors, federal agencies, and designated review groups.
Coordinate sponsor site visits, maintain sponsor contact, and respond to questions about records or data.
Identify protocol problems, inform investigators, and assist with resolving issues.
Consult health care professionals about recruitment practices, develop recruitment materials, and meet with physician groups as needed.
Participate in research budget preparation and management, study billing, and oversight of monetary disbursements.
Participate in training and quality assurance programs.
Maintain current knowledge of clinical study affairs through literature review, continuing education, conferences, and seminars.
Use personal transportation to purchase dry ice and deliver laboratory specimen packages to USPS, UPS, or FedEx as needed.
Perform work-related tasks off-site when necessary and undertake other duties as assigned.