Clinical Research Coordinator I

TIDEWATER PHYSICIANS MULTISPECIALTY GROUP P C•Newport News, VA

About The Position

The Clinical Research Coordinator I conducts clinical research in accordance with ethical, regulatory, and protocol requirements. The coordinator reviews study protocols, assesses prospective participants, explains studies and obtains informed consent, enrolls and schedules participants, coordinates study equipment and supplies, and supports medication or device dispensing and specimen handling. The role collects and maintains study data and records, follows up with participants, monitors compliance, supports audits, and coordinates with investigators, sponsors, healthcare professionals, and institutional review boards. The coordinator also supports participant recruitment, study budgets and billing, training and quality assurance, and preparation of reports and presentations. The position requires familiarity with electronic medical records and HIPAA, organization amid interruptions and multiple records, and the ability to work independently and collaboratively. Some sponsor-related travel and overnight stays may be required. The coordinator may use their own transportation to purchase dry ice and deliver specimen shipments, and may perform work-related tasks off-site. Compensation starts at $52,243 per year; final annual salary depends on the candidate’s relevant experience and qualifications. The position is located in Newport News, Virginia.

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/or boards of directors.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to manage multiple and 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, algebra, and geometry to practical situations.
Legible handwriting.
Current driver’s license and reliable vehicle.
Ability to learn new tasks and apply skills and knowledge to varied work activities.
Ability to work independently and as part of a team.
Ability to stand and walk for long periods and sit for extended periods.
Ability to climb or balance for limited periods; occasionally reach, bend, stoop, and lift up to 50 pounds; and grasp and hold up to 25 pounds.
Ability to hear normal-voice communications in person or by telephone, speak clearly and understandably, taste and smell, and look at a computer screen for many hours.

Nice To Haves

Patient care experience is highly desired.
Phlebotomy experience is desired but not required.
Good Clinical Practice (GCP) certification is desired but not required.
International Air Transport Association (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 the design of proposed and implemented studies and review protocols for processes, data management plans, and potential participant risks.
Communicate with patients, caregivers, medical personnel, research sponsors, and institutional review boards.
Screen potential participants and assess eligibility using interviews, medical records, and discussions with physicians and nurses.
Explain study design, risks, and expected outcomes to patients and caregivers; enroll participants and obtain and document informed consent.
Organize study sites, equipment, and supplies, and coordinate with industry representatives to ensure necessary equipment and software are available.
Attend sponsor-required meetings; travel and overnight stays may be required.
Schedule participants for appointments, procedures, or inpatient stays required by study protocols.
Order study drugs or devices; dispense them, calculate dosages, and provide patient instructions as needed.
Handle, process, label, store, and ship laboratory specimens, including completing requisitions and working with dry ice.
Collect and maintain electronic and/or printed study data, obtain follow-up information, and communicate with participants and healthcare providers.
Register protocol participants 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 participant enrollment and dropout reasons, and document participant contact efforts.
Become familiar with relevant electronic medical records and HIPAA requirements.
Monitor studies for compliance with protocol design, applicable regulations, and TPMG ethical policies.
Prepare for and participate in audits by sponsors, federal agencies, and designated review groups.
Coordinate sponsor site visits and respond to questions about records or data.
Identify protocol problems, inform investigators, and assist with resolution.
Work with healthcare professionals to identify recruitment practices; develop recruitment advertising and informational 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.
Review scientific literature and pursue continuing education or attend conferences and seminars to maintain current knowledge.
Use personal transportation to purchase dry ice and deliver laboratory specimen shipments through USPS, UPS, or FedEx as needed.
Perform other duties as assigned.