Clinical Research Coordinator I

Tidewater Physicians Multispecialty Group P C•Newport News, VA

3d•Onsite

About The Position

The Clinical Research Coordinator I conducts high-quality clinical research following the highest ethical and regulatory standards of care. This is a part-time position with a typical schedule of Monday through Thursday, either 7:00 AM–1:00 PM or 8:00 AM–2:00 PM. The schedule is flexible and can be discussed based on availability. The role involves becoming familiar with study designs, reviewing protocols, communicating with various stakeholders, assessing patient eligibility, informing patients and caregivers about study details, organizing study sites, ordering supplies, attending sponsor meetings, enrolling patients, scheduling appointments, ordering and dispensing study medications/devices, handling and processing laboratory specimens, collecting and maintaining study data, obtaining subject follow-up information, registering patients, preparing and maintaining study records, recording adverse events, collaborating on reports, tracking enrollment, understanding electronic medical records and HIPAA, monitoring study compliance, preparing for audits, maintaining sponsor contact, identifying and resolving protocol problems, conferring with healthcare professionals on recruitment, developing recruitment materials, meeting with physician groups, participating in research budget preparation and management, assisting with billing processes, participating in training and quality assurance, and reviewing scientific literature to maintain current knowledge.

Requirements

Knowledge of appropriate medical terminology.
Knowledge of appropriate email etiquette and effective communication.
Knowledge of clinical study affairs and issues.
Ability to work scheduled hours as defined in the job offer and to use time effectively.
Ability to determine appropriate course of action in more complex situations.
Ability to present information to top management, public groups, and/or boards of directors effectively.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to manage multiple and simultaneous responsibilities.
Ability to read and understand oral and written instructions and follow written protocols.
Ability to manage data, prepare spread sheets, and apply mathematical concepts such as probability, statistical inference, and basic concepts of algebra and geometry to practical situations.
Bachelor’s degree from a four-year college or university.
One to two years related experience and/or training, or equivalent combination of education and experience.
Legible handwriting is a requirement.
Current driver’s license and reliable vehicle.
Ability to learn new tasks and apply skills and knowledge to various work activities.

Nice To Haves

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

Responsibilities

Become familiar with the design of proposed and implemented studies.
Review study protocols to evaluate factors such as sample collection processes, data management plans, and potential risks to subject patients.
Communicate well with patients, medical personnel, research sponsors, and institutional review boards (IRBs).
Assess eligibility of potential subjects through screening interviews, review of medical records, and discussion of patient status with physicians and nurses.
Inform patients and caregivers of study designs, risks, and outcomes to be expected.
Organize sites for study equipment and supplies.
Contact industry representatives to ensure that the equipment and software specifications needed for successful study completion are available.
Attend meetings required by research sponsors; some travel and overnight stays may be required.
Enroll patients in clinical studies, ensuring that informed consent is obtained and documented in accordance with all applicable regulatory and ethical requirements at the federal, state, and local levels.
Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
Order the drugs and/or devices necessary for studies.
Dispense medication and/or medical devices, calculate dosages, and provide instruction for patients as necessary.
Handle lab specimens which may include blood, urine, vaginal fluids, joint aspirants, sputum or others.
Process, label specimen tubes, fill out requisitions, work with dry ice, store and ship lab specimens as required.
Collect and maintain study data, which may be either electronic and/or printed, depending on the study.
Obtain subject follow-up information and communicate with health care providers and subjects as necessary.
Register protocol patients with appropriate statistical centers as required.
Prepare and maintain records of study activities, including case report forms, drug dispensation records, and regulatory compliance.
Prepare and maintain study-related protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Record adverse events and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Collaborate with investigators to prepare reports and presentations concerning clinical study procedures, results, and conclusions.
Track enrollment status of subjects, document causes of dropout, and document efforts to contact subjects.
Become familiar with relevant electronic medical records and HIPAA law.
Monitor studies to ensure compliance with protocol design.
Monitor studies to ensure compliance with federal, state and local regulations and TPMG's ethical policies.
Prepare for and participate in audits conducted by study sponsors, federal agencies, and specifically designated review groups.
Maintain contact with sponsors to schedule and coordinate site visits and answer questions about all issues with records or data.
Identify protocol problems, inform investigators of problems, and assist resolution of such problems.
Confer with health care professionals to determine the best recruitment practices for studies.
Develop advertising and other informational materials to be used in subject recruitment.
Meet with physician groups as needed.
Participate in preparation and management of research budgets.
Participate in the billing process for studies and oversee monetary disbursements.
Participate in training and quality assurance programs.
Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical study affairs and issues.
Work well independently and with a team.
Refocus attention easily after multiple interruptions.
Remain organized despite multiple paper charts being utilized at the same time.
Use own transportation to purchase dry ice for laboratory specimen shipments and take packages to USPS, UPS, and/or FedEx for delivery as needed.
Perform work-related tasks off-site when necessary.
Willing and eager to learn new things.
Other duties as assigned.