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Premier Clinical Research is an independent research company providing pharmaceutical clinical trials in Spokane, WA. We're looking for a Clinical Research Coordinator to join our growing company.

Clinical Research Coordinator is responsible for conducting trials as per the GCP guidelines under the supervision of the Principal Investigator (PI). Although the PI has the overall responsibility for performing the trial, it has been stated that the CRC is the heart and soul of the clinical trial and that, eventually, it is the CRC who carries ahead the research objectives, in that way playing an important role in the success of the clinical trial. Most significantly, CRCs are usually engaged in vital duties that have been usually carried out by the PI, some of them being the informed consent process and making sure that the site staff is in compliance with the protocol. The CRC's main responsibility, as with all clinical research staff, is to ensure the protection and well-being of the patients participating in the study.

In addition, a CRC has many other duties which include:

• Take part in preparation and control of research budgets and financial payments.
• Notify subjects regarding all study aspects relevant to them.
• Keep track of study activities to make sure compliance with protocols and with all related local, state, and national regulatory and institutional polices.
• Manage necessary records of study related activity which includes case report forms, drug dispensation records etc.
• Obtain industry-sponsored studies via personal contacts and professional organizations.
• Direct the request, collection, labeling, storage, or shipment of samples.
• Take part in meetings and seminars to update knowledge of clinical research and related issues.
• Enroll subjects in the study as per the study protocol.
• Prepare or get involved in quality assurance audits performed by study sponsors, regulatory authorities, or exclusively designated review groups.
• Prepare advertising and other educational materials and conduct campaigns to enroll subjects.
• Consult with health care experts to figure out the best recruitment practices for clinical trials.
• Monitor enrollment status of participants and record dropout details such as dropout causes and subject contact efforts.
• Overview proposed study protocols to assess factors such as sample collection procedures, data management issues, and possible subject threats.
• Record adverse event and side effect information and consult with investigators concerning the reporting of events to regulatory agencies.
• Prepare trial-related paperwork such as protocol worksheets, adverse event reports, IRB documents, procedural manuals and progress reports.
• Manage subject registration to make sure that informed consent is effectively obtained and recorded.
• Keep in touch with sponsors to schedule and coordinate site visits or to answer queries.
• Dispense study medical devices or drugs to subjects, determine dosages and deliver instructions as necessary.
• Complete all Central IRB submissions as applicable
• Learn and adhere to all trial Protocol and SOP guidance.

Required Qualifications/Experience:

At least 1 year of previous experience in sponsored clinical research (CRC certification preferred).

Must work independently as well as being a team-player.

Attention to detail, FDA knowledge, IRB oversight and strong organizational skills are required.

Basic computer skills in Word, Excel, and other electronic data management/scheduling/electronic medical records

Hands-on participant/patient experience and specimen

MA-P/CMA preferred

Clinical Research Coordinator Certification, preferred

Must be moral and ethical in decision-making and during interactions with patients, s