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Eximia Research · 2 weeks ago

Principal Investigator- Des Moines

Iowa, United States

Part-time

Onsite

Lead/Staff

Eximia Research is a fully Integrated research sites network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). The Principal Investigator is responsible for the execution, planning, and management of assigned studies, ensuring participant safety and data integrity at the trial site.

BiotechnologyClinical TrialsTherapeutics

Responsibilities

Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice

Provide medical expertise and scientific feasibility for new sponsor inquiries

Ensure that the safety and well-being of all participants in the study at the trial site are protected

Ensure data collected at the study site is credible and accurate

Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected

Assist and provide guidance to clinical operations, research staff, and to sponsor client managers as required

Obtain and/or review participants' medical history

Perform physical assessments, examinations and study procedures as required by study protocols

Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs and lab work

Immediately report Serious Adverse Events (SAEs)-or any abnormalities affecting participants' safety-to sponsors and to the IRB as required by study specific reporting guidelines

Oversee the administration of Investigational Product

Review and adhere to study protocol

Maintain proper documentation

Ensure accuracy, completeness, legibility, and timeliness of data reported and be consistent with source documents

Prior to starting a study and while a study is ongoing, ensure that the study, clinical trial protocol, informed consent form, recruitment materials, and other documents provided to the subject are approved by the IRB and comply with GCP (Good Clinical Practices) and other regulatory requirements as required

Ensure that the IRB is provided with a copy of the Investigator's brochure, product monograph, or information about the product or intervention to be studied so the IRB can fully assess the risks involved

During the study, ensure the IRB is informed of any changes to the protocol, Investigator's brochure (or other safety information about the product/intervention), protocol deviations, or unanticipated problems

Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator's brochure/product monograph and other documents provided by the sponsor

Be aware and comply with ICH GCP (International Conference on Harmonization - Good Clinical Practice) and all applicable regulatory requirements

Maintain trial documents as specified by guidelines and applicable regulatory requirements

Ensure retention of essential documents until at least two years after the last approval of a marketing application or at least two years since formal discontinuation of the investigational product

Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies

Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities

Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason

Inform and provide a detailed written explanation of the termination/suspension of the trial to the IRB and, if the investigator terminates the trial without prior agreement, to the study sponsor

Qualification

Clinical research experienceM.DD.OMedical licenseBoard certificationClinical Practice (GCP)

Required

PREVIOUS RESEARCH EXPERIENCE IS REQUIRED

Previous clinical research experience is required

Minimum qualifications include an M.D or D.O with an active medical license (medical license must be valid in the state in which the research is conducted)

Must have previous research experience

Board certification or board eligibility in a specialty appropriate to the type of research being conducted at the site

Medical licensure (license must be valid in the state in which the research is conducted)