Jobs and Careers
CA
Sub-Investigator (w/Infusion)
Care AccessUnited Statesfull_timeVerifiedPosted 2 Aug 2024
💰 $2,147,483,647/yr
About the role
What We DoCare Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We AreWe care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position OverviewThe Sub-Investigator II will be responsible for regional travel mixed with remote tele-medicine work to support our clinical research studies. Additionally, our Sub-Investigator II’s will be skilled in administering investigational products (IV, SC, TD, IM, PO administration), performing physical examinations, monitoring for investigational product related reactions, among other duties beyond the standard clinical research Sub-Investigator role. Care Access is looking for highly motivated Nurse Practitioners or Physician’s Assistants to support clinical trial related activities in states throughout the USA. What You'll Be Working OnDuties include but not limited to:● Work closely with the Principal Investigator to oversee the execution of study protocols, delegating study related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines, and other state and local regulations as applicable. ● Attends and participates in meetings with the director, other managers, and staff as necessary.● Complies with regulatory requirements, policies, procedures, and standards of practice. ● Read and understand the informed consent form, protocol, and investigator's brochure. ● Be available to see subjects virtually or in-person as dictated by project design, answer their questions, and resolve medical issues during the study visit. ● Sign and ensure that the study documentation for each study visit is completed. ● Perform all study responsibilities in compliance with the IRB approved protocol. ● Administration of Investigational Products (via subcutaneous, transdermal, intramuscular, intravenous, or oral routes). ● Proficiency in starting, monitoring, and maintaining intravenous lines.● Proficiency in phlebotomy, proper blood collection practices, and laboratory processing practices (can be learned) ● Contribute as an active member of clinicians involved in the management of infusion or other investigational product related reactions. ● Maintain a clean, efficient clinical area to assure the highest standards of patient care. ● Follow safety and PPE procedures as well as maintain proper documentation of infusion procedures. ● Timely communications with internal teams, investigators, review boards, and study subjects● Perform trial procedures as per delegation which can include the following but not limited to: ○ Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment. ○ Obtain informed consent per SOP. ○ Administer delegated study questionnaires, as appropriate. ○ Collect and evaluate medical records. ○ Complete visit procedures and ensure proper specimen collection, processing, and shipment in accordance with protocol. ○ Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. ○ Review screening documentation and approves subjects for admission to study. ○ Review admission documentation and approves subject for randomization. ○ Provide ongoing assessment of t
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