Description
Kelly® Science & Clinical is seeking a Clinical Research Sub-Investigator for a fulltime, direct hire position with a research site client in the Denver Metro area.. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
- Sub–Investigator
- Onsite in Wheat Ridge, CO
- ASAP need
- $120,000-$145,000
KEY FUNCTIONS AND RESPONSIBILITIES
The Sub-Investigator is a critical member of the study team as a mid-level practitioner responsible for providing medical guidance and management. The Sub-Investigator provides direct leadership, training, and oversight to site staff including study coordinators and research assistants. The Sub-Investigator overseas the care of study subjects under the guidance of the Principle Investigator.
The Sub-Investigator takes an active role in the Company's growth objectives. The Sub-Investigator supports the development of new client relationships and the strengthening of existing account relationships with a view to expanding the Company's portfolio of investigators, studies, clients and therapeutic area experience and expertise. The Sub-Investigator also assists in building and managing positive relationships in the clinical research community to increase the Company's visibility, reputation, and stature consistent with being a recognized employer and partner of choice.
Responsibilities of Sub-Investigator
• Ensure PI provides sufficient oversight to meet ICH GCP requirements and the expectations of Company's clients including sponsors and CROs.
• Ensure PI conducts study related activities and procedures as required of the PI according to ICH GCPs and sponsor requirements.
• Ensure enrollment expectations and commitments are met or exceeded.
• Participate in clinical studies according to ICH GCPs for sub-Investigators, ensuring adequate time and resources are available, as described in study protocols.
• Clinically evaluate study participants, answer their medical questions, and resolve medical issues, related to the clinical trial during study visits.
• Maintain records of each subject's participation, which includes a review of participants' past and current medical records, to be compared with visit medical history, concomitant medication and protocol inclusion and exclusion criteria.
• Determine participant's eligibility for the study.
• Assess subjects' response to therapy and subject compliance with use of the study drug at follow-up visits
• Administer study drug.
• Evaluate treatment of subjects for adverse events and reporting of all such events to the PI.
• Monitor use of concomitant therapy as authorized by the study protocol.
• Ensure that study drugs and devices are used for protocol purposes only.
• Provide leadership in identifying new clinical trials and assist in initiation of new trials.
• Play an active role in the recruitment of patients to designated studies, while ensuring that subject recruitment is conducted ethically and efficiently.
• Participate in pre-screening recruitment initiatives and activities for clinical trials participants, including presentations to healthcare professionals, public screening clinics, etc., as required.
• Liaises communication with PI's, clinic staff, sponsor, sponsor representatives and vendors.
• Comprehensive understanding of the informed consent process and protocol so that proper written informed consent from each subject is received prior to participation in the study.
• Actively participate in audits and monitoring visits.
• Completion of all administrative tasks for patient files according to ICH GCP guidelines and best clinical practice.
• All other Sub-I duties as assigned or required by study protocol, regulatory agencies, sponsor or CRO.
Qualifications/Education
• Licensed Physician Assistant or Nurse Practitioner with at least 2 years' experience preferred
• Clinical research experience required
• Experience using a Clinical Trials Management System preferred. Demonstrated knowledge of Good Clinical Practice and ICH, and other site-specific regulations preferred
• Excellent interpersonal, verbal, and written communication skills, attention to detail, organizational and prioritizing skills, and time management skills required
• Proficient with PCs and Microsoft Office applications
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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