Clinical Research Sub-Investigator (Detroit, MI)*
Profound Research
Detroit, MI, USA
Posted on Oct 9, 2024
The Company
Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available.
Mission, Vision, Values
o Mission: Ensure that every patient has access to innovative treatments and improve patient lives.
o Vision: The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.
o Values:
o Compassion: Honor the patient-physician relationship above all else.
o Efficiency: Accountable for outcomes and strive for process perfection.
o Progress: Contribute to continued innovation in medicine while improving health outcomes.
o Integrity: Hold ourselves to the highest ethical, quality, and scientific standards in every activity
Profound Ethos
• Physicians are the Vanguard
• All Decisions Improve Patient Care
• Never Compromise Quality
Why this Role Exists
A member of the clinical trial team designated and supervised by the principal investigator (PI). The job of the Sub Investigator (Sub-I) is to act as the secondary physician in medical and clinical issues, as requested or required. The Sub-I works with the PI to evaluate clinical trials and ensure that all study- related procedures are completed. The Sub-I performs critical trial-related procedures and makes important trial-related decisions. The Sub-I is engaged in the informed consent process and has a significant role in the conduct of the research.
Responsibilities
Conduct Patient Visits
· Conduct clinical examinations.
· Perform phlebotomy and process blood and urine samples.
Ensure Patient Safety and Medical Oversight
· Obtain informed consent of each human subject to whom the drug is administered in accordance with the provisions of Title 21 part 50 except as provided in Title 21 part 50.23 and 50.24. Title 21 part 312.60.
· Sign prescriptions where applicable
· Supervise administration of study drug.
· Observe, measure and record effects of drug.
· Evaluate, manage and report all adverse events.
· Performs technical tasks, such as medical procedures, tests and assessments that require special experience.
· Participate actively in all phases of the research study including serious adverse event (SAE) reporting and advocates for all patients.
· Provide accurate history and physical examination to all research subjects at baseline including all the required phase for each study.
· Process and package various infectious and non-infectious lab specimens.
· Work with the clinical research coordinator in providing in-service education on new protocols to study and clinic/hospital staff as needed.
· Oversee that coordinator is knowledgeable and educated on study drug administration.
· Assist in maintaining accurate accountabilities for all clinical supplies received by the site.
· Assist and educate staff on phlebotomy.
· Ensure accurate screening logs are sent to sponsor weekly by coordinator.
Support Enrollment and Retention
· Screen and recruit patients.
· Confirm eligibility of study subjects.
Support Trial Conduct
· Ensure that an investigation is conducted according to the signed investigator statement, the investigational plan and the applicable regulations.
Evaluate laboratory and other medical reports.
· Maintain accurate accountabilities for all clinical supplies received by site.
· Keep and make study documentation available for data verification purposes.
· Assess study-specific procedures along with the clinical research coordinator required for each protocol and assign responsibility to specific staff.
· Responsible for study completion (study close-out).
· Send accurate screening logs to sponsor weekly.
· Be available for any questions regarding closeout visit of study.
· Perform other duties as assigned.
Requirements
· Nurse practitioner, physician's assistant, or medical doctor.
· Trained and experienced in clinical research.
· Familiar with the background of the study drug and requirements of the study.
· Have high ethical standards and professional honesty.
· Friendly and outgoing demeanor.
· Must demonstrate a passion for direct patient interaction.
· Demonstrate clinical competence, positive leadership and ability to work collaboratively with a multi-disciplinary team.
· Regular and punctual attendance.
Travel Requirements
· Daily commute to site(s)
· Occasional travel may be required in this position (less than 1 month per year)
Physical Requirements
· Prolonged periods of sitting at a desk and working on a computer, standing and walking.
· Must be able to lift 25 pounds at times.
· Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
· Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
· Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
· The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.