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
- Mission: Ensure that every patient has access to innovative treatments and improve patient lives.
- Vision: The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.
- Values:
- Compassion: Honor the patient-physician relationship above all else.
- Efficiency: Accountable for outcomes and strive for process perfection.
- Progress: Contribute to continued innovation in medicine while improving health outcomes.
- 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
Role & Responsibilities:
- Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
- Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
- Responsible for immediate supervision and performance of the assigned site including conducting performance reviews as well as coaching, counseling, and implementing disciplinary action if needed.
- Responsible for ensuring appropriate training of all staff to ensure compliance and inspection readiness.
- Work closely with Operations and Business Development leadership on feasibility and study placement.
- Accountable for enrollment planning and success at sites across all studies; understand revenue expectations.
- Coordinate as primary CRC on at least one trial of medium to high complexity and serve as a back-up CRC for other study procedures and trials when needed. This includes completing all relevant training in a continued timely manner.
- Share best practices with other Profound site locations with the goal of raising the overall level of operational competencies at Profound.
- Work closely with the Quality Assurance team to ensure quality at the site; create processes and CAPAs to improve trends as needed.
- Identify and build relationships with outside medical practices, pharmacies, and other healthcare professionals/organizations to aid in the patient recruitment process.
- Act as a site liaison and champion by communicating effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
- Ensure weekly, monthly, and quarterly assigned goals are met for the respective sites.
- In addition to trial specific responsibilities, support in building and implementing a scalable operations infrastructure at new, regional Profound Research sites as needed.
- Other duties as assigned by leadership.
Requirements & Skills:
- Associate degree or BS / BA in Life Sciences or related discipline.
- 8+ years prior experience as a clinical research coordinator.
- 3-5 years of direct line management responsibilities.
- Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred.
- Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens.
- Demonstrated ability to foster concepts of teamwork, cooperation, self-control, and flexibility to get the work done.
- Excellent attention to detail, organization, and communication with varied stakeholders.
- Able to travel regionally and to professional meetings as required.
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.
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