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
Seniority level
Not Applicable
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Hospitals and Health Care
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