Clinical Research Site Manager (Munster, IN)*

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