o Mission: Improving Lives by Providing Advanced Therapeutic Options

o Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research.

o Values:

o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions.

o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues.

o Solution Oriented: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions.

o Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards.

o Physicians are the Vanguard

o All Decisions Improve Patient Care

o Never Compromise Quality

-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.

-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.

· 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.