Clinical Research Site Manager

4 weeks ago

Oceanside, United States Profound Research LLC Full time

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 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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