Clinical Research Site Manager

3 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

oMission:Ensure that every patient has access to innovative treatments and improve patient lives.

oVision:The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.

oValues:

oCompassion:Honor the patient-physician relationship above all else.

oEfficiency:Accountable for outcomes and strive for process perfection.

oProgress:Contribute to continued innovation in medicine while improving health outcomes.

oIntegrity: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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