Clinical Research Site Manager (Detroit, MI)*

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.