Clinical Research Site Manager (Munster, IN)

Profound Research•Detroit, MI

10h

About The Position

Profound Research: Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research. Our Mission: Improving Lives by Providing Advanced Therapeutic Options Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research Our Values: Compassion : We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. Urgency : We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. Solution Orientation : We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. 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 . Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o 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

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.

Nice To Haves

Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred.

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.