Clinical Research Site Manager

Profound Research·Munster, IN

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About the role

On-site, full-time Clinical Research Site Manager role in Munster, Indiana. Responsibilities include clinical trial compliance, site and staff management, training, enrollment planning, CRC duties, quality improvement and CAPA work, recruitment partnerships, and stakeholder liaison activities. Requires an associate degree or BS/BA in Life Sciences or a related discipline, 8+ years as a clinical research coordinator, and 3–5 years of direct line management experience. GCP or CCRC certification is preferred.

Key requirements

• Associate degree or BS / BA in Life Sciences or related discipline.
• At least 8 years of relevant experience
• Required skills: Clinical research coordination, Clinical trial site compliance, FDA regulations, ICH-GCP guidelines, SOP and protocol compliance, Staff supervision and performance management, Staff training and inspection readiness, Enrollment planning, Clinical assessments, Vital signs, EKGs, Blood draws, Laboratory specimen processing and shipping, CAPA development, Patient recruitment, Stakeholder communication, Teamwork, Organization, Regional travel

Opportunity details

• Workplace: On Site
• Posted: Jan 29, 2025
• Original advert language: English

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Employer’s role description

Job title: Clinical Research Site Manager (Munster, IN)

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.

Clinical Research Site Manager

About the role

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