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.

 

-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.

• This role is performed on-site at a clinical or office facility and requires prolonged periods of sitting, standing, or walking throughout the work environment 
• Requires the ability to communicate clearly in verbal and written forms and to read and interpret detailed materials
• Must be able to navigate a clinical facility, including areas with limited space, and transport supplies or work materials as needed
• May be required to wear personal protective equipment (PPE) in accordance with facility protocols
• Travel between company sites, meetings, or partner locations may be required
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role