Clinical Research Site Manager (Munster, IN)

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 & Work Environment  
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  
Why Join Profound Research?