Clinical Research Site Manager

Dermatology practice in North Miami Beach is seeking an experienced Clinical Research Site Manager!

The Clinical Research Manager has the responsibility and accountability for daily functions and overarching management of the clinical study. This includes but is not limited to the following:

• Ability to manage multiple clinical research trials and ensure quality research conduct from study activation to study closure


• Manage communications with the CRO, subcontractors, and Sponsor


• Serves as an expert resource to coordinators in large scale and or multiple protocol clinical research studies


• Serve as a resource to facilitate development and implementation of tools, plans, and strategies to manage clinical trial portfolio and all monitoring activities

Support Study Start Up & Recruitment Activities

• Responsible for submissions of study-specific regulatory documentation and review with IRB


• Works with sponsors to develop an adequate budget for clinical trials, ensuring that the site is being compensated correctly for all clinical related procedures. Works with the finance, legal and risk team to negotiate budget and contracts


• Ensure staff trainings and certifications are updated,


• Supports Recruitment, based on capacity, location, and individual site capabilities

Study Conduct & Close Out Activities

• Manage study timelines to remain on schedule with deliverables and mitigate risk.


• Works with study team to follow protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and implements corrective actions as appropriate


• Maintain system and study specific trackers to ensure on-time milestone completion and project milestones (enrollment goals, database lock timelines, etc.) met in a timely manner


• Develop and present project status reports to leadership and Sponsors/CROs


• Escalate any risks to the Management and prepare mitigation plans to ensure project meet goals and objectives of the contract


• Manage vendor relationships and communications to ensure smooth delivery of clinical trial services


• Work with Finance team to support invoicing and resolve any billing inquiries


• Liaise with Procurement and Site operations to ensure required infrastructure is in place and maintained for clinical trial activities and procure supplies as needed


• Liaise with Quality and Partners for collaboration, performance, and quality of clinical trials


• Ensure site and study close out procedures are followed and arrange for data and documentation archive and storage


• Train and Mentor new study managers and coordinators and provide training as necessary


• Quality & Regulatory Oversight


• Oversee adherence to SOPs, Good Clinical Practice (GCP), FDA, and HIPAA regulations for all clinical trial staff members


• Manage audits and monitoring visits across all clinical trials

Protected Health Information

• Adheres to and supports all federal regulations and university policies and procedures instituted to safeguard protected health information (PHI)


• Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with federal regulations and sponsoring agency policies and procedures. Assists PI to assure that all personnel complete appropriate training


• Cooperates with company compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office


• Performs other duties as assigned by management

Required

• At least 3-5 years relevant experience in site based clinical research


• In-depth knowledge clinical trials and principles of Good Clinical Practices (GCP), protocol and study-specific operating procedures, consent forms, and study schedules


• Excellent written and verbal communication skills


• Superior interpersonal, organizational, problem solving and time management skills


• Capable of working independently with minimal supervision and high attention to detail.


• Skilled with standard computer programs including the MS Office suit Effective skills in using MS Windows and Office applications such as Access, Outlook, Excel, and Word


• Understanding of medical terminology as well as standard clinical procedures and protocols