Summary: Join us at Eximia Research Network as we continue to grow, the Clinical Research Site Manager is responsible for the management of study team and the overall coordination and successful execution of all aspects of the assigned clinical trial(s) in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.

Key Responsibilities

Essential Job Duties: Responsible for the management, oversight, training, and support of assigned clinical study team, and the overall coordination and successful execution of assigned clinical trials. Responsibilities may include but are not limited to:

• Organizing and managing project timelines, milestones, and critical study activities to ensure project deliverables are on time and within budget. Provides regular updates to leadership as appropriate.
• Assisting all needed activities for study start-up, including required training, uploading / printing certificates to file in ISF, etc.
• Coordinating and executing vendor selection and management - manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work.
• Coordinating study activities to support milestone achievement and to manage study issues and obstacles.
• Under the direction of the Site Director and the Principal/Sub Investigators, may assist team in conducting all or any the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP/GDP/ALCOAC, ICH regulations and guidelines:
• Screening of patients for study enrollment; conducting patient consents; conducting patient follow-up visits; obtaining vital signs and ECGs/EKGs;
• Documenting in source clinic charts; Entering data in EDC and answers queries; Updating and maintaining logs, chart filings;
• May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
• Requesting and tracking medical record requests; Maintaining & ordering study specific supplies;
• Conducting monitoring visits and resolves issues as needed in a timely manner;
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
• Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events;
• Coordinating problem solving and resolution efforts to include management of risk, contingencies, and issues. Work closely with leadership to improve and streamline clinic processes.
• Troubleshoot and resolve clinic, protocol, and SOP issues and advise CRCs.
• Participating in people management activities for direct reporting line, including interviewing and selection, performance appraisals, job description preparation, employee counseling and termination meetings, with support from Site Leader(s).
• Mentoring and training personnel in study protocols, processes and requirements, and any relevant applicable regulations, ICH-GCP Guidelines, etc.
• Interpreting regulatory guidelines to educate staff on operational activities for complex studies.
• Facilitating project closure including identifying lessons learned; effectively incorporating lessons learned into future projects; successful transition from project to production for all aspects and team members; appropriately manages project Developing, implementing and delivering training curriculum needed for departmental team. Train new and current Clinical Research Coordinators and Research Assistants to ensure effective coordination of training activities in the clinical trials processes.
• May set up, train and maintain all technology needed for studies.
• Facilitating project meetings and coordinates the interaction with other departments and stakeholder groups.
• Supporting quality initiatives to ensure patient safety.
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed.
• May assist in the development of study-related documentation, including informed consent forms, source and IRB/IEC submissions and renewals.
• May assist with study recruitment, patient enrollment, and tracking as needed.
• Reporting non-compliance to appropriate management in timely manner.
• Maintaining positive and effective communication with clients and team members.
• Maintaining advanced therapeutic area knowledge.
• Maintaining confidentiality of patients, customers and company information.
• Performing all other duties as requested or assigned.