The Clinical Research Manager is responsible for the coordination and administration of clinical trials under the direction of the Principal Investigator. They are responsible for overseeing all Clinical Research staff and ensuring compliance with established regulations and standards.

Responsibilities And Duties

• Work to build the research department in scope, size, reputation, and professionalism. 
• Assist with recruitment of studies, review protocols, perform feasibility, budget evaluation and negotiation, clinical trial negotiation along with General Counsel, and communication with study sponsors. 
• Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc. Provide relevant updates to other research staff as applicable. 
• Responsible for maintenance of accurate and complete documentation, including but not limited to regulatory documents, signed informed consent forms, relevant IRB approvals, source documentation, drug dispensing logs, subject logs, and study-related communications. 
• Work with other research department staff in a leadership role including management, training, delegation of responsibilities, hiring, reviews, etc. 
• Design, implement, and manage system for organizing, planning, and controlling workflow related to all clinical research activities. 
• Work with the EMR and data management systems to complete/monitor completion of EDC, eCRFs, adverse event documentation, maintain patient records, create strategies for patient recruitment. 
• Must have or gain knowledge of relevant software/programs, including CTMS. 
• Have in-depth knowledge of trial/protocol design, study end points, statistical methods, etc. 
• Identify and promptly reports protocol deviations, AEs, and SAEs in accordance with protocol, IRB, and/or sponsor requirements 
• Work closely with IRB, study sponsors, PIs and Sub-Is. Attend necessary meetings and calls. 
• Provide continuous communication on study conduct, pre-study through post-study to all relevant stakeholders, including internal communication regarding enrollment, progress, and completion of trials. 
• Maintain study budgets and monitor invoicing, billing, and payments, in collaboration with the accounting department to ensure timely and accurate A/R process. 
• Create, review, and maintain department SOPs, NDAs, CVs, certifications, etc. 
• Evaluate, purchase, maintain necessary equipment and equipment monitoring. 
• Participate in site visits, SIVs, monitoring, etc. 
• Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, procedure visits, etc. 
• Complete necessary study close-out steps and documentation. 
• Prepares for and participates in FDA inspections. 
• Communicate with and support patients and their families as necessary. 
• Maintain HIPAA compliant communication and confidentiality, at all times. 
• Assist with other duties assigned.

Qualifications and Skills : 

• Must have ≥ 10 yrs experience with conducting clinical trials. 
• Urology based clinical experience highly preferred. 
• Bachelor’s degree in a health or science field preferred. 
• Certification via CCRP or CCRC or the equivalent may be considered in lieu of degree. 
• Experience with evaluating and implementing study protocols and budgets. 
• Must have knowledge of and experience with relevant federal and state regulatory guidelines 
• Proficiency in computer software including Microsoft Office Suite, EMR, Practice Management, Electronic Data Capture (EDC), and Clinical Trail Management Systems (CTMS). 
• Exceptional time management skills and the ability to prioritize work. 
• Excellent communication skills and the ability to interact with all levels of management, staff, sponsors, and providers.