Clinical Research Manager - Syracuse, NY Position Summary: The Clinical Research Manager (CRM) is responsible for managing the full scope of proper study conduct including, but not limited to: protocol development to final report, regulatory filing and/or publications, coordinating cross functional efforts in the administration and progress of Phase 1 to 4 clinical trials. They assist the Principal Investigator with all research activities to include study start-up, conduct and close-out activities in order to achieve program objectives and goals in a timely manner and within budget. The CRM ensures studies are conducted according to the GCP/ICH guidelines, as well as other federal and state regulations. They provide study-specific direction and mentoring to CRC’s, CRA’s and other support staff as appropriate. Essential Duties and Responsibilities: • Independently lead clinical trial project execution to ensure that trial timelines, costs, and quality metrics are met • Serves as primary contact for functional area representatives in managing protocol execution • Supervise the Clinical Research Coordinators • Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments • Create and manage clinical trial budgets and staffing/resourcing plans • Work with outside sources to locate new study opportunities and distribute to proper Investigators interested in doing Research • Collaborates with Investigator on new Clinical Studies and completes the Initial Submission to the Investigator Review Board (IRB) • Coordinates and attends all Pre-Study/Study Site visits with Sponsor and Investigator • Manages the updates of all study regulatory documents such as: Amendments, Continuing Reviews, AE/SAE tracking/reporting, Human Studies Tracking log, training requirements, medical licenses, Curriculum vitae • Meet with Study Monitors when necessary per protocol • Submission and maintenance of sponsor IND safety reports to IRB • Participant screening and randomization as per protocol • Scheduling patient visits • Explain consent and HIPAA process and assist patient in completion of forms before any other study related activity is performed • Collection, processing and shipping of protocol related laboratory specimens • Perform subject interviews and assessments at study visits for data required by protocol • Assess and ensure subject safety through participation of trial • Facilitate study drug dispensing, usage and accountability per protocol • Maintain electronic data capture system per study • Troubleshoot issues that may occur with participants • Manage inventory levels of laboratory supplies and study related materials • Resolve queries that may occur • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration and teamwork General Requirements: I. Guidelines The CRM works very closely with the PI, Executive Director, and patients and must have an excellent understanding of GCP guidelines, laboratory practices, procedures, safety measures and industry standards. While the CRM does not have to personally complete all these objectives they must make sure that all the parts of the research, development, design and implementation are done on the timeline and in the correct manner. II. Complexity The duties of this position require highly developed leadership and organizational skills. In addition, the CRM must exercise sound judgment and the ability to work independently towards general results. The CRM must have proven supervisory skills and the ability to mentor the Clinical Research Staff. A wide variety of duties require the general knowledge of departmental policies and procedures that guides the exercise of judgment and decision making within the specifications of standard practice. Other Conditions • Customer Service - This individual must meet the needs of customers while supporting company missions, consistently communicate and treat customers in a courteous, tactful, and respectful manner, provide the customer with consistent information according to established policies and procedures, and handle conflict and problems in dealing with the customer constructively and appropriately. Qualifications and Requirements: Education: Bachelor’s Degree in a science or medical discipline Experience: 5+ years of clinical research project coordination Specific skills or knowledge: • Team oriented and collaborates effectively with the Clinical Research study team, cross-functional team members, and external partners • Excellent organizational and negotiation skills. Proven ability in creative problem-solving and possess sound judgment • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology • Experience developing clinical plans, e.g. for monitoring, feasibility and site selection, subject recruitment, and clinical supplies management • Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate • Ability to effectively function in stressful situations • Ability to keep information confidential • Ability to set priorities, analyze and resolve problems, and make decisions in a timely fashion Please email resume to careers@carr-recruiting See carr-recruiting for other job openings
Posted on: Thu, 22 May 2014 17:00:50 +0000
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