Non-Clinical Administrative Administration Manager

Clinical Research Manager- Temporary to Permanent. Applicants who are not looking for a permanent role will not be accepted. Required upon hire: ACRP or SOCRA certification or other Clinical Research Certification Education: Bachelors Degree Required Masters Degree Preferred Experience: - 7 years of Clinical research experience REQUIRED - 5 years in management or supervision of clinical trials REQUIRED. - 5 years Experience in clinical research finance REQUIRED - Experience in managing data collection reporting outcomes quality improvement standards/pathways REQUIRED - Experience in meeting FDA (GCP ICH guidelines) as well as other Federal State and Local regulations surrounding human research REQUIRED. - Experience with working with Pharmaceutical and FDA agency representatives REQUIRED. Summary Under the supervision of the Director the Manager of Clinical Research is responsible for assuring the strategic vision directions and operations of the clinical research finance department are implemented and adhered to by all staff. Responsible for oversight of the day to day operations of the clinical research finance team. Responsibilities include compliance with regulations and assure good communication between the various ministries stakeholders and leadership. Assists in developing implementing and maintaining policies and procedures. Assists in providing on-going formal and informal training for research staff. Manage Human Resource functions of the Department including recruitment hiring career development performance evaluations disciplinary actions and day to day Human Resource functions. Responsible for overseeing the development of research contracting and budgeting standards. Directs the negotiation of contracts for clinical trials and determination of internal costs and development of internal budget for negotiations of sponsored and investigator initiated clinical trials in compliance with applicable state and federal laws and regulations especially Medicare and Stark Law. Lead the development and implementation of study builds in the clinical trial management system (CTMS). Additional Duties: Oversee HR functions for the finance team including recruitment hiring performance evaluations disciplinary actions career development and daily operations. Collaborate with leadership to develop and implement strategic plans allocate resources to support growth and foster professional development and shared decision-making among staff. Facilitate transparent communication and collaboration with clinical research programs Clinical Program Services and other key stakeholders regarding operations contracts budgets finance and CTMS. Build and maintain collaborative relationships across departments hospital leadership physician investigators and external research partners. Lead team responsible for internal budget development and negotiations ensuring compliance with FMV Medicare guidelines and state laws. Manage department budgets financial tracking and month-end accounting processes. Direct contract negotiation strategies with clinical trial sponsors. Provide expertise in developing standard clinical trial agreements and collaborate with Legal Affairs to align contracts with site needs. Manage and lead the month end accounting process reviewing for quality assurance and accuracy and addressing areas of concern. Supervise post-award financial management including invoicing revenue accrual vendor payments and financial reporting. Ensure accurate billing coding and compliance with Medicare research funding rules. Lead the development and implementation of CTMS aligning system functionality with clinical protocols contract terms and financial workflows. Balance technology investment with compliance and ROI. Provides resources and experiences to team to interpret clinical trial protocols contracts and budgets into study specific builds as well as allowing for patient management and the AR and AP activities of all clinical trials. Ensure adherence to federal regulations and system policies in clinical trials. Develop and maintain QA processes data controls and compliance standards to protect organizational interests. Knowledgable of Medicare research funding rules and regulations and ensures appropriate billing and coding of patient services to correct research account. Aid in developing standard operating procedures and policies to improve departmental efficiency and performance. Identify and lead quality improvement initiatives. Institutes controls to assure accuracy completeness and confidentiality of research data. Identifies facilitates and coordinates quality improvement opportunities; develops local QA process to address areas of need. Demonstrate deep understanding of the clinical trial lifecycle including feasibility budgeting contract alignment reporting and operational implementation. Advanced understanding and working knowledge of accounting platforms research grant management and clinical trial platforms. Develop and implement strategies to increase revenue and accelerate project timelines ensuring competitiveness and goal achievement. Skills Needed: Computer literate to include advanced level proficiency in Microsoft Office Programs (Word Excel Access and PowerPoint) E-mail and Internet. Thorough knowledge and understanding of HIPPA GCP and ICH regulations clinical trial monitoring and regulatory compliance. Extensive Knowledge of DHHS FDA NCI NIH OHRP and other relevant regulations concerning research and compliance. Knowledgeable of principles of accounting and contract law affecting clinical trials. Ability to successfully budget and negotiate industry contracts for sponsored clinical trials. Highly organized and attentive to details problem solving abilities and ability to work with minimal supervision. Highly motivated and able to take initiative. Ability to prioritize organize plan and implement as well as handle multiple projects/problems simultaneously within a fast paced environment; able to collect and manage large amount of data and maintain databases; communicates progress challenges and results effectively. Knowledge of operations including human resource budget management and work flow planning. Ability to plan chair document and follow-up on administrative and related meetings. Ability to work independently and with minimal supervision. Ability to be flexible multi task and switch priorities as well as work comfortably in a deadline driven environment. Communicates well with physicians patients sponsors and staff on interpersonal and technical levels both verbally and in writing; demonstrates high integrity and maintains confidentiality of all information. Interacts favorably with people by phone and in person and work effectively as part of a team. Demonstrate communication leadership and team building skills; evidence of this should includes dealing well with people effective problem solving appropriately confronting issues motivating others as individuals and as groups planning organizing and directing the activities of others. Excellent written/verbal communication skills to effectively interact with all levels of management departments and users.