TBI Research Activities Manager

Responsibilities

Leads the execution of analysis plans for primary and secondary study objectives.
Reviews new concepts, protocols and sub-studies and assists in the selection of appropriate study design as well as development of preliminary analysis plans.
Interacts regularly with clinical investigators, clinical site coordinators, regulatory and safety monitoring staff, laboratory personnel, data coordination center personnel, data analysts, biostatisticians, program managers and administrative staff.
Develops, implements and oversees clinical research proposals, specifically the writing of protocols and associated documents (e.g., manuals, consent documents, data collection forms), coordination of the proposal submission and scientific/ethical review processes, management of protocol development activities, oversight and guidance of protocol execution activities at clinical sites and the IDCRP Data Coordination Center, and ensuring project completion and final product development (e.g. presentation and/or publication, recommendations for changes in clinical practice, provision of pivotal data for product licensure, etc.).
Serves as the direct supervisor of clinical research site personnel. May include budgetary responsibility to include plan/forecast and prepare.

Qualifications

• Master's degree required; PhD in brain-health research (e.g., neurology, neuropsychology, neuroscience) with specialized experience in health science or project management (e.g., healthcare management, health science policy) related field is preferred.
• Minimum 4 years of experience working with government agencies and/or contracting required.
• Minimum 6 years clinical research execution, management, coordination, and/or oversight required.
• Prior research experience within the DoD/VA systems of care strongly preferred.

Preferred Experience

• Experience in project management planning and its applicable tools.

Knowledge, Skills And Abilities

• Knowledge and experience regarding the execution of human clinical research trials and federal research administration (e.g., budget management, project/grant management, personnel requirements, regulatory compliance, etc.).
• Ability to use sound judgment in complex problem solving and solution-focused response coordination and execution required.
• Excellent interpersonal and communications skills required.
• Ability to anticipate needs, take initiative and strong attention to details.
• Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
• Experience in the design, conduct and analysis of clinical trials and epidemiologic studies.
• Experience with utilization of electronic medical records preferred; background in microbiology and infectious disease epidemiology preferred.
• Prior supervision and mentorship of study personnel preferred; ability to communicate effectively in written and oral form.
• Ability to effectively communicate research findings in presentations and publications.
• Prior presentation and publication record preferred.
• Excellent verbal, written and interpersonal skills; ability to establish goals and agendas.

Physical Capabilities

• Lifting: Requires lifting materials up to 10 lbs.
• Ability to stand or sit at a computer for prolonged periods

Compensation

The annual salary range for this position is $88,600-$150,800. Actual salary will be determined based on experience, education, etc.

Benefits

HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

Equal Opportunity Employer

Equal Opportunity Employer/Protected Veterans/Individuals With Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)