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Job Title : Project Manager (HS)
Project Manager (HS)
Department :
Medicine Neurological Surgery
- Project Manager to plan, lead and manage implementation and execution of daily activities for multicenter clinical research studies in accordance with approved protocols and guidelines administered by the Department of Neurosurgery under the direction of the Clinical Research Manager;
- assists Clinical Research Manager in daily administrative and research operational activities between the Department of Neurosurgery and national and international partners for joint research projects and grants;
Collaborates with investigators to create, develop and implement new protocols, process and maintain IRB submissions and other regulatory documentation, explores and identifies feasibility of new studies and develops plans to meet protocol requirements.
- participates in development and application of research methodologies, develops communications amongst local coordinating center and subsites, coordinates regulatory compliance, data collection, and assists in development of training and certification materials;
- central meetings preparations; reviews, monitors and authorizes expenditures against research grant; serves as a liaison to subsites, state & federal regulatory agencies, and federal, industry & research sponsors;
- represents and promotes the goals and objectives of the study to various internal and / or external constituencies, as appropriate;
- assists with development, content and oversight of study websites & promotional materials, manages data collection, analysis & reporting;
- oversees and establishes assessment criteria and processes for determination of participant eligibility, recruitment and on-going support for study participants, develops processes & strategies to promote recruitment & retention;
plans, coordinates and assigns daily activities to project staff, monitors and evaluates protocol activity to ensure compliance to all state, federal and sponsor policies, rules and regulations, prepares and participates in study monitoring visits, serves as liaison with IRB, FDA, drug companies and industry sponsors, assists with investigators with preparation of submission of grants to secure continued funding of research projects, collaborates with investigators to write abstracts, manuscripts, articles and research reports for publication in peer-reviewed journals, attends and presents research data at scientific meetings, serves a subject matter leader.
Minimum Education Required
Bachelor’s degree in biological or health sciences, or an equivalent combination of education & 2 years of relevant experience required.
Required Job Qualifications
2-4 years of relevant experience preferred; working knowledge of medical terminology required. Requires successful completion of a background check.
Qualified candidates may be asked to complete a pre-employment physical including a drug screen and background check.
Desired Qualifications and Experience
Master’s degree preferred; considerable experience with planning and administering research projects required, preferably in a health services or clinical research study setting;
proficiency with data abstraction required; clinical research certification from ACRP (Association of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification is strongly desired.
Explore our extensive benefits
Work-life : Flexible and remote work arrangement opportunities where applicable, childcare program, and access to educational, athletic and cultural events.
Retirement : State pension and alternative options with competitive employer contributions, as well as optional supplemental plans.
Health : Medical, dental, vision and prescription coverage, life insurance, flexible spending accounts and wellness programming.
Time off : Paid vacation and sick time, parental and medical leave plus 11 paid holidays. Short and long-term disability options also available.
Financial : Tuition assistance for employees and their dependents, adoption assistance and discounts with preferred vendors and university partners.
Wellness : Lifestyle spending account, employee assistance program, health reimbursement account, and employee wellness program.