Project Manager

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 Psychiatry and Behavioral Health in daily administrative and research operational activities between the Department of Psychiatry and Behavioral Health 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 amp; federal regulatory agencies, and federal, industry amp; 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 amp; promotional materials, manages data collection, analysis amp; reporting; oversees and establishes assessment criteria and processes for determination of participant eligibility, recruitment and on-going support for study participants, develops processes amp; strategies to promote recruitment amp; 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.

Duties Description:

40% Oversees, manages and coordinates implementation and execution of clinical research activities within the Department of Psychiatry amp; Behavioral Health program; ensures compliance with all local, state and national regulations; serves as primary resource for multi-site collaborative projects

30% Coordinates and prepares protocol applications, human subject and regulatory documents for IRB review; serves as a liaison with PI (s), IRB, other officials and sponsors as needed

25% Oversees and prepares for external quality assurance and control reviews; actively participates in site visits and audits; assists with study set up preparation including systems for data capture, quality assurance and data extraction; assists with training new staff members working on assigned studies

5% Provides support related to financial management of assigned projects.

Experience:
Bachelors degree in biological or health sciences, or an equivalent combination of education amp; experience required; Masters 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; 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.