Career Center

Position Purpose

Under the supervision of the Principal Investigator(s) (PI), the Project Director is responsible for the implementation of and ongoing management of several addiction research projects.  In this role, the project director oversees all protocol activations, acts as lead liaison with the PI(s) and study sponsors, supervises study staff members, and ensures that all study and research objectives are met.

Major Responsibilities

Site Preparedness and Protocol Activation          20 %

Supporting Actions:

• Serves as primary contact for PIs and sponsor(s).

• Independently establishes work plan, timeline, and staffing for each phase of project, and arranges assignment of projected personnel (including but not limited to the hiring and management of staff).

• Reviews preliminary protocol, associated documents and communicates to study teams.

• Assesses protocol requirements and prepares site for study procedures.

• Provides Brown Research Administration or sponsor with requested pre-study documentation.

• Collaborates with grant manager(s), PIs, and partners to create a reasonable and accurate budget for study implementation and ongoing activities.

• Communicates progress with Center Manager, Center Director, and PIs.

• Develops protocol documents: Informed Consent Forms, Source Documents, and other protocol specific documents. 

• Prepares and submits protocol documents for IRB review. 

• Manages study specific regulatory documents according to guidelines of study sponsor.

• Collaborates with the Center Manager to create relevant SOPs to support the logistics of all new and ongoing study protocols. 

• Oversees and coordinates protocol training for site staff.

• Ensures site and staff preparedness for site activation.

Oversees the Coordination of Research Studies         30 %

Supporting Actions:

• Plans, directs, coordinates, and leads activities of several addiction-related research projects to ensure that goals, objectives, and all elements are accomplished.

• Oversees the daily protocol and study operations to ensure compliance with protocol and quality.

• Supports study team to ensure that study and protocol procedures are followed and managed according to sponsor and organizational SOPs. 

• Works with study teams to track accrual and retention goals; troubleshoots and problem-solves to ensure these goals are met. 

• Identifies and evaluates areas for improvement and implements changes in a timely manner to ensure ongoing quality and success.

• Continually assesses staff capacity, quality of work, and work load and works with team members to ensure team capacity.

• Monitor protocol operations to ensure compliance with local and federal regulations.

• Troubleshoots research issues and problems raised by sponsors, funders, collaborators, and staff.

• Responsible for regular operation meetings with study staff to ensure protocol objectives are met and to ensure that ongoing communication is efficient and effective. 

• Promotes open communication and discussion among staff regarding changes in protocols, procedures, logistics and other pertinent information.

• Ensures staff members receive ongoing training as needed and/or requested.             

Quality and Data Management         20 %

Supporting Actions:

• Responsible for updating and operationalizing the Quality Management (QM) plans of each protocol, including management of the daily Quality Control (QC) procedures and Quality Assurance (QA) review.

• In collaboration with the PIs and the Center Manager, responds to QM findings and implement corrective action.

• Provides or coordinates trainings for staff on QM procedures.

• Reviews and responds to data error reports and findings from audits to ensure full compliance with protocol, network standards, and regulations

• Identifies areas of needed improvement and implements plan in coordination with PIs and Center Manager.

• Directs staff to perform quality control on data collection systems to assure and maintain the quality of all written and computerized data.

• Completes relevant writing tasks (i.e., papers, posters, abstracts, data reports, presentations, grants) as needed and as available.

• Directs and develops public outreach, press releases, public presentations, community advisory board presentations, and web site development and content.

• Presents data/study information at local, national, or international meetings and conference calls.

Budget and Financial Management         15 %

Supporting Actions:

• Drafts all protocol budgets.

• Reviews all contracts and budgets.

• Manages ongoing study funding and budgets to determine time frame, funding limitations, procedures for accomplishing project goals, staffing requirements, and allotment of available resources to various phases of project.

• Reviews and tracks monthly project financial reports.

Manage communication with investigators, sponsors, & other administrators        15 %

Supporting Actions:

• Actively participates on all study-related conference calls and attends study specific operations meetings and trainings locally and nationally.

• Maintains regular communication with project PIs, co-investigators, and other study staff as needed at all sites.

• Schedules and runs as-needed conference calls with investigators and study staff and is in regular communication with study investigators, study staff, and regulatory bodies as needed.

• Independently generates and disseminates as needed descriptive statistics, future projections regarding recruitment, follow-up, retention and compliance, and other data analysis for the sponsor and PIs.

• Assists with logistics of full study team meetings and conference calls.

• Sits on protocol teams and committees and requested.

Decisions Position is Free to Make

• Independently establishes work plan, timeline, and staffing for each phase of project, and arranges assignment of projected personnel (including but not limited to the hiring and management of staff).

• Directs and develops public outreach, press releases, public presentations, community advisory board presentations, and web site development and content.

Dimensions

This person will direct between multiple (currently 3 ⓠ4) grant-funded research projects with budgets totaling over $1 million throughout the course of the grants.  They will supervise a minimum of 3 research staff as well as coordinator research-related activities of multiple post-docs and doctoral students.

Job Qualifications and Competencies

Education

• Required:  MBA or MPH in health care management or Masterâ™s in a related field required

• Preferred:  PhD or doctoral-level degree

Experience: 3-5 years project management and 2-3 years research experience preferred.

Job Competencies

• Supervisory experience required.

• Addiction-related experience preferred.

• Grant and report writing experience desirable.

• Demonstrated ability to understand and explain protocols (inclusion/exclusion criteria, demographics, disease prevalence).

• Excellent communication and writing skills.

• Enthusiastic and professional attitude.

• Proficiency with MS Office and the Web, experience with design applications helpful.

• Data management experience desirable (Lime Survey, Redcap, ACCESS, Qualtrix, etc).

• Knowledge of and sensitivity to diverse communities, particularly communities of color and gay/lesbian/ bisexual/transgender communities.

• Willingness to travel locally, domestically, and internationally as needed

• Candidates must possess a willingness and ability to support a diverse and inclusive campus community.

Physical Demands and Working Conditions

General Physical Demands

☒ Requires ability to read

☒ Must remain in stationary position for long periods of time at desk or computer

☒ Requires moving around campus

☒ Requires occasionally standing, sitting, walking; using hands to finger, handle, or feel objects, tools or controls;  reaching with hands and arms; climbing stairs; hearing; talking

☒ Requires frequently moving about inside the office to access printer, files, and other materials/equipment

☒ Operates a computer and other office equipment

☒ Some travel may be required

Lift/Carry/Push/Pull

☒ Typically 10 to 20 pounds

Use of Chemicals

☒ Limited exposure to chemicals

All offers of employment are contingent upon a criminal background check and education verification that are satisfactory to Brown University.