Research Project Manager

Job Function Summary:

We are seeking a full-time Research Project Manager to become an integral part of our team. We offer a positive environment with dedicated colleagues in the Department of Neurology at UCSF. In collaboration with the Principal Investigators, the successful candidate will lead the development, conduct, and coordination of all phases of epidemiological studies aimed at identifying risk and protective factors related to and/or the development of treatments for Parkinson's disease.

The Research Project Manager uses skills as a seasoned, experienced research professional with a full understanding of objectives, regulatory rules, clinical research methods and project management best practices. The Research Project Manager is responsible for strategic planning in order to meet project goals, along with ensuring all reporting and study milestones are met including study activation, recruitment targets, development of study materials, management of regulatory materials, and sponsor requirements. This position also requires the candidate to be responsive to sub-investigators and scientific oversight committees.

The Research Project Manager oversees clinical research coordinators and other members of the clinical research team to ensure that staff have uniform training, supervision, and tasks that are appropriate to the job title. The Research Project Manager will also work closely with the data analytics team to interpret and write up results for publication, assist with progress reports; and engage in grant-writing process.

The Research Project Manager serves as a scientific liaison between clinical research coordinators, project managers, statisticians, investigators, and other study personnel in the design and preparation of study-related instruments, materials, operations manuals, and site communications.

The Research Project Manager may assist the Principal Investigator in budgetary and fiscal matters for the department and other duties as assigned.

The ideal candidate has meticulous organizational skills, the ability to work effectively and efficiently in a team, the ability to multitask, and a positive attitude. Impeccable written and verbal communication skills are essential, as is the ability the think independently.

Department Description:

The mission of the Department of Neurology at the University of California, San Francisco (UCSF) includes delivering the most exceptional clinical care to our patients, leading transformative cutting-edge research, and training the leaders of tomorrow in both neurology and neuroscience. Our department's faculty, trainees, and staff work at a University and in a community that values and embraces diversity and strives to make an impact worldwide through our global and public health efforts.

%

of time

Essential Function (Yes/No )

Key Responsibilities

(To be completed by Supervisor)

10

Yes In collaboration with others, organizes, plans, directs and implements the data collection and management in support of clinical research projects.

10

Yes Develops, implements and supervises high quality data collection and documentation including adhering to standards of good clinical practice. Provides supervision and ensures quality of all study procedures. Recommends improvements and training as needed; provides status to study directors and other involved parties.

10

Yes Supervises staff work assignments and schedules to meet clinical research goals and timelines. Meets regularly with assigned staff to set goals and ensure objectives are being met. Directly supervises subordinates' quality and quantity of work to ensure studies meet objectives and are compliant with all regulations. Communicates and collaborates with cross-functional teams.

10

Yes Direct responsibility for delivery of key project/trial goals and objectives, including enrollment targets and outcome event adjudication. Monitors compliance with all policies and processes. Adheres to standards.

10

Yes Serves as the main liaison between clinical trials and program leaders. Proposes solutions to difficulties arising from multidisciplinary research, implements structural changes to maximize time efficiency within the constraints of limited resources.

20

Yes Oversees projects and/or trials from inception through completion, including regulatory approvals, initiation (site visit coordination), protocol implementation, data collection and documentation, data management, writing publications and finalization of sponsor requirements. Prepares and approves final clinical trial documents, including protocol, brochures, training, reports, presentations, safety advisories, and manuals.

5

Yes Interfaces with clinical monitors to review data accuracy, protocol violations and deviations, and regular updates to reporting.

5

Yes Develops and monitors budget processes. Administers fiscal, material and human resources within study budget. Plans and implements resource allocations to individual trials. Suggests ways to be more efficient. If necessary, requests additional resources. Manages revenue collection, invoicing, and reimbursement accounting.

5

Yes Reviews new budget proposals for feasibility with industry sponsors, creates internal budgets for grants, creates invoices, and reconciles budget spending and salary support. Reviews and monitors all research related charges to ensure budgetary compliance.

5

Yes Oversees and analyzes complex databases. Compiles data reports as needed. Provides team, investigators, and clinical fellows with guidance regarding study design and logistics (data collection forms, formatting of data, data management). Assists with publication of abstracts and manuscript. Viewed as an excellent resource for any related questions or concerns about the trial.

5

Yes Recommends salary actions, promotions, and terminations. Conducts necessary personnel actions for assigned staff including disciplinary actions. Recommends changes in staffing and changes to budget to ensure the efficient operation of the function. Participates in recruitment and orientation of new employees.

5

Yes Evaluates assigned staff performance and competency. Defines individual development goals. Mentors professional staff, including employees that are learning a new area of clinical practice. Encourages assigned staff to further their knowledge through clinical education, and certifications.

0

0

0

0

0

100%

Required Qualifications:

• Bachelor's degree in a related area
• Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in a clinical research setting. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical research studies.
• Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical research studies. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
• Broad knowledge of all aspects of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex research design issues.
• Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.
• Demonstrates excellent problem-solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution.
• Strong communicator; includes verbal and written, active listening and critical thinking skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings.
• Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade.
  At least three years of experience in project/program coordination, preferably in a clinical research setting or equivalent
• Self-motivated, positive attitude, strong-attention to detail
  Experience in preparing human subjects protocols, continuing reviews and modifications

Preferred Qualifications:

• Advanced degree in related area
• Familiarity with budgeting
• Working knowledge of neurology, epidemiology, and/or Parkinson's disease
• Clinical Trial Professional certification from a professional society within one year in position.
  
  

Required Qualifications:

• Bachelor's degree in a related area
• Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in a clinical research setting. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical research studies.
• Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical research studies. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
• Broad knowledge of all aspects of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex research design issues.
• Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.
• Demonstrates excellent problem-solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution.
• Strong communicator; includes verbal and written, active listening and critical thinking skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings.
• Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade.
  At least three years of experience in project/program coordination, preferably in a clinical research setting or equivalent
• Self-motivated, positive attitude, strong-attention to detail
  Experience in preparing human subjects protocols, continuing reviews and modifications

Preferred Qualifications:

• Advanced degree in related area
• Familiarity with budgeting
• Working knowledge of neurology, epidemiology, and/or Parkinson's disease
• Clinical Trial Professional certification from a professional society within one year in position.