Research Program Coordinator II - Data Operations Studies

Summary

Under the supervision of the Studies Manager and Lead, ensures high quality clinical data are available for regulatory submissions, safety monitoring, contracted deliverables, and publications. Serves as a liaison to respond to and engage network centers in accurate and timely data submission to Center for Blood & Marrow Transplant Research (CIBMTR).

Primary Responsibilities

Protocol and Site Management

• Maintains Data Operations educational guides/manuals, reports, and files for assigned studies.

• Assists training study centers.

• Maintain Data Operations assigned study timelines.

• Maintain and monitor assigned study accruals to ensure enrollment goals are met.

• Assists with study related problem-solving activities at enrolled centers.

Data Management

• Assists on the development and collection of study data through comprehensive databases and forms.

• Assist the Research Program Coordinator III and Studies Manager in performing high-quality validation of new datasets.

• With oversight, perform high-quality analysis of study data.

• Generates queries to member centers, resolve data issues, and ensure data quality checks are accurate to established business and clinical requirements.

• Prepare analyzed data in a suitable format for Data Operation deliverables.

• Report study data and progress to Data Operations Studies Manager, program stakeholders, PI’s and CIBMTR scientific directors.

Other Duties

• Communicate with peers, study teams, and management as appropriate to support studies and goals.

• Participate in appropriate committees relevant to the advancement of the corporate program and the profession.

• Assist in training of Data Operations study staff.

• Other duties as assigned.

Knowledge – Skills – Abilities

• Knowledge of quality assurance, technical, business, consultation, project management, and cultural awareness.

  Customer focus, building trust, communication, critical thinking, and influencing skills. Organization, time management, interpersonal, communication, and problem-solving skills. Strong computer skills. Highly skilled with MS Office, especially Excel. Understands databases; good technical skills in querying and analyzing data. Manage multiple deadlines and priorities while ensuring quality and timeliness.

Qualifications

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required Education:Bachelor’s degree

Minimum Required Experience:3 years

Preferred Education: Bachelor’s degree, preferred in a healthcare or science related field.

Preferred Experience: relevant experience in data analysis, data management, project management in a clinical research environment

Required Certification/Licensure(s): CITI training required within 90 days of hire.

Field:Oncology, Bone Marrow Transplant, or Cellular Therapy

Physical Requirements

Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Work Environment

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Sensory Acuity

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.