Research Coordinator-Woodward/Research, (1397)

Schedule: Monday-Friday 0830-1700 with other shifts as needed

Location: Woodward/Research

Salary/Hourly: Hourly

Job Summary

Responsible for managing many aspects of conducting device trials, specimen procurement projects, consenting collections, and testing for research clients both from internal (hospital based, Medical Director- Researchers) and external clients. Serves as central coordinator of study activity at the research site, acting as liaison between the investigator and all internal and external contacts. Responsible for a variety of complex tasks requiring independent judgment regarding the pre-implementation and implementation phases of a study or collection, such as feasibility discussions, contract and budget preparation, study startup activities, subject recruitment and enrollment, maintenance of the study, data management, and study closure. Participate as effective team member in section management relative to communications and operations as appropriate.

Essential Functions

• Review and evaluate protocols and requests with Principal Investigators (PI) and/or research team for feasibility.
• Create budgets for study or project and submit to appropriate process for review and approval.
• Prepare, implement, and assist in the approval of study start-up documents, worksheets, presentations, and activities.
• Serve as a liaison with study Principal Investigators and internal and/or external clients regarding study or project set up, logistics, and progress
• Design data collection forms, such as case report forms (CRF), manifests, or sample accountability logs (SALs) as necessary.
• Handle inquiries regarding the protocol, case report forms and other areas related to the study or project. 7. Conduct subject interviews and obtain Informed Consent.
• Ensure timely and accurate completion and shipping of all study materials.
• Comply with documentation and procedural requirements including (but not limited to): Case report form completion, Enrollment reports, Adverse event and dropout updates, Handling and labeling of samples, and Proper shipment of materials. Address queries in a timely manner. Maintain quality assurance, regulatory documents, recording and reporting study status information to verify that data entered on the CRF is accurate and complete
• Coordinates with all appropriate internal departments regarding research studies or projects including: Information Technology, Accounting, laboratory department supervisors, managers, and technical specialists. 11.Participate in site audits by regulatory agencies when necessary.
• Ensure all study or project supplies are accounted for.
• Archive study documentation and correspondence.

Training

• Establish, maintain, and document appropriate training and competency programs necessary for device trials or procurement projects.
• Schedule logistics meetings with study team to ensure understanding of the study workflow and workload.

Inventory Control

• Provide appropriate inventory control of study investigational use kits/reagents, study supplies, and study gift cards.

Organizational / Employee Development

• Organize daily work to meet the study milestones or deadlines.
• Actively solicit staff input and feedback. Listen with the purpose of understanding employee concerns, questions, ideas and opinions.
• Actively support and implement department procedures, polices and strategies to support the corporate vision, values and strategic plans.
• Assist with marketing of the section(s)’ services through client contact, providing information for marketing brochures, and tours to community groups as appropriate.
• Communicate with department management team and staff to ensure appropriate sharing of information.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Minimum Education

• Associates degree in a relevant field.

Minimum Experience

• One (1) year of relevant work experience in a healthcare or clinical laboratory setting.

Preferences

• Certification as a Research Coordinator.
• Patient or physician interaction experience.
• Clinical research experience.
• Knowledge of Salesforce, Compliance360, and Sunquest computer programs

Immunization Requirements

Prove immunity to Hepatitis B or be immunized or sign a waiver refusing hepatitis immunization. Provide documentation of a PPD test conducted not more than 90 days prior to date of hire or have a PPD test conducted.

General Requirements

• Working knowledge of statistical and variance analysis.
• Skilled in organization and attention to detail.
• Ability to effectively communicate with individuals in varying socio-economic and educational backgrounds.
• Ability to manage multiple projects at one time.
• Ability to meet deadlines and target goals.
• Ability to organize and direct workflow.
• Ability to develop budgets and monitor expenditures.
• Ability to conduct the project in a professional manner while in the presence of subjects, peers, sponsors, monitors or physicians.
• Ability to work both independently and as a team member. Working knowledge of computers, both personal and mainframe, and at least one word processing and spreadsheet program.