Job ID #: 14240 City, State: Albuquerque
Functional Area: Research Department Name: TRI Research Support
Position Type: Regular - Full Time Education Required: See Minimum Qualifications
Experience Required: See Minimum Qualifications Relocation Provided: No
Job Summary
Responsible for managing many aspects of conducting clinical trials, 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, 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.
Research:
1.
Review and evaluate protocols with Principal Investigators (PI) and/or research team for feasibility.
2.
Create budgets for study or project and submit to appropriate process for review and approval.
3.
Prepare, implement, and assist in the approval of study start-up documents, worksheets, presentations, and activities.
4.
Serve as a liaison with study Principal Investigators and internal and/or external clients regarding study set up and logistics.
5.
Design data collection forms, known as case report forms (CRF) as necessary.
6.
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.
8.
Ensure timely and accurate completion and shipping of all study materials.
9.
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.
10.
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.
12.
Ensure all trial supplies are accounted for.
13.
Archive study documentation and correspondence.
Training
1.
Establish, maintain, and document appropriate training and competency programs necessary for clinical trials.
2.
Schedule logistics meetings with study team to ensure understanding of the study workflow and workload.
Inventory Control
1.
Provide appropriate inventory control of study investigational use kits/reagents, study supplies, and study gift cards.
Organizational / Employee Development
1.
Organize daily work to meet the study milestones or deadlines.
2.
Actively solicit staff input and feedback.
Listen with the purpose of understanding employee concerns, questions, ideas and opinions.
3.
Actively support and implement department procedures, polices and strategies to support the corporate vision, values and strategic plans.
4.
Assist with marketing of the section(s)’ services through client contact, providing information for marketing brochures, and tours to community groups as appropriate.
5.
Communicate with department management team and staff to ensure appropriate sharing of information.
Minimum Qualifications
MINIMUM EDUCATION:
• Bachelor’s degree in a relevant field.
MINIMUM EXPERIENCE:
• One (1) year of relevant work experience in a healthcare or clinical laboratory setting.
OTHER REQUIREMENTS:
• Thorough knowledge and experience of the research process; including knowledge of Clinical Practice/ICH Guidelines, laboratory practice standards and associated federal requirements and regulations.
PREFERRED:
• Advanced degree in a health-related field.
• Certification as a Research Coordinator.
• Patient or physician interaction experience.
• Clinical research experience.
• Knowledge of Salesforce, Compliance360, and Sunquest computer programs.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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