Scheduled Hours

40

Position Summary

This position is a member of a multi-disciplinary research team and performs duties associated with the coordination and implementation of multiple phase II/III international trials for the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) conducted in accordance with ICH/GCP and local and regional requirements from protocol concept through clinical study report. This position contributes to the development of trial-related scopes of work, timelines, metrics and deliverables. This position will ensure the completion of study deliverables, milestones and objectives through management of assigned study conduct including oversight of trial CROs and vendors, coordination of internal team and core members and/or external vendors, and providing support to trial teams.

Job Description

Primary Duties & Responsibilities:

• Supports the DIAN-TU Clinical Operations team in the management and operations of clinical trials programs of all operational phases of a study/protocol; Assists with the development, modification, and/or QC of source documents, forms, manuals, workbooks, questionnaires, and the application of research techniques; assists in the development of instructional procedure manuals for study progress, data collection and coding, etc., as needed for data collection, site use, and trial compliance with federal regulations (e.g. ICH/GCP)
• Responsible for the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
• Identify problems and/or inconsistencies and monitor participant and site progress; proactively identify needs, issues, and/or areas of improvement as well as provide input to problem solving
• Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; resolves protocol management issues and recommends corrective action as appropriate.
• Routinely participate in external meetings to ensure timely completion of all protocol requirements (assessments, lab testing, procedures, and treatments) to include routine review of vendor study activities; facilitates communication with vendors to review progress and address issues.
• Performs other duties incidental to the work described above.

Working Conditions:

Job Location/Working Conditions

• Normal office environment
   

Physical Effort

• Typically sitting at a desk or table
   

Equipment

• Office equipment

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications:

The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.

Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience:

Clinical Research (3 Years)

Skills:

Supervision

Driver's License:

A driver's license is not required for this position.

More About This Job

Required Qualifications:

• Basic Life Support certification must be obtained within one month of hire date.
• Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement).

Preferred Qualifications

Education:

Master's degree

Certifications:

No additional certification beyond what is stated in the Required Qualifications section.

Work Experience:

No additional work experience beyond what is stated in the Required Qualifications section.

Skills:

Clinical Research Management, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS)