OVERVIEW

Perform a variety of research, data base and clerical duties of a complex and technical nature in support of clinical trials to ensure adherence to protocols and quality of information received.

MAJOR DUTIES AND RESPONSIBILITIES

• Participate in ongoing clinical and study specific training

• Participates in visits conducted by monitors and SIV as needed.
• Responsible for compiling source documents for active studies and ensuring source binders contain the appropriate documentation to screen upcoming patients.
• Responsible for assisting in EDC completion

• Takes part in site and/or company team meetings as needed
• Perform all activities in compliance with Quality standards (SOP’s, training, etc.) at the site level
• Assist in ensuring all project timelines and deliverables are met as scheduled
• Responsible for processing and shipping labs- IATA certified.  This can include pick up/drop off of certain items near site location.

• Inputting invoices into CC, responsibility could vary by site location.

• Protects confidentiality of any and all sensitive information related to HIPPA and sponsor guidelines
• Assist in ensuring that study materials and lab kits are shipped and resupplied as requested
• Conducts all work in accordance with Good Clinical Practices (GCPs), CRS Standard Operating Procedures (SOPs), and principles set forth in the CFR and ICH guidelines
• Participates in audits (internal or external) at assigned site, as needed
• Communicates, as necessary, with the vendors and supporting functions at the site level
• Maintaining working knowledge of Clinical Conductor
• Responsible for on-call rotation (personally being on-call for assigned rotation time frame)
• Any other task assigned by direct supervisor and assist the site team

SUPERVISORY RESPONSIBILITY:

This position has no supervisory responsibilities.

WORK ENVIRONMENT:

Mixture of Clinical and Office environment where you would be sitting at a desk working/typing on a computer approximately 50% of the time and with patients and in the lab on your feet 50% of the time.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  While performing the duties of this job, the employee is regularly required to communicate, converse with, and exchange information. The employee is frequently required to be in stationary position at least 50% of the time; use hands and fingers to grab; and reach with hands and arms.

The Employee is occasionally required to run; traverse; and stoop, kneel, crouch or crawl. The employee may occasionally lift or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

This position requires some limited travel around surrounding areas of assigned site.

COMPETENCIES

• Strong communication and organizational skills
• Proven time management and motivation skills
• Flexible and ability to work with multiple deadlines and priorities
• Team player who can also effectively work independently
• Take initiative by anticipating and eliminating potential barriers
• Solution-oriented and problem-solving attitude.  Focused on improving current processes for better efficiency and faster turn-around
• Ability to communicate and work with people at multiple levels (site, clinic, management, sponsor, CRO, etc.).  Must for able and willing to take direction from others.

EDUCATION AND KNOWLEDGE REQUIREMENTS

• High School diploma or equivalent required
• Previous medical assistant training and/or work experience is strongly preferred
• Possess computer skills, intermediate experience with MS Office