Job Summary

Coordinate all study related department activities to ensure compliance with the protocol, applicable study documentation, and applicable SOPs. Provide guidance to technical staff on assigned study projects.
  
ESSENTIAL DUTIES AND RESPONSIBILITIES:  
•    Proficient in preclinical or clinical study set up in LIMS system. Ability to cross train between the two disciplines.
•    Read study protocols or Sponsor guidance documents and extract pertinent information related to required action items and provide recommendations to study director/supervisor on technical and logistical aspects of protocol design.
•    Perform tasks related to preparation and documentation of materials in support of sample management. Includes entry of relevant information into LIMS systems or current database and assisting with outgoing shipments. 
•    Assist other sample management staff and study directors with sample discrepancy resolution as needed.
•    May work in conjunction with other departments to coordinate assignments to facilitate scheduling of study-related processes on assigned studies to ensure protocol or study requirements are met.
•    Assist in the preparation and review of department calendars using protocols and other study documents to ensure all activities are appropriately scheduled.
•    Act as liaison between department staff, other departments, and sponsors on assigned studies.
•    May communicate with Sponsor representatives (e.g., the Sponsor, or third-party laboratories) on protocol-driven, study related activities.
•    Assist sample management staff with study related activities.
•    Review and file study data generated/collected by the technical staff.
•    Serve as a model as it relates to effective time management, communication and utilization of resources, and safety in the laboratory. Perform a wide variety of laboratory tasks independently.
•    Maintain and perform record keeping.
•    Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs), Good Clinical Practice Regulations (GCP), and Standard Operating Procedures (SOPs).
•    Perform all other related duties as assigned.

The pay range for this position is between $30.00 and $36.00 an hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

QUALIFICATIONS:
•    Education: High school diploma or General Education Degree (G.E.D.) required. Associate’s (A.A/AS.) degree in a life sciences field preferred.
•    Experience: Minimum of 3-5 years related experience, including GLP and/or GCP experience required, or must have demonstrated full knowledge of competencies and positive performance at the previous level.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Certification/Licensure: None.
•    Other: Good keyboarding skills, proficient in utilizing personal computer, e-mail and standard office software packages (word processing, spreadsheet, presentation, database). Ability to work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Acts independently to determine processes and procedures on new assignments and may provide guidance and oversee the activities of other support personnel.

PHYSICAL DEMANDS:
•    Must be able to perform procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
•    Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.
•    Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT:
•    General office working conditions, the noise level in the work environment is low.