Project Specialist I

BASIC PURPOSE: The Project Specialist, coordinates site and operational activities, from study start to study close, to ensure the timely delivery of high-quality service deliverables for assigned studies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Assist in preparation and reproduction of study materials during study start-up phase of clinical trials
• Follow up with outstanding documentations from clinical sites to complete site qualification
• Schedule logistical and technical trainings with site personnel
• Create test run requests for sites submitting digital data
• Review, process, track and monitor all study related data received from sites
• Assist in the monitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management
• Manage site communications, generate site and patient reports and queries, and verify reports prior to distribution to clinical sites and sponsors
• Investigate and complete logistical edit checks
• Report issues found with study systems (i.e. study database, reading analysis system)
• Perform day to day data processing activities
• Ensure data is collected and maintained according to applicable SOPs and/or study protocol requirements
• Communicate with clinical study team and/or sponsor regarding deliverables
• Understand functions of software used to produce and collect data
• Study database maintenance (e.g., change of contact information)

Assist Project Managers with project administration by

• Planning and coordinating the site start-up activities
• Reading and understanding project protocol documents
• Entering, maintaining, and tracking of data in internal software
• Participating in project meetings, conference calls, and training calls

Assist Project Managers in maintaining, reviewing and communicating project progress by

• Reviewing and analyzing project tracking weekly
• Generate, track and resolve data queries
• Identifying site and data trends, and recommending actions to Project Manager
• Communicating and following up on project tracking discrepancies
• Assisting in monitoring data flow
• Generating, reviewing and distributing weekly/monthly project tracking reports
• Ensures the development and adherence to project timelines as they relate to therapeutic   processes by following up on outstanding items including missing data, incomplete paperwork, etc.
• Managing site communication, including distribution of subject data reports
• Assisting in tracking and resolving of client issues
• Scheduling and tracking completion of site training
• Serving as additional point of contact to client, sites, sponsors, etc.
• Keeping supervisor advised of current issues

Maintain client (internal and external) satisfaction by

• Responding to inquiries in a professional, courteous and timely manner

Maintain Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)
• Assisting in establishing and enforcing departmental standards
• Participating in the modification of company SOPs related to the therapeutic team

Maintain Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training

QUALIFICATIONS AND SKILLS NEEDED:

Education: High School Graduate or Associate/bachelor’s degree in bioscience, computer science, information technology or related field preferred

Experience:

• Familiarity with PC-based computers and standard software packages including e-mail, word processors, Excel spreadsheets and databases.
• Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a
• pharmaceutical environment preferred
• Knowledge of “good clinical practices” preferred
• Familiarity with network navigation and file saving conventions, including moving/copying files and folders

Additional skill set:

• Ability to work in group setting and independently; ability to adjust to changing priorities
• Excellent attention to detail and orientation toward meticulous work
• Strong interpersonal and communication skills, both verbal and written
• Ability to provide and maintain a professional and positive attitude
• Leadership skills. Self-motivated with ability to work in teams with minimal supervision, with aggressive deadlines
• Strong documentation and organizational skills
• Goal oriented

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  CLARIO reserves the right to amend or change this job description to meet the needs of CLARIO.  This job description and any attachments do not constitute or represent a contract.

The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.

EEO Statement
Clario is an equal opportunity employer.  Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.