Clinical Trial Assistant

This is a contract job opportunity. potential for perm.

Position: Clinical Trial Assistant 8924

Location: Madison WI

Schedule: M-F 8 am - 5 pm

Projected duration: 6 months + potential for perm

Benefits are available

pay rate - $21 to $23 per hour depending on experience

Essential job duties:

¨ (20%) Data Planning – responsible for all data aspects of studies including review of draft protocols, attending Clinic Start Up Meetings, supporting the workbook (CRF) design process, training plans for non-standard study data capture and attend Biometrics start up meetings as required.

¨ (20%) Ensure that the data entry and QC of dose escalation data is completed within the required timelines.

¨ (15%) Complete daily ongoing QC of all study data across Clinical Operations including daily shop floor QC.

¨ (15%) Act as principle host for sponsor CRF monitoring visits. Promoting a professional image of Leeds CRU and building strong collaborative working relationships with CRA’s.

¨ (10%) Query Resolution – ensure all database queries; sponsors written data queries, CRA monitoring queries and internal QA audit findings are resolved within the agreed timelines.

¨ (10%) Responsible for ensuring the weekly Data Entry Schedule is updated and accurately reflects study workload.

¨ (5%) Study Close Down - Ensure completed CRF’s are signed by the Principal or Associate Investigator and that all CRF’s and source data is archived on completion of the study.

¨ (5%) Perform other job related duties as assigned.

Minimum requirements

Typically looking for 1-2 years of data handling experience. Experience can be from a clinical or non-clinical background. For example financial data handling background.

¨ Excellent written and oral communication skills

¨ Ability to prioritize workloads

¨ Good organizational skills

¨ Previous customer service experience desirable

Summary:

The main function of a clinical trials assistant is to assist the clinical research teams in ensuring the most effective and efficient conduct by providing administration and project tracking support.

Job Responsibilities:

To provide general administrative support to the Clinical Operations Department and assistance.

To support the Clinical Operations teams with ongoing conduct of studies.

To assist project teams with study specific documentation and guidelines as appropriate. Set up, organize and maintain clinical study documentation.

Process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.

Assist in quality control audits of clinical study documentation.

To assist in co-ordination of Investigator payments, if applicable.

To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.

To assist with the coordination of team member tracking.

Skills:

Verbal and written communication skills, attention to detail, and problem solving skills. Basic ability to work independently and manage ones time. Basic knowledge of the information and techniques needed to diagnose and treat human injuries and diseases. Basic ability to analyze data and accurately document and record results. Education/Experience: High school diploma or GED required. Associate's degree in medical technology or vocational training preferred. 0-2 years experience required