Clinical Trial Assistant Jobs

As a Clinical Trial Assistant (CTA) you will assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.Provide support to Regulatory and CRO, to ensure a complete and accurate Trial Master File documentation.

Essential Job Functions/Responsibilities:

Responsible for all activities related to implementation of clinical studies including. • To provide general administrative and regulatory support to the Clinical Operations Team Including:

•To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s)

•To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.

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

•To be familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.

•To be familiar with the roles of the Clinical Research Associates (CRA) i

•To assist project teams with study specific documentation and guidelines as appropriate.

•To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.

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

•To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).

•Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.

•Conduct data review of data entered into EDC system and review queries initiated by CRO

•To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.

•To assist project teams with trial progress tracking by reviewing the study data base

•To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.

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

•To contact or assist CRO in with contacting clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).

•To assist in the tracking and distribution of safety reports

•To attend project team meetings and generate meeting minutes.

•Other duties as assigned

Knowledge, Skills and Abilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:

•Research or health care related academic or work experience preferable. A Nursing or University degree (US Bachelor Level or equivalent) in a health-related field; or at least five (5) years direct clinical trial experience in a research-related organization

•Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.

•Good written and verbal communication skills.

•Good written and spoken English.

•Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.

Compensation $25 - $35 per hour