Employment Opportunities:

CLINICAL TRIAL ASSOCIATE (Bannockburn location)

Job Purpose:

• The Clinical Trial Associate (CTA) is responsible for logistical and tactical activities related to study management in partnership with Program Managers, clinical trial managers and lead clinical research associates. This position offers a career pathway to a join a growing Clinical Affairs/Clinical R&D Department and contributing substantially to Cytochroma’s drug development programs. There is an opportunity for growing responsibility and activities commensurate with the individual’s capabilities and eagerness to learn. This role will report to a Program Manager for purposes of training, mentoring and direct management of responsibilities.

  As a key member of the study teams, the CTA will participate in the day-to-day activities involved in the management of clinical trials. These activities include:

  1. Collecting, reviewing, processing and ensuring completeness of documents required in clinical trials;
  2. Developing and maintaining clinical spreadsheets/databases/trackers and/or tools;
  3. Writing of clinical trial related documents as assigned (i.e. ICFs, protocols, CRFs, RFPs etc.);
  4. Managing the distribution of clinical trial supplies and the storage of clinical trial samples;
  5. Assisting with monitoring visits at clinical sites and assessment of other clinical vendors (i.e. central laboratories); and
  6. Establishing and maintaining study files (i.e. TMF, budget files).

Duties and Responsibilities:

Performed job duties supporting Clinical Development Teams with minimal guidance:

• Set-up, maintain, oversee and reconciles trial master files;
• On an as-needed basis, participate in monitoring visits of clinical sites and laboratory centers to review protocol adherence, data reporting accuracy, adequacy of study records, and accountability/tracking of clinical trial materials such as investigational drug and biological specimens;
• Communicates with sites regarding trial start-up, conduct, and close-out activities;
• Coordinates communication of tracking information between Clinical Affairs Program manager, trial manager, Sr CRA and vendors;
• Maintain and coordinate generation of clinical trial status reports and tracking spreadsheets, databases and/or tools to support the conduct of a clinical study from start-up to close-out;
• Manages and tracks study specific payments;
• Generates and reviews management reports from internal tracking systems at requested intervals;
• Prepare clinical study synopses/protocols, amendments, model informed consent forms, Investigator meeting presentation materials, RFPs and other clinical trial related documents as assigned;
• Review and revise laboratory manuals, TLFs, CRFs and other clinical trial related documents as assigned;
• Oversee management of clinical trial supplies and samples including investigational product ;
• Collaborates with Program Managers, Clinical Trial Managers and Sr CRA on the development of certain study specific plans and/or processes (i.e. external training schedules, investigator meeting, monitoring plans, central laboratory transition activities including vendor selection etc.);
• Develop, collect, review and process clinical trial related documents (i.e. informed consent forms, FDA form 1572s, curriculum vitae, financial disclosure forms, IRB/EC approvals and correspondences, etc.)*
• Ensuring that essential documents are in compliance with requirements set forth by regulatory agencies (e.g., FDA, TPD, EMEA, ICH-GCP, SOPs and working practice guidelines, etc.)*
  * Currently a core function of the Department of Regulatory Affairs & QA

Qualifications:

• MUST have BS/BA degree.
• Minimum 1 year of previous clinical research experience (Biotech or pharmaceutical industry experience ideal; but will also consider a combination of biotech or pharmaceutical industry experience and Clinical Research Center/Research Institutes experience (or) Clinical Research Center/Research Institutes experience).
• Demonstrated experience with clinical trial documents/essential documents
• Knowledge of ICH/GCP and Regulatory Compliance
• Proficient computer skills across multiple applications
• Travel Amount: Approximately 30%

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in the subject line of your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.