Department: Medical Research
Job Title: Clinical Trial Associate - Oncology
Description:
The Clinical Trial Associate is responsible for providing assistance to the Clinical Trial Manager(s) and department-wide support, including:
- Collect, review and process regulatory documents such as informed consent forms, FDA form 1572s, curriculum vitae, financial disclosure forms, IRB/EC approvals and correspondences, etc., and ensuring that said documents meet requirements set forth in all applicable regulatory guidelines (e.g., FDA and EU Clinical Trial Directive regulations, ICH-GCP, ARIAD SOPs and working practice guidelines, etc.)
- Initiate and manage shipments of investigational drug and other clinical trial related supplies
- Maintain tracking tools and spreadsheets of required investigative site regulatory documents and contact information
- Set-up and maintain investigative site files
- On an as-needed basis, participate in routine monitoring visits of clinical 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
- Assist with the preparation of study amendments, model informed consent forms, laboratory manuals, and other clinical trial related documents as assigned
- Maintain and coordinate generation of clinical trial status reports and tracking spreadsheets and/or databases
Technical Skills
Strong organizational, analytical and communication skills are required. Proficiency with computer software such as Word, Powerpoint, Excel, and Microsoft Project are desired, however appropriate training will be provided where needed. Knowledge and understanding of the clinical trial process and GCP/ICH guidelines are a plus.
Job Description
As a key member of the medical research team, you will participate in the gamut of activities involved in the daily management of clinical trials. These activities include: (1) collecting, reviewing, and processing documents required by regulatory guidances, (2) preparing and maintaining spreadsheets/databases, (3) assisting with the writing of clinical trial related documents, such as model informed consent forms and protocol amendments, (4) managing the distribution of investigational drug and other clinical trial supplies, (5) preparing clinical trial status reports (6) assisting with routine monitoring visits at clinical sites and central laboratories, and (7) establishing and maintaining study files.
This position provides an entry-level opportunity to join a growing Clinical Operations/Medical Research Department, and contribute substantially to the successful implementation of Oncology trials with the lead product candidates at ARIAD. In addition, there is an opportunity to build skills in the science of clinical research as well as oncology through day-to-day activities and close interactions with the medical research group, and formal training and participation in oncology meetings where clinical trial data are presented. There is an opportunity for growing responsibility and activities commensurate with the individual’s capabilities and eagerness to learn.
Job Requirements:
This position requires at least a BS degree. Prior pharmaceutical, clinical or academic research experience is preferred. The qualified candidate will possess proficient oral and written communication skills, and be detail-oriented with strong organizational abilities. Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment. Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required. Must be able to travel (mostly domestic, 10- 20%). This travel includes site visits as well as participation in major Oncology meetings where clinical data are presented.
