GENERAL SUMMARY OF DUTIES - Provides support to clinical trial specialist (CTS) on a daily basis, ensures all activities are conducted according to company SOPs, and all applicable GCP and ICH regulations and guidelines.
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
- Supports CTS to meet industry trial data deadlines
- Obtain source documentation for patients enrolled into clinical trial
- Assist CTS with case report form completion
- Assist CTS with query resolution
- Assist in SAE reporting and tracking
- Create and maintain patient visit tracking spreadsheets for CTS
- Maintains and archives study administrative file
- Attends meetings as assigned and reports on actions.
- Participates in educational activities and programs.
- Maintains strictest confidentiality.
- Works closely and effectively with all other department personnel.
- Assists other staff as requested and performs other related work as needed.
- Assigned special procedural projects to enhance the functioning of Drug Development Data Operations
- Throughout the conduct of the conduct of the clinical trial assesses adherence to SCRI SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines.
KNOWLEDGE, SKILLS & ABILITIES - This position requires the following minimal requirements:
- Proficient in Microsoft Office software, including Word, Excel, and Access; high computer literacy and ability to learn new software if required
- Detail-oriented with knowledge of scientific, medical, and regulatory terms. Excellent English written and oral skills.
- Knowledge of GCP and GMP
- Proven ability to multi-task in fast paced environment is essential.
- Strong interpersonal, communication, and organizational skills.
- Ability to manage, organize, and make decisions.
- Minimum of Bachelor's Degree or Associates Degree with data entry experience
- 1 year experience working in health care organization
- Clinical trials support or pharmaceutical industry experience preferred
- Or equivalent experience