What are the responsibilities and job description for the Data Coordinator position at CereCore?
Classification: Contract
Contract Length: 6 months
Summary
Provides support to the Clinical Research Coordinator and Research Nurse on a daily basis, while ensuring all activities are conducted according to company SOPs and all applicable FDA regulations and ICH-GCP guidelines.
Responsibilities
Contract Length: 6 months
Summary
Provides support to the Clinical Research Coordinator and Research Nurse on a daily basis, while ensuring all activities are conducted according to company SOPs and all applicable FDA regulations and ICH-GCP guidelines.
Responsibilities
- Support CRC to meet industry trial data deadlines
- Obtain source documentation for patients enrolled onto clinical trials
- Assist CRC with case report form completion
- Assist CRC with query resolution
- Assist in SAE reporting and tracking
- Create and maintain patient visit tracking spreadsheets for CRC
- Maintain and archive study administrative file
- Maintain and archive regulatory files
- Assist in ensuring source document templates are accurate
- 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 colleagues
- Assists other staff as requested and performs other related work as needed.
- Assigned special procedural projects to enhance the functioning of the research program
- Throughout the conduct of the trial, assesses adherence to Sarah Cannon SOPs, Good Clinical
- Practice (GCP), and FDA regulations.
- All other duties as assigned
- Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement”
- During your employment with Sarah Cannon you will be routinely assigned training requirements.
- Expected to complete any training assignments by the due date.
- 1-3 years of work experience, preferred in healthcare
- Work independently and multi-task in a fast-paced environment
- Interpersonal, communication, and organizational skills.
- Ability to manage, organize, prioritize, and make decisions FDA Code of Federal Regulations and GCP, Medical and research terminology
- Sarah Cannon organizational policies, standard operating procedures and systems
- Computer skills, including use of Excel and PowerPoint