What are the responsibilities and job description for the Clinical Data Coordinator position at Comrise?
Position: Clinical Data Coordinator
Location Address: Nashville, TN 37203 - Hybrid
Shift(s) required: M-F 8-430 CST
Duration: 6 Months Contract.
Summary of Key Responsibilities:
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.
Duties include but are not limited to:
- 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 company SOPs, Good Clinical Practice (GCP), and FDA regulations.
- All other duties as assigned
Mandatory:
- Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement”
- During your employment with company you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
Competencies:
- FDA Code of Federal Regulations and GCP, Medical and research terminology
- Company organizational policies, standard operating procedures and systems
Minimum Qualifications
Education:
Minimum Required:
- High School Diploma (GED)
Preferred:
- Bachelor’s Degree (4 yr program)
Experience:
Type of Experience-
- Work experience in healthcare
Time - Given the type of experience stated above:
- 1 year but less than 3 years
Salary : $20 - $22
