Central Services Coordinator JR
1 month ago
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Comply with all company policies, procedures, and conduct.
- Strictly adhere to confidentiality and compliance standards.
- Virtually communicate effectively and courteously with study patients via tele-health platform.
- Demonstrate a caring and pleasant demeanor toward patients and their families.
- Acknowledge study patients' needs and tend to them appropriately.
- Collects patient medical history and conditions.
- Conduct study visits across all sites via tele-health platform.
- Ensure Informed Consents are obtained by on-site staff.
- Participant study visit review and completion.
- Ensure data quality.
- Collect and evaluate medical records for compliance.
- Conduct A/E and SAE assessments.
- Maintain and update regulatory files.
- Verify accuracy of data collected.
- Review study e-source documents to comply with study protocol.
- Manage all required study documentation, training, and timelines on assigned study protocols.
- Participate in CRO/Sponsor/Audit interactions.
- Other tasks and responsibilities as requested to facilitate business needs.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE:
- Some college level courses or related field, preferred.
- 0-2 years experience in healthcare, required.
- 2 years experience working in Clinical Research, required.
- 2 years experience in FDA regulations and GCP.
- Comprehensive knowledge of FDA, GCP and HIPAA as applied to clinical research.
- Knowledge of current studies being conducted.
- Comprehensive knowledge of company's SOPs, policies and Confidentiality agreements.
- Knowledge of safety hazards and procedures that establish a safe work environment.
- Skilled in computer and data collection software
- Excellent customer service skills with internal and external stakeholders.
- A proven ability to multi-task in a rapidly changing environment.
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