Senior Cra Consultant

6 days ago

Remote, Singapore Caritas Clinical Consulting LLC in Singapore Full time

**Compensation**:
$65 - $90 hourly DOE

**Responsibilities**:

- Oncology-experienced Sr. CRA who is based in either Singapore, Taiwan, or South Korea (remote with travel required to clinical research sites)
- Interfaces with the study team to ensure timely initiation and completion of clinical trials
- Responsible for the identification, evaluation, and qualification of investigators and sites
- May prepare and submit essential document packages required for clinical site initiation
- Performs on-site monitoring activities for clinical trials and escalates site issues to Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondence
- Reviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targets
- We have three openings at ~1.0 FTE each
- May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance
- Identify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities
- Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor study database for missing or discrepant data compared to the source record at the clinical site
- Ensure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan)
- Maintain the study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision
- Attend investigators’ meetings, project team meetings, and teleconferences, as needed.
- Understands and applies knowledge regarding local, state, and country regulations (i.e., TGA, etc.) and ICH-GCP
- Maintain training on ICH-GCP, study protocol, and client procedures
- May track regulatory documents may track recruitment, may evaluate study site quality and integrity, and may motivate assigned sites to meet client deadlines
- May create study tools, and study plans, mentor staff, review line listings, and/or conduct staff training/sign-off visits

**Qualifications**:

- 4 years or more as a CRA with site monitoring responsibility **And** 1 year or more in solid-tumor oncology monitoring as a traveling CRA
- Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology
- Must be proficient at tactfully and succinctly managing intra-team communication, as well as interpersonal communication with the site

**About Company**

Our chief concept is in guiding relationships and directing government. We go by "love" in the principle: love your neighbor as yourself, and charity.

Caritas Clinical Consulting was not an act of compulsion, but the care one would have for family.

Bottom line - we created this company to do what we love to do: life-changing medical research, and to dedicate our time, talents, and resources to those who need them.

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