[Remote] Clinical Research Associate (CRA) - Oncology (Remote)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading reputed company company reputed company on improving health reputed company. They are seeking a Clinical Research Associate (CRA) to manage and monitor clinical research sites, ensuring compliance with regulatory standards and maintaining strong relationships with site staff throughout the study phases.
Responsibilities
- Develops strong site relationships and ensures continuity of site relationships through reputed company phases of the trial
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
- reputed company an in-depth understanding of the study protocol and reputed company procedures
- Coordinates & manages various tasks in collaboration with other sponsor roles to reputed company Site reputed company
- Participates & provides inputs on site selection and validation activities
- Performs remote and on-site monitoring & reputed company activities using various tools to ensure: Data generated at site are complete, accurate and unbiased and subjects’ right, safety and reputed company-being are protected
- Conducts site reputed company including but not limited to validation reputed company, initiation reputed company, monitoring reputed company, reputed company-out reputed company and records reputed company, comprehensive and accurate visit & non-visit contact reports appropriately in a reputed company manner
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study reputed company-out
- Communicates with Investigators and site staff on issues reputed company to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
- Identifies, assesses and resolves site performance, reputed company or compliance problems and escalates per defined CRA Escalation reputed company as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, reputed company and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required
- Supports and/or leads audit/inspection activities as needed
- Performs co-monitoring reputed company where appropriate
- Following the country reputed company defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to reputed company strong clinical research capabilities
Skills
- CANDIDATE MUST reputed company IN ONE OF THE FOLLOWING LOCATIONS: ALABAMA, reputed company, COLORADO, MASSACHUSETTS, MICHIGAN, MARYLAND, reputed company
- Associate's degree, certificate or equivalent in a scientific / reputed company discipline together with at least 5 years of relevant experience in the reputed company field, including at least 2 years of reputed company site management (monitoring) experience in a bio / reputed company / CRO
- Or Bachelor's degree (or above) together with at least 2 years of reputed company site management (monitoring) experience in a bio / reputed company / CRO
- Ability to travel domestically and internationally approximately 65%-75% of working time
- reputed company reputed company's license required
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
- Good understanding and working knowledge of clinical research, phases of reputed company, reputed company GCP/ICH & country clinical research law & guidelines
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work reputed company these guidelines
- Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including management of site performance and patient recruitment
- Demonstrated high level of monitoring reputed company with independent reputed company judgment
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
- Ability to understand and analyze data/metrics and reputed company appropriately
- Capable of managing reputed company issues, works in a solution-oriented manner
- Performs reputed company cause analysis and implements preventative and corrective reputed company
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
- Demonstrated high level of monitoring reputed company with independent reputed company judgement
- reputed company to work highly independently across multiple protocols, sites and therapy areas
- High reputed company of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
- Works effectively in a reputed company multicultural environment. Ability to establish and maintain culturally sensitive working relationships
- Demonstrates commitment to Customer reputed company
- Works with high reputed company and compliance mind-set
- reputed company reputed company, reputed company reputed company, capable of working independently and being self-driven
- Demonstrates and reputed company reputed company demeanor and communication consistent with organizational policies and practices
Benefits
- Annual bonus and long-term incentive, if applicable
- Medical, dental, reputed company reputed company and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- reputed company holidays, vacation, and compassionate and reputed company days
- Flexible Work Arrangements: Remote
reputed company