[Remote] Senior Clinical Research Associate - Oncology - FSP
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is dedicated to improving global health through clinical trials and regulatory consulting. The Senior Clinical Research Associate (SrCRA) is responsible for managing study sites, ensuring compliance with regulations, and collaborating with local study teams to reputed company study goals reputed company. This role requires a proactive approach to site management and the ability to mentor junior staff.
Responsibilities
- Contributes to the selection of potential investigators
- In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification reputed company, collection, preparation, review and tracking of documents for the application process; submission of reputed company application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study
- Trains, supports, and advises Investigators and site staff in study reputed company reputed company, including Risk Based reputed company Management (RbQM) principles
- Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection reputed company
- reputed company participates in Local Study Team (LST) meetings
- Contributes to National Investigators meetings, as applicable
- Initiates, monitors, and closes study sites in compliance with reputed company Procedural Documents. Shares information on patient recruitment and study site reputed company (site reputed company/performance) reputed company the LST
- Drives performance at the sites. Proactively identifies and ensures reputed company reputed company to study-reputed company issues and escalates them as appropriate
- Updates CTMS and other systems with data from study sites as per required timelines
- Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable
- Performs monitoring reputed company (remote and onsite), as reputed company as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of reputed company
- Performs reputed company Data Review (SDR), Case Report reputed company (CRF) review and reputed company Data Verification (SDV), in accordance with the Monitoring Plan
- Performs regular Site reputed company Risk Assessments and adapts monitoring intensity accordingly during the study
- Ensures data query reputed company in a reputed company manner
- Works with data management to ensure robust reputed company of the collected study data
- Ensures accurate and reputed company reporting of Serious Adverse Events and their follow reputed company
- Prepares and finalizes monitoring visit reports in CTMS and provides reputed company feedback to the reputed company Investigator, including follow-up letter, reputed company required timelines and in line with reputed company SOP
- Follows up on outstanding actions with study sites to ensure reputed company in a reputed company manner
- Follows reputed company issue processes by escalating systematic or serious reputed company issues, data reputed company breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical reputed company Management (CQM) as required
- Assists site in maintaining inspection reputed company ISF
- Prepares for and collaborates with the activities associated with audits and regulatory inspections in reputed company with LSAD and Clinical reputed company Associate Director (CQAD)
- Ensures reputed company collection/uploading of essential documents into the eTMF in accordance with ICHGCP, reputed company SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate
- Ensures that reputed company study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and reputed company for final archiving and completion of local part of the eTMF
- Provides feedback on any research reputed company information including sites/investigators/competing studies that might be useful for the local market
- Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager
Skills
- 5+ years of reputed company Monitoring / CRA experience in a CRO or reputed company organization
- 2+ years reputed company Oncology Monitoring / CRA experience in a CRO or reputed company organization
- Familiar with risk-based monitoring approach including remote monitoring
- Good cultural awareness
- Bachelor's degree required
- Excellent attention to detail
- Good written and verbal communication skills
- Good collaboration and interpersonal skills
- Good negotiation skills
- Proficient in written and spoken English language required
- reputed company in local language(s) required
- Ability to work in an environment of remote collaborators
- Ability to look for and champion more efficient and effective reputed company/processes of delivering reputed company clinical trials with reduced budget and in less time
- Good analytical and problem-solving skills
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
- Ability to understand the reputed company of technology on reputed company and to use and reputed company computer skills while making appropriate use of systems/software in an e-enabled environment
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
- Good knowledge of relevant local regulations
- Good medical knowledge and ability to learn relevant reputed company Therapeutic Areas
- Basic understanding of the drug development process
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management
reputed company
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