Senior Regional Clinical Research Associate
Corcept TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, Pharmaceuticals, HealthcareIndustries
Requirements
- Ability to perform and coordinate all aspects of clinical monitoring and site management
- Capability to conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation
- Knowledge of procedures and guidelines from different sponsors and/or monitoring environments (e.g., FSO, FSP, Government)
- Expertise in acting as a site processes specialist to ensure trial conduct according to approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs
- Skills in ensuring audit readiness and developing collaborative relationships with investigational sites
- Proficiency in risk-based monitoring, including root cause analysis (RCA), critical thinking, and problem-solving to identify site process failures and implement corrective/preventive actions
- Ability to ensure data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review via on-site and remote monitoring
- Competence in assessing investigational product through physical inventory and records review
- Willingness to document observations in reports and letters timely using approved business writing standards
- Capacity to escalate deficiencies and issues to clinical management and follow through to resolution
- Availability for regular contact with sites between visits and overnight travel as needed
- Adherence to approved monitoring plans and participation in investigator payment processes
- Shared responsibility with project team on issues/findings resolution and investigation/follow-up
- Ability to provide trial status tracking and progress update reports to Clinical Team Manager (CTM)
- Proficiency in updating study systems (e.g., Clinical Trial Management System, CTMS) and performing QC checks on CTMS reports
- Participation in investigator meetings and identification of potential investigators in collaboration with clients
Responsibilities
- Monitor investigator sites using a risk-based monitoring approach, applying RCA, critical thinking, and problem-solving to address site process failures and reduce risks
- Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring
- Assess investigational product via physical inventory and records review
- Document observations in reports and letters timely using approved standards
- Escalate deficiencies and issues to clinical management expeditiously and follow through to resolution
- Maintain regular contact with sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording
- Conduct monitoring tasks per the approved monitoring plan
- Participate in the investigator payment process
- Share responsibility with project team on issues/findings resolution and investigate/follow-up on findings
- Provide trial status tracking and progress update reports to the CTM as required
- Update study systems (e.g., CTMS) per agreed conventions and perform QC checks on CTMS reports where required
- Participate in investigator meetings as necessary
- Identify potential investigators in collaboration with the client to ensure acceptability of qualified sites
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this a full-time position?
Yes, this is a full-time permanent position.
What is the work location and travel requirement for this role?
The position is based in the Republic of Georgia with the Clinical Operations team and requires overnight travel dependent on business needs. The environmental conditions are office-based with a standard Monday-Friday schedule.
What key skills are required for the Senior CRA role?
The role requires skills in clinical monitoring and site management, risk-based monitoring with root cause analysis, critical thinking and problem-solving, ensuring protocol compliance with ICH-GCP and regulations, and data review through SDR, SDV, and CRF.
What is the company culture like at Thermo Fisher Scientific?
The company emphasizes meaningful work with global impact, enabling customers to make the world healthier, cleaner, and safer, while providing resources for career goals and fostering collaborative relationships.
What makes a strong candidate for this Senior CRA position?
Strong candidates will have determination to deliver quality and accuracy, expertise as a site processes specialist, and the ability to apply critical thinking, problem-solving, and root cause analysis to ensure compliance and audit readiness.
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees