Senior Regional Clinical Research Associate
Corcept TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years)
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, PharmaceuticalsIndustries
Requirements
- Applies root cause analysis (RCA), critical thinking, and problem-solving skills
- Knowledge of ICH-GCP and applicable regulations
- Ability to conduct on-site and remote monitoring activities (SDR, SDV, CRF review)
- Proficiency in approved business writing standards for reports and letters
- Willingness to travel more than 75%
- Ability to maintain regular contact with investigative sites between visits
- Competence in administrative tasks (e.g., expense reports, timesheets)
Responsibilities
- Monitors investigator sites using a risk-based monitoring approach, identifying site process failures and corrective/preventive actions
- Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote activities
- Assesses investigational product via physical inventory and records review
- Documents observations in reports and letters timely; escalates deficiencies to clinical management and follows through to resolution
- Maintains regular contact with sites between visits to confirm protocol adherence, issue resolution, and timely data recording
- Conducts monitoring tasks per the approved monitoring plan
- Participates in investigator payment process and shares responsibility for issues/findings resolution
- Investigates and follows up on findings
- Participates in investigator meetings and helps identify potential investigators
- Initiates clinical trial sites per procedures, ensuring protocol, regulatory, and ICH-GCP compliance
- Performs trial close-out and retrieval of trial materials
- Ensures essential documents are complete per ICH-GCP and regulations; conducts on-site file reviews
- Provides trial status tracking and progress update reports
- Ensures study systems (e.g., Clinical Trial Management System) are complete, accurate, and updated
- Facilitates communication between sites, client, and project teams via written, oral, or electronic means
- Responds to company, client, and regulatory requirements/audits/inspections
- Maintains and completes administrative tasks timely
- Contributes to project team by assisting in publications/tools preparation and sharing ideas
- Contributes to other project work and process improvement initiatives
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the work schedule for this CRA position?
The work schedule is standard Monday through Friday.
Is remote work available for this role?
This information is not specified in the job description.
What are the key skills required for this CRA role?
Key skills include risk-based monitoring, root cause analysis, critical thinking, problem-solving, data review through SDR/SDV/CRF, and knowledge of ICH GCP regulations.
What is the travel requirement for this position?
Travel requirement is higher than 75%.
What salary or compensation is offered for this CRA role?
This information is not specified in the job description.
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