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
Pharmaceutical, Biotechnology, Clinical ResearchIndustries
Requirements
- Understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches
- Strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance
- Effective communication skills, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method
Responsibilities
- Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
- Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites
- Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability
- Where required, provide training and support to site staff to uphold these standards and ensure patient safety
- Participate in sponsor and/or Health Authority audits and inspections as applicable
- Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders
- Serve as the organization’s representative for clinical trials at the site level
- Motivate and influence sites to meet study objectives, including enrollment and retention goals
- Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
- Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials
- May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process
- Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators
- Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
- Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable
- Involvement in Regulatory Compliance audit/inspection process, as needed
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What benefits does Bristol Myers Squibb offer?
Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.
Is this a remote position or does it require travel?
This information is not specified in the job description.
What are the main responsibilities of a Senior Clinical Research Associate?
The role involves conducting site qualification, initiation, routine monitoring, and close-out visits; verifying data integrity; monitoring site adherence to ICH GCP and regulations; providing training to site staff; and building relationships with stakeholders.
What is the company culture like at Bristol Myers Squibb?
The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and a focus on work-life balance and flexibility.
What makes a strong candidate for this Senior CRA position?
Strong candidates should have experience in clinical trial monitoring, knowledge of ICH GCP, SOPs, and regulations, the ability to assess investigators and sites, and skills in building relationships and communicating effectively with stakeholders.
Bristol-Myers Squibb
Develops and delivers biopharmaceutical medicines
About Bristol-Myers Squibb
Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.
New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees