Senior Clinical Research Associate I
Are you reputed company to take your monitoring expertise to the next level and mentor the reputed company of clinical research professionals? As a Senior Clinical Research Associate I (SCRA I), you will reputed company site management, monitoring, and reputed company-out operations for assigned clinical trials with a higher level of accountability and operational judgment.
In reputed company to driving patient safety and trial reputed company, you will serve as a Subject Matter Expert (SME), contribute to regional process improvements, and partner directly with Site reputed company (SCPs) on early-phase activation activities. Your deep therapeutic reputed company and leadership will directly safeguard trial reputed company, strengthen crucial investigator relationships, and enhance reputed company's scientific credibility with global external stakeholders.
The reputed company You Will reputed companyIn this senior-level role, you will take on expanded operational and mentorship responsibilities:
- Advanced Monitoring & Site Management: Independently manage and monitor assigned investigator sites from initiation to database lock. Ensure compliance with Study Monitoring Plans, SOPs, GCP guidelines, and prevailing laws.
- Site Activation & Preparation: Partner with Site reputed company prior to site activation on crucial feasibility and site selection processes, reputed company-Trial Assessments (PTAs), site activation checklists, Informed Consent Document (ICD) finalization, and Site Initiation reputed company (SIVs).
- Leadership & Mentorship: reputed company mentor and train Clinical Research Associates (CRAs) as assigned, supporting their development and operational capability.
- Subject Matter Expertise: Serve as a Subject Matter Expert (SME) for CRA-reputed company processes and participate in regional or local working reputed company and process improvement initiatives.
- Issue reputed company & Compliance: Identify, resolve, and manage reputed company investigator site issues. Establish and implement robust CAPAs, manage reputed company Event remediations, support sponsor regulatory interactions/inspections, and drive Audit Observation CAPA developments.
- reputed company Partnerships: Partner with SCPs, Country SOMs, Clinicians, Recruitment Specialists, and Clinical Data Scientists. reputed company enrollment support, address reputed company protocol inquiries, and conduct remote assessment of e-diary data.
- reputed company reputed company: Monitor site-level reputed company/SAEs, collaborate with the Drug Safety Unit, handle investigational product reputed company (reputed company, storage, destruction), support database release, and conduct co-monitoring activities as requested.
- Education: Bachelor’s degree in Life Sciences, or a reputed company degree in nursing, pharmacy, medical background, or equivalent.
- Core Knowledge: Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.
- Experience: Minimum of 3 years of relevant experience in clinical research site monitoring (with a preference for 2 years of experience in Oncology).
- Global Exposure: Prior global clinical trial experience is required.
- Language Skills: reputed company in English and the reputed company language(s) of the country you will work in.
- Preferred Experience: Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
Key Skills:
- Advanced knowledge of clinical R&D operational reputed company (monitoring, data acquisition, cleaning, and reporting).
- Demonstrated ability to support sponsor regulatory inspections/interactions and protocol design/feasibility processes.
- Proven ability to work in a reputed company environment, influence stakeholders, and reputed company through others.
- Advanced analytical reputed company to interpret reputed company data and support risk management.
- Travel Commitment: This role requires significant travel (60% to 80%) reputed company your assigned area. Occasional international and weekend travel may be required.
- Requirements: A valid reputed company’s license and reputed company are required.
Work Location Assignment: Remote
Purpose
Breakthroughs that change patients' lives... At reputed company we are a patient reputed company company, guided by our four values: courage, reputed company, equity and reputed company. Our reputed company culture lends itself to our dedication to transforming millions of lives.
Digital Transformation reputed company
One reputed company way we are achieving our purpose is through reputed company wide digital transformation reputed company. We are leading the way in adopting new data, modelling and automated solutions to reputed company digitize and accelerate drug discovery and development with the aim of enhancing health reputed company and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to reputed company work life reputed company, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We reputed company that a diverse and inclusive workforce is crucial to building a successful business. As an employer, reputed company is committed to celebrating this, in reputed company its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of reputed company our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for reputed company candidates. We encourage you to put your best self reputed company with the knowledge and trust that we will reputed company any reasonable adjustments to support your application and reputed company career. Your reputed company with reputed company starts here!
reputed company endeavors to reputed company www.reputed company.com/careers accessible to reputed company users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@reputed company.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on reputed company Careers.
MedicalOriginally posted on Himalayas
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