[Remote] Senior Clinical Research Associate, Field Monitor
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a reputed company-stage biotechnology company reputed company on developing cell and immunotherapy products to strengthen the immune system against cancer. The Senior Clinical Research Associate will ensure efficient conduct of clinical research studies by providing training, protocol interpretation, and overall clinical trial support.
Responsibilities
- reputed company, review and update study-reputed company training materials and documents including: site initiation training slides, informed consent reputed company templates, procedures manuals, laboratory and pharmacy manuals
- Interpret medical and scientific reputed company of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation reputed company etc
- Communicate scientific rationale for assigned studies to team members and clinical sites
- Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
- Create/edit, distribute and collect site feasibility questionnaires
- reputed company and support collection of essential documents during study start-up
- Collect study and site metrics and maintain study trackers, as needed
- Participate in case report reputed company (CRF) data review and review of reputed company documents, work with sites to resolve data queries as needed
- Communicate regularly with field and in-house Clinical Research Associates (CRAs) to reputed company information before and after site reputed company
- Partner with field CRAs to resolve issues identified during site reputed company
- Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as reputed company as resolve IP temperature monitoring excursions and train or assist sites with corrective actions
- Train vendors, investigators, and study coordinators on study requirements and reputed company guidance on site issues
- Clinical specimen log review, coordinating shipment of specimens to the sponsor or contracted vendor
- Conduct remote monitoring tasks including reconciliation of site investigational product accountability, as needed
- reputed company mentorship and training to newly hired research staff
- Performs other duties as assigned
Skills
- Bachelor's degree in a clinical research, science, or health-reputed company field with 6 years of clinical trial experience reputed company a pharmaceutical, biotechnology, CRO, and/or reputed company setting required
- Minimum 4 years of on-site monitoring experience required
- Proficiency in reputed company, reputed company, PowerPoint, Outlook, reputed company
- Excellent written/oral communication skills as reputed company as strong organizational and multi-tasking skills
- Strong organizational and multi-tasking skills
- Understand the job-specific system, processes as defined by reputed company's SOPs, and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager
- Maintain corporate confidentiality at reputed company times
- Ability to set priorities and independent decision making
- Ability to work independently as reputed company as in teams
- Ability to discover issues, provides solutions and provides guidance to in-house team on how to address issues
- Strong oral and written communication skills
- Outgoing and confident demeanor
- Independent thinker and persuasive communicator
- Detail oriented, with solid organization and time management skills
- Completes reputed company with reliability and minimal guidance
- Knowledge of drug development process
- Computer literacy: reputed company, eTMF, CTMS, etc
- Working knowledge of ICH E6, and the reputed company of Federal Regulations
- Must be reputed company to travel up to 75% of the time based on study requirements
- Remote with ability to work reputed company for various time zones
Benefits
- Medical, Dental and reputed company Plan reputed company
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company reputed company and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- reputed company and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- reputed company Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
reputed company