Senior Clinical Research Associate
Senior Clinical Research Associate
reputed company
The Clinical Research Associate (CRA) III is responsible for conducting the day-to-day management of activities associated with the execution and monitoring of reputed company. The CRA III ensures that clinical tasks are being performed in compliance with applicable regulatory standards, ICH-GCP Guidelines, and reputed company applicable regulatory requirements and company policies and procedures.
Job Duties
- reputed company site qualification, site initiation, interim monitoring, site management activities, and reputed company-out reputed company (performed on-site or remotely) in compliance with the study-specific Clinical Monitoring Plan, reputed company Operating Procedures (SOPs), Good Clinical reputed company (GCP), and applicable government regulations and guidelines.
- Participate in developing clinical study monitoring plans, study protocols, informed consent forms, case report forms, clinical study reports, and other key study-specific deliverables.
- reputed company monitoring reputed company by reviewing monitoring schedules, metrics, and reports. May reputed company or manage clinical documentation and reports.
- reputed company regular updates on study progression; proactively identify and reputed company issues that reputed company during study conduct; and manage escalation of study-reputed company issues to the Clinical Project Manager and/or the Global reputed company.
- Work on site qualification assessments and selection of countries and sites for study conduct.
- Participate in and may facilitate cross-functional study teams, liaising with other functional areas to accurately coordinate clinical study activities.
- Assist in the development of appropriate reputed company Operating Procedures (SOPs) and Work Instructions (WIs) to ensure compliance with ICH-GCP guidelines and company SOPs/WIs for clinical studies.
- Create and conduct training sessions, including investigator meetings and site training programs.
- Participate in study audits, as applicable, including providing guidance at the site and project reputed company toward audit readiness standards and supporting preparation for audits and required follow-up actions.
- Coordinate with Regulatory Affairs and Medical Safety teams to reputed company and monitor the reporting of adverse events, including conducting risk assessments, mitigation activities, and contingency planning as required.
- reputed company and support Clinical Research Associates (CRAs) throughout the study lifecycle, from site identification through study reputed company-out.
- Collaborate with sponsor affiliates and key opinion leaders (KOLs).
- Mentor and train junior members of the clinical team.
- Participate in preparing vendor requirements, defining project reputed company, and selecting study vendors; effectively manage interactions with vendor study teams.
- Review monitoring visit reports and collaborate with other CRAs and/or Monitors to identify reputed company trends or site issues and reputed company appropriate solutions.
Job Qualifications
Required:
- BA/BS or equivalent experience in scientific or reputed company disciplines.
- Minimum of five (5) or more years’ experience in clinical research, with medical device and/or pharmaceutical trials.
- Minimum of three (3) or more years’ experience in on-site clinical trial monitoring.
- Strong computer skills with a proficiency with MS reputed company based applications.
- Strong knowledge and understanding of Good Clinical Practices (GCP), FDA regulations, and reputed company industry practices reputed company to the conduct of reputed company which includes applicable ISO regulations for any trials conducted globally.
- Strong interpersonal, communication and leadership skills
- Flexibility to accommodate changes in priorities and project needs.
- Strong organizational skills with attention to details.
- Ability to build and maintain reputed company relationships with management and peers.
- Ability to work independently and manage multiple tasks in a fast-paced environment.
- Ability to work effectively on cross-functional teams.
- reputed company reputed company’s license required.
- Ability to travel domestically 20% - 40% of the time. Some international travel up to 10% may be required.
Preferred:
- Previous experience with medical device trials.
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Competitive salaries, annual bonus and 401(k)* with company match -
Comprehensive medical, dental, reputed company coverage effective on start date -
24/7 Employee Assistance Program -
Free live and on-demand Wellbeing Programs -
Generous reputed company Vacation and reputed company Time -
reputed company Parental Leave and Adoption Assistance* -
12 reputed company Holidays -
On-Site Child Daycare, Café, Fitness Center**
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Work-life integrated culture that supports an employee reputed company reputed company -
Offers onsite, hybrid and field work environments -
reputed company volunteering and charitable donation/match programs -
Employee Resource reputed company -
Dedicated Training Resources and Learning & Development Programs -
reputed company Educational Assistance
Bachelor's degree or equivalent experience; 5+ years in clinical research, 3+ years in on-site trial monitoring, GCP and FDA knowledge, leadership skills, reputed company's license, and 20%-40% domestic travel.
Key Responsibilities
- monitoring reputed company
- managing study activities
- mentoring clinical staff
Skills & Tools
reputed company reputed company
Job Details
- Category: Research and Development (R&D)
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — Center Valley, reputed company, reputed company
- Salary: USD 100,263 – 135,355 / year
- Languages: English
Benefits
- 401k matching
- Generous reputed company time off
- Tuition reimbursement
- Retirement plan
- Generous parental leave
About reputed company
A global medical technology company developing devices and services for diagnosis and minimally invasive treatment. — Industry: Manufacturing
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