Clinical Research Associate
Clinical Research Associate
Intellectt Inc
Alameda, CA
See who Intellectt Inc has hired for this role
Role: Clinical Research Associate (CRA) - B
Location: Alameda, CA - 94502
Duration: 6 Months
Essential Duties And Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Kalyan K | Technical Recruiter
Email: Kalyan@intellectt.com
Direct: +1 (732) 769-3893
Desk Number: 732-412-6999 Ext: 274
https://www.intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830
Location: Alameda, CA - 94502
Duration: 6 Months
Essential Duties And Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Conduct single or multi-center medical device clinical studies.
- Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items.
- Participate in study start up activities.
- Responsible for shipping study devices and supplies to clinical sites and performing study device accountability.
- Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements.
- Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
- Maintain and audit Trial Master File to ensure inspection readiness.
- Perform review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed·
- Participate in cross-functional clinical team(s) in the planning and execution of clinical trials.
- Proactively and effectively communicate the status of clinical studies to management.
- Ensures quality delivery of study deliverables within agreed budgets and timelines.
- Participate in the interim and final reviews of study data in preparation of regulatory submissions.
- Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).
- May interact with RA/QA in responding to audits and FDA inquiries.
- BS degree in life sciences or equivalent with minimum 5 years of related experience, or MS degree in life sciences or equivalent with minimum 3 years of experience, or PhD with 2+ years of experience.
- Must have 5+ years of relevant experience in site monitoring, clinical project management, clinical trial practices and regulations.
- Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.
- Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
- Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
- Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
- Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
- Working knowledge of GCP, Clinical and Regulatory Affairs.
- Flexibility in daily activities.
- Proficient with Microsoft Suite.
- Must be able to travel 30-50%
Kalyan K | Technical Recruiter
Email: Kalyan@intellectt.com
Direct: +1 (732) 769-3893
Desk Number: 732-412-6999 Ext: 274
https://www.intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830
-
Seniority level
Associate -
Employment type
Contract -
Job function
Research, Analyst, and Information Technology -
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Intellectt Inc by 2x
See who you knowGet notified about new Clinical Research Associate jobs in Alameda, CA.
Sign in to create job alertSimilar jobs
People also viewed
-
Clinical Trial Management Associate
Clinical Trial Management Associate
-
Part-Time Research Assistant
Part-Time Research Assistant
-
Assistant Clinical Research Coordinator
Assistant Clinical Research Coordinator
-
Junior/Assistant Research Specialist - Ashworth Laboratory
Junior/Assistant Research Specialist - Ashworth Laboratory
-
Clinical Research Coordinator Associate
Clinical Research Coordinator Associate
-
Clinical Research Coordinator
San Francisco Research Institute
-
Clinical Research Coordinator
Clinical Research Coordinator
-
Research Associate I
Research Associate I
-
Clinical Research Coordinator
Clinical Research Coordinator
-
Part-Time Research Assistant
Part-Time Research Assistant
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More