One of our clients is looking for a talented and highly motivated Clinical Research/Trials Analyst. Please send your resume if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.

Here are the job position details for your review:

Job Title: Clinical Research/Trials Analyst
Pay Rate: $40 to $48.85/HR
Duration: 12 Months
Location: Orange County, CA (Onsite 4 days a week)

Shift 1- 8 AM to 5 PM Pacific time

Our Client is a Global medical device Manufacturer.

We are looking for a Clinical Research/Trials Analyst

Summary:
As the Clinical Operations Analyst for our THV Core Labs team, you will be responsible for providing project management of dynamic and high-volume core lab projects across all THV global clinical studies to ensure accurate and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to data management teams to ultimately provide unbiased study results.

Key Responsibilities:

• Analyze the clinical output of moderately complex studies and provide a high-level summary with supporting details of study trial status (e.g., Core Lab image perspective) to stakeholders and clinical management
• Identify technical and data issues and collaborate with appropriate team members to bring to resolution; assist in the determination of root cause and recommend and implement corrective actions
• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., open information requests, ageing issues, the status of the image analysis from Core Labs to study database, etc.)
• Develop basic timeline assessment and/or work with senior-level team members on complex timeline assessment (e.g., clinical site through Image workflow vendor to Independent Core Lab) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines
• Provide guidance and represent the department to communicate risk and impact to study the core team's key milestones and deliverables
• Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff

Requirements:

• Bachelor's Degree in STEM or healthcare
• 3 years of hands-on clinical research experience
• Clinical trial/research background with medical devices. If in a cardiovascular or clinical imaging setting, a huge plus!
• Track record of supporting 3 or more ongoing trials at one time.
• Recent work experience with EDC Rave.
• Highly skilled in Excel & SharePoint.
• Experienced with interpreting clinical data.
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with ERP software, JDE and CTMS (Clinical Trial Management System) preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Ability to work in a fast-paced environment
• Substantial knowledge and understanding of our policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• Good problem-solving skills
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Must be able to work in a team environment under minimal supervision
• No instructions are needed on routine work, and general instructions are given only on new lines of work or special assignments
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control

Soft skills to target:

• Must be a team player, this group is highly collaborative.
• Highly organized.
• Proven communicator.

Job Type: Contract

Pay: $40.00 - $48.85 per hour

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Day shift

Application Question(s):

• This is a W2 position, Are you ok to work on W2?
• Please provide your email address

Education:

• Bachelor's (Required)

Experience:

• Clinical trial/research/study: 2 years (Required)
• EDC/Medidata Rave: 3 years (Required)
• CTMS/Veeva Vault/OpenClinica: 3 years (Required)
• Excel/SharePoint/ERP/JDE: 3 years (Required)

Ability to Commute:

• Irvine, CA 92614 (Required)

Work Location: In person