Adecco
Location
Carlsbad, CA | United States
Job description
Adecco is currently assisting an American supplier of scientific instrumentation, reagents and consumables, and software services for a Clinical Affairs Associate job in Carlsbad, CA.
This Remote contract position is part of the Regulatory and Clinical Affairs organization. Your work will impact the quality of the FDA submissions and help secure the necessary approvals for our products to be marketed and reach the patients who will ultimately benefit from these diagnostics.
Schedule: M-F, 40hrs
Pay Rate: The wage for this position is between $40 and $52. Hourly wage may depend upon experience, education, geographic location and other factors.
Key Objectives of the role:
Coordinating and conducting activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics
Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements
Collect all clinical study essential documents
Ensure that CRO activities and timelines are in coordination with project requirements
Implement and document communication with CRO and laboratories to ensure project progress
Real time escalation of Clinical studies issues to Clinical Study Managers
Ensure compliance with company SOPs
Assist in performing remote lab assessment visits.
Minimum Qualifications:
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
Working knowledge of Good Clinical Practices is required.
Certification as a Clinical Research Professional (CCRP) is a plus
If certification is not in place, class work/ course work in Good Clinical Practices is required.
Minimum of 2 years working in the In Vitro Diagnostic or Medical Device Industry. In Vitro diagnostic experience is a plus.
A Minimum of 2 years demonstrated experience in supporting the management of in house and/or external clinical studies.
Experience working with multi-functional project teams is required.
Computer literacy, including spreadsheet, database and word processing applications required.
Ability to adjust schedule in order to work with multiple time zones.
Candidate must be an independent professional who proactively communicates frequently and effectively.
Must be comfortable working on projects where the project and its team members may be located at other sites.
Should be at ease with direct communication with internal project team members and external CROs .
Should be organized and able to work to on multiple projects with tight deadlines.
High energy level; positive attitude; works well under stress; assertive and effective communicator.
Hands-on, action-oriented, and able to implement effectively.
Click on apply now for instant consideration!
This employer requires all employees, temporary labor, consultants, and contractors to be fully vaccinated against COVID-19 by their start date, subject to approved medical or religious exemptions.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.
Pay Details: $40.00 to $52.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.Job tags
Salary
$40 - $52 per hour
