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20 days old

Clinical Research Associate

Kelly Services
West Hollywood, CA 90069
**Clinical Research Associate**

(Remote Monitoring - Part Time Contract)


Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We currently have exciting opportunities for a par time Remote Monitoring CRA to work with a oncology CRO directly supporting their clinical trials as a Clinical Research Monitor. This opportunity will average 16 hours part time for 3-4 months and have the potential to convert to permanent with our client if interested at that time. Staying contract is also an option.


**Job Description:**


This position is responsible for independently monitoring clinical trial data in accordance with Good Clinical Practices (GCP), ICH, FDA, and internal standard operating procedures (SOPs). The CRA will conduct site visits to assess protocol and regulatory compliance while ensuring patient safety. This includes source document verification, regulatory document review and management, and drug accountability. As a CRA, you will be the primary liaison between the sites and our company, ensuring questions are answered and issues resolved. You must clearly demonstrate the ability to manage multiple projects. This position is primarily responsible for remote monitor visits.


**ESSENTIAL DUTIES AND RESPONSIBILITIES:**


+ Review the performance of the trial at designated sites.

+ Ensure the rights and well-being of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

+ Ensure the quality and integrity of the reported data on case report forms (CRFs) by careful and thorough source documentation review. Generate queries and assist sites with resolution.

+ Track and follow serious adverse events (SAEs) ensuring timely reporting to appropriate entities.

+ Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents.

+ Reviews the completeness and quality of the investigator site file (ISF). Collects and reviews essential documents.

+ Prepare accurate and timely trip reports while documenting visit findings.

+ Assists in resolving any issues to ensure compliance. Escalating issues to Clinical Project Manager, as necessary.

+ Maintain regular communication with sites.

+ Conduct all aspects of site monitoring of clinical research studies according to Standard Operating Procedures, ICH Guidelines and GCP.

+ Perform other duties as assigned by Project Manager.


**KNOWLEDGE & SKILLS**


+ Ability to perform all clinical monitoring activities independently.

+ Ability to manage multiple tasks, unpredictable scenarios and achieve project timelines.

+ Strong knowledge in electronic data capture (EDC) systems.

+ Must be able to work independently as well as establish and maintain effective working relationships with co-workers, supervisors, and other staff. Excellent interpersonal abilities required.

+ Basic medical/therapeutics area knowledge and understanding of medical terminology.

+ Must have thorough knowledge of clinical research concepts, practices, and FDA regulations and ICF Guidelines regarding drug development phases, clinical research, and data management methods.

+ Ability to maintain a working knowledge of multiple study protocols.

+ Ability to solve problems. Must have effective time management, organizational skills, and superior attention to detail.

+ Read, write, and speak fluent English. Excellent verbal and written communication skills.


**EDUCATION & EXPERIENCE**


+ Bachelors degree in a scientific discipline

+ Minimum of two years' experience in clinical research monitoring (prefer experience in remote monitoring from home office)

+ Therapeutic experience in oncology, preferred

+ Must have CRO or sponsor study monitoring experience as a CRA


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-29 Expires: 2022-08-29

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Clinical Research Associate

Kelly Services
West Hollywood, CA 90069

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