Senior Clinical Research Associate

Kelly® Science & Clinical is seeking a Senior Clinical Research Asssociate and Manager for a fulltime, direct hire position with a pharmaceutical client in New Jersey.

If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

No C2C

Full-time, perm, direct hire

The Clinical Research Associate (CRA) is responsible for the implementation, monitoring, and summarization of clinical trials in compliance with protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations, and Standard Operating Procedures (SOPs) to ensure patient safety.

Essential Responsibilities :

• Serve as the primary liaison for assigned study sites, conveying project information, answering questions, and resolving site-related issues in accordance with the clinical monitoring plan
• Develop a thorough understanding of study management tasks and responsibilities necessary to comply with protocol / regulatory requirements and applicable SOPs
• Attend Investigator Meetings and study-specific training for assigned trials
• Have comprehensive knowledge of assigned protocol(s) and trial specific manuals / plans to ensure quality and deliverables are met across assigned sites
• Complete pre-study qualification visits, site initiation visits, routine monitoring, and close-out visits within established timelines, documents activities in reports in accordance with applicable SOPs and plans
• Develop and maintain strong collaborative working relationships with clinical investigative sites
• Ensure the trial site’s adequacy and personnel qualifications on an ongoing basis
• Develop and execute corrective action plans at the site level, proportionate to the risks identified
• Accountable for data integrity, patient safety, and regulatory compliance for all assigned sites
• Monitor recruitment and data quality on-site and remotely through systems and communication with sites
• Responsible for ongoing data review and source data verification to study-specific targets and deadlines
• Collaborate with data management to plan and meet data cut and lock deadlines
• Perform on-site drug accountability, reconciliation, and return when applicable
• Verify that trial product receipt, handling, accounting, and storage meets protocol requirements
• Assist the study team in preparation for audits / inspections and is responsible for the quality and completeness of site related performance and documentation

Knowledge & Experience :

• A minimum of 4 5 years of on-site monitoring experience
• Recent experience with remote monitoring or risk-based monitoring preferred
• A minimum of 4 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, Contract Research Organization (CRO), and / or healthcare setting preferred
• Minimum of bachelor’s degree in life sciences or health-related sciences
• Proficient in Microsoft Office suite (Outlook, Word, Excel, and PowerPoint); familiarity with EDC, CTMS, and document management systems
• Overnight travel ranging from 30 80%
• A core understanding of GCP as it relates to clinical trial monitoring
• Demonstrate a core understanding of medical terminology and clinical trial activities in relation to the execution of a clinical development plan
• Oncology experience preferred

Technical and Professional Competencies :

• Excellent written and verbal communication skills; quick learner; able to handle multiple studies and aggressive timelines
• Strong interpersonal skills
• Seeks out opportunities to take on tasks outside of the typical CRA role when required
• Great team player and comfortable working in a small company setting
• Thrives in an entrepreneurial team environment
• Self- Starter able to interact with global scientific, clinical, and marketing teams
• Prioritizes work can rapidly respond to key stakeholders
• Sense of urgency and ability to multitask in chaotic situations
• Responsible and able to rapidly find solutions to issues in difficult situations

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly

Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.

Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals it’s the way we think job searching should be.

Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity.

It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world.

Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.

At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.

Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.