Location
Irvine, CA | United States
Job description
This CRA will plan and execute clinical studies, including but not limited to, protocol & document creation, recruitment, consenting, screening, and conducting study visits. A successful coordinator will be knowledgeable in each of the provided areas but also demonstrate a flexible and enthusiastic mindset in establishing new and creative approaches. This role will require creative and critical thinking, attention to detail, and a strong ability to prioritize efforts.
Essential Duties and Responsibilities: - Partner with Clinical Affairs management to develop and execute clinical studies.
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and client's SOPs
- Execute assigned clinical trials including start up, subject recruitment & scheduling, consenting, screening, subject training, collection of regulatory documents, conducting study visits, performing SMBG testing, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports
- Responsible for identifying and escalating safety events and major protocol deviations
- May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager. May also propose and implement corrective and preventative actions
- Prepare supplies and account for devices required for clinical studies
- Set-up IT equipment for studies
- Complete testing of electronic data capturing systems
- Write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners.
- Incorporate understanding of study objectives and key data points when planning for each assigned protocol
- Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.).
- Communicate effectively and professionally with coworkers, leadership, and study subjects.
- Collaborate with project management to establish and maintain study timelines
- Clearly demonstrate understanding of clinical study management/prioritization
- Manage all clinical tasks and deliverables to meet clinical timeline
- Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.
- Assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision.
- Coordinate preparation of key documents for trial site submission to IRBs.
- Assists management with departmental audits of clinical studies and procedures.
- Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders.
- This position assumes and performs other duties as assigned.
- Complete tasks under minimal supervision.
Experience and Education Requirements: - Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
- Knowledge of GCP (Good Clinical Practice)
- Excellent communication (written and verbal) and presentation skills
- Strong organizational skills and ability to deal with competing priorities
- Strong critical thinking ability with the ability to work independently
- Willing to work, hands-on, in an extremely fast paced environment with high attention to details and accuracy
- Strong interpersonal communication skills and ability to work effectively on cross-functional & global teams
Preferred Qualifications: - Certification as a clinical research associate or coordinator (e.g., CCRA, CCRC)
- Monitoring clinical studies experience or experience as a study coordinator is a plus
- Clinical Trial Management System (CTMS) experience.
- Experience in exercising good judgment in measuring risk vs. business needs
- Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
- Excellent organizational skills, attention to detail and a Data-driven, decision-making mindset
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email
[email protected] for other accommodation options.
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