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CHOC Children's · 3 weeks ago

Supervisor, Clinical Research Coordinator, Neonatology

Orange, CA

Full-time

Onsite

Mid, Senior Level

$91K/yr - $149K/yr

6+ years exp

CHOC Children's is committed to being a leading destination for children's health by providing exceptional care. The Clinical Research Coordinator Supervisor is responsible for coordinating multiple clinical research projects, mentoring staff, and overseeing study management and compliance with regulatory requirements.

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Responsibilities

Responsible for the complete coordination of multiple assigned human subjects’ (clinical) research projects

Perform all core Clinical Research Coordinator (CRC) responsibilities

Serve as a mentor, an educator, and a leader with first-line supervisory oversight

Assess feasibility of clinical research protocols

Prepare materials needed for regulatory review and submission to the Institutional Review Board (IRB)

Identify potential study participants

Coordinate and collect research data/specimens

Complete study records in an accurate and timely manner

Participate in quality assurance audits

Manage study materials and supplies

Communicate across multiple teams

Archive records in accordance with appropriate policies and procedures

Responsible for financial components of clinical research projects

Document investigator product (drug or device)

Develop source documents and/or case report forms

Run research/project team meetings

Support investigator-initiated Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications

Monitor or audit studies in the Research Institute

Educate and mentor clinical staff, research team members, and other coordinators

Coordinate multi-center studies

Evaluate CRC performance and assist the Site Manager in resolving operations workload, protocol implementation, and data collection issues

Participate in one or more workgroups or committees within the Research Institute with a focus on CRC operations

Qualification

Clinical research coordinationHuman subjects regulatory knowledgeLeadership experienceMicrosoft Office proficiencyInformed consentResearch sample managementConflict managementPhlebotomy certificationBLS certificationCerner knowledgeInterpersonal skillsEffective communicationDetail orientedTime managementProblem-solving

Required

Minimum six (6) years of clinical research coordination experience

Bachelor's degree or equivalent additional experience can be accepted in lieu of education

Working knowledge of key Microsoft Office programs (Word, Excel, PowerPoint)

Demonstrate strong interpersonal skills

Able to communicate effectively both orally and in writing

Be detail oriented

Able to work under pressure in a fast-paced environment while managing multiple competing priorities

Working knowledge of human subjects' regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for Good Clinical Practice (ICH-GCP)

Ability to conduct informed consent

Strong knowledge of research sample identification, processing, and storage

Ability to manage conflict and to create a culture of accountability within their assigned team

Demonstrate good time and priority management and is capable of problem-solving

Basic Life Support (BLS) - American Heart Association. If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within 6 months of assuming position. With management approval, the time in which to obtain certification may be extended past 6 months due to extenuating circumstances

Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) - If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within 12 months of assuming position. With management approval, the time in which to obtain certification may be extended past 12 months due to extenuating circumstances

Preferred

Clinical research experience in a hospital setting and/or pediatric clinical research experience and demonstrated leadership experience

Master's degree in a relevant field

Working knowledge of Cerner or equivalent electronic medical record system

Phlebotomy certification

Company

CHOC Children's

Glassdoor3.9

Affiliated with the University of California, Irvine, CHOC's growing pediatric healthcare system is comprised of premier facilities, leading-edge programs and services, life-saving research, healing amenities, and education and training programs designed to prepare the next generation of pediatric experts.

Founded in 1985

Orange, California, USA

1001-5000 employees