Cedars-Sinai Clinical Research Coordinator II - The Angeles Clinic & Research Institute in Los Angeles, California
The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. We are committed to bringing innovative therapeutic options to all our patients with cancer. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care!
Are you looking to contribute to pioneering research? We look forward to having you join our team to collaborate on groundbreaking research!
The Clinical Research Coordinator II serves as the lead coordinator on an assigned portfolio of research studies, functioning independently to establish and coordinate logistics and processes for the conduct of research for the department. This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols, in compliance with all applicable regulatory requirements.
Primary Duties and Responsibilities
Establishes and executes logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
Coordinates administrative functions of studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, SAE’s and source documents.
Responsible for screening and recruitment of prospective patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
Responsible for accurate and timely data collection, documentation, entry and reporting, including resolution of queries from sponsors or regulatory entities.
Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at research staff meetings.
Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
Plans and coordinates strategies for growing research participant enrollment, and/or improving clinical research efficiency as needed.
Provides technical support for the preparation of grant proposals, publications, presentations and special projects.
Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care and assistance with research participant research billing and reconciliation.
Participate in meetings and conferences related to research activities, including research staff meetings.
Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested; Participates in training and education of new research personnel.
If qualified as a Medical Assistant, may assist with clinical procedures, phlebotomy, providing related patient care when required, including vital signs, EKGs, and specimen collection and testing as directed by physician investigators.
If phlebotomy certified, may assist with phlebotomy services as directed by physician investigators.
Teamwork/Customer Relation Responsibilities
Establishes effective working relationships with cross-functional team(s).
Collaborates to problem solve and make decisions to achieve desired outcomes.
Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups.
Identifies and responds appropriately to both internal and external customer needs utilizing available resources.
Represents the company with external constituents
Assoc. Degree/College Diploma, minimum.
Bachelor's Degree, preferred.
- 3 years of clinical research coordination or related experience, minimum.
Skills, Knowledge and Abilities
Regulatory - Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
Maintains comprehensive knowledge of assigned research protocols to coordinate the compliant execution of assigned tasks in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements.
Technical - Ability to use software applications and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.) MS Office Suite (Excel, Word, Outlook, PowerPoint).
Licenses and Certifications
(BLS)- Basic Life Support Certification needs to be the ARC Healthcare Provider Type Only, minimum.
Certification in Clinical Research- SoCRA or ACRP certification, preferred.
Phlebotomy Certification CA, preferred.
Certified Registered Medical Assistant, preferred.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.