Clinical Research Specialist II -Dept of Orthopaedics

Job DescriptionThe Clinical Research Specialist II provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and DruThe Clinical Research Specialist II provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).Primary Duties and Responsibilities

Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.

Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.

Coordinates research projects at an institutional or departmental level.

Communicates project status and improvement areas with leadership in a timely manner.

Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.

May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.

Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

Maintains research practices using Good Clinical Practice (GCP) guidelines.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Participates in required training and education programs.

Provides research writing activities such as developing scientific documents for abstracts, publications, presentations, funding applications, and study protocols.

Serves as an internal advisor for specific departmental activities.

Provides guidance regarding project planning, project logistics, and project implementation. Administration (FDA) and local Institutional Review Board (IRB).

QualificationsEducationBachelor’s degree required.Work Experience5 years of experience in area of research specialty. Experience in spine research, training and development of research staff, recruitment strategies and clinical improvement of productivity highly desired.Req ID : 1195Working Title : Clinical Research Specialist II -Dept of OrthopaedicsDepartment : Dept of OrthopaedicsBusiness Entity : Cedars-Sinai Medical CenterJob Category : Academic / ResearchJob Specialty : Research Studies/ Clin TrialOvertime Status : EXEMPTPrimary Shift : DayShift Duration : 8 hourBase Pay : $78,332 - $133,161Cedars-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.