Clinical Research Coordinator II Job at Solomon Page (Los Angeles)

Clinical Research Coordinator II-OB/GYN

Under minimal supervision, coordinates the clinical assessments of the study sub...

Location

United States , New York

Salary:

63653.84 - 85000.06 USD / Year

Mount Sinai Health System

Expiration Date

Until further notice

Requirements

Bachelors degree in sciences or related field
2 years of clinical research

Job Responsibility

Analyzes moderately complex clinical research data
Assists in interpreting clinical research data
Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects
Prepares and ensures grant applications, IRB/GCO documents are submitted
Ensures accurate and complete compilation of subject data through chart reviews
Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
Obtains informed consent under supervision of the Principal Investigator, Clinical Research Manager, or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies involving genetic tests
Independently obtains informed consent for other clinical studies
Mentors Clinical Research Coordinators in training
Performs other related duties

Human Subject Research Coordinator 1

Under the direct supervision of the Clinical Trial Manager with direction from t...

Location

United States of America , Rochester

Salary:

21.36 - 29.90 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s degree Required
OR Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee Program Required
Or equivalent combination of education and experience Required
Fluent in the Spanish language (verbal & written) Preferred
Prior experience as a Phlebotomist Preferred
Word processing and data analysis software Preferred
Knowledge of word processing, spreadsheets, Red Cap and electronic data capture (EDC) software Preferred
Excellent communication skills, strong attention to detail, and strong interpersonal skills Preferred
Ability to work independently and as part of a team Preferred
Association of Clinical Research Professionals (ACRP) upon hire Preferred

Job Responsibility

Recruits, consents, schedules, and conducts research subject visits for observational studies
Meets with Spanish-speaking patients interested in research after their clinical visit to discuss research opportunities
Recruits and consents subjects to assigned research studies
Schedules and facilitates visits, performing study related procedures as outlined in protocol
May perform testing such as cognitive function tests, depending on protocol
Resolves questions and concerns received from study subjects, triaging to Principal Investigator as necessary
Monitors study progress on a continuous basis
Understands, implements, and provides training on most recent study protocol
Assists Spanish-speaking patients with research visit appointment confirmation and transportation facilitation
Manages the regulatory details for assigned research studies and registries

Fulltime

Clin Research Reg Spt Spec II

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
Fully adheres to applicable safety and/or infection control standards required
Understands and follows data integrity standards and processes required
Ability to effectively manage a higher volume of protocols preferred
Ability to effectively manage moderately complex research protocols/procedures preferred
Possesses a high degree of self-motivation preferred
Recognized ability to function independently preferred
Proficient in managing multiple and competing priorities/demands preferred
Detailed-oriented in record keeping and research documentation preferred

Job Responsibility

Responsible for the coordination and oversight of regulatory requirements of clinical research protocols
Develops increased learned skills, flexibility in performing duties, and assumes responsibility for a portfolio of clinical research protocols under the direction of the Principal Investigator (PI) and senior leaders
Prepares all regulatory documentation, document filing, tracking, and maintenance
Maintains all logs, including OnCore, according to University of Rochester (UR) and department Standard Operating Procedures (SOPs)
Collects all regulatory documents required to submit to the DWG and PRMC and collates essential regulatory documents within Complion
Prepares/drafts ICF and insert institutional language, ensuring language is consistent with protocol
Enters and loads all required documents to OnCore and Complion
Coordinates and validates the delegation log with the applicable DWG clinical research staff
Prepares and tracks submission to Institutional Review Board (IRB) (CIRB, RSRB, Commercial IRB), FDA, ClinicalTrials.gov, etc
Maintains regulatory records and necessary correspondence records

Fulltime