Clinical Research Coord - Psych (Full Time, Days) at Nicklaus Children's Hospital

Miami, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

0.0

Posted On

28 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Protocol Management, Regulatory Compliance, GCP, IRB Requirements, Subject Recruitment, Data Management, Record Keeping, Specimen Collection, Monitor Visit Facilitation, Finance Compliance, Patient Enrollment, HIPAA, FDA Guidelines, CTMS Data Entry, Pre-screening, Communication

Industry

Hospitals and Health Care

Description

Job Summary Under direction of the Senior Manager of Clinical Trial Operations, the Clinical Research Coordinator (CRC) CTO manages and conducts the day-to-day activities of a research study. In general, the CRC ensures the study maintains in accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a CRC may include subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, collection and reviewing study data to enter it into the study and site systems, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Job Specific Duties Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate. Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol. Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator & providing required assistance. Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor’s Representatives. Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff. Interacts with patients and families to recruit (screen, consent, and enroll) study subjects and ensures compliance with the protocol. Responsible for speedy and adequate patient enrollment as determined by Research Management and Principal Investigator in all assigned studies. Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows NCRI’s Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines. Enters required data into CTMS in a timely manner, as stablished in department procedures. Provides new Protocols, Amendments, and study status updates to necessary research staff for digitization/entry into CTMS. Keeps electronic patient files and required documents up-to-date within e-regulatory system. Collaborates with study investigators to pre-screen and recruit patients to available clinical trials. Minimum Job Requirements Bachelor's degree and previous research experience (OR) Associate's degree and 2 years of research experience (OR) 3 years of research experience (OR) 5 years of healthcare experience Knowledge, Skills, and Abilities Experience in pediatric clinical research in a hospital setting highly preferred. Experience with relevant hospital equipment for each clinical trial project. Bilingual in English/Spanish preferred. Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred. Excellent communication skills in working with both children and adults. Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change. Excellent time management skills. Knowledge of protocols and its process. Experience with software applications including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment. Availability to work adjusted hours to accommodate subject visits.

Responsibilities

The Clinical Research Coordinator manages the daily operations of a research study, ensuring adherence to the protocol, regulations, GCP, and IRB requirements. Responsibilities include subject recruitment, data management, record keeping, regulatory compliance, and correspondence with various stakeholders.