Lead Clin Research Coordinator (Full Time, Days)

Provides guidance, training, and mentorship to Clinical Research Coordinators, Research Assistants and/or other support personnel.

Job Specific Duties

• Serves as a subject-matter expert and resource for the research team on the compliant conduct of assigned studies.

• Facilitates communication between investigators and Clinical Research Coordinators on subject-matter or technical matters.

• Oversees study conduct including all support data collection for study start-up activities.

• Oversees collection, maintenance, and reporting of accurate patient data for submissions to sponsors, maintaining patient records, and coordinating the collection and shipments of specimens as required by protocol.

• Reviews and confirms subject study eligibility with PI/Sub-I of assigned studies.

• Oversees study registration, patient screening/enrollment, and overall study requirements.

• Registers and enrolls research participants.

• Aggregates, tracks, trends, and reports research study and patient screening/enrollment data as required.

• Interacts with patients and families to recruit (screen, consent, and enroll) study subjects and ensures compliance with the protocol.

• Complies with the Research Finance Compliance policies and procedures including time and effort reporting for grants.

• Submits protocol amendments and other documents requiring IRB submission to the Research Regulatory Affairs team and notifies CTMS support staff for protocol digitization.

• Enters Research Patient information into CTMS within 72 hours of enrollment, patient visit, or patient-related event.

• Pre-screens potential research participants and enters information into CTMS within real time (if possible) or within 24 hours.

• Compiles accurate CTMS metrics data for updating SAC CTO slides and runs weekly enrollment reports for management review.

• Updates study statuses in CTMS and ensures study enrollment changes are communicated to Research Regulatory Affairs team and CTO Management.

• Attends meetings with Research management, research team, and/or PI/Sub-Is and is prepared to discuss research portfolio and/or patient status.

Qualifications

Minimum Job Requirements

• Bachelor's Degree Bachelor's degree or higher and 5 years of research experience (OR) 9 years of research experience. (Required)

• Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 16 months in position

Knowledge, Skills, and Abilities

• Bachelor's degree in Nursing (BSN) and/or current RN licensure strongly preferred.

• Ability to train, guide, and mentor peers.

• Knowledge of rules and regulations governing the designated research.

• Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems.

• Bilingual in English/Spanish.

• Excellent communication skills in working with both children and adults.

• Software applications experience including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.

• Experience with relevant hospital equipment for each clinical trial project.

• Experience working on clinical trials, interventional studies all phases.

• Advanced knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Ability to respond calmly under stressful conditions.

• Ability to maintain confidentiality of sensitive information.

• Ability to effectively work in a team.

• Excellent time management and interpersonal skills.

Job

Research

Department

Ri - administration-2100-380950

Job Status

Professional