Clinical Research Coordinator

Grand Institute of Health
1001 E Grand Ave
Escondido, CA 92025, USA

Grand Institute of Health
1001 E Grand Ave
Escondido, CA 92025, USA

Neighborhood is a private, non-profit 501(C) (3) community health organization. We serve over 500,000 medical, dental, and behavioral health visits from more than 100,000 people annually. We pursue our mission to improve the health and happiness of the communities we serve by providing quality care to all, regardless of situation or circumstance.

Since 1969, our employees have been making this mission a reality. Regardless of the role, our team focuses on being compassionate, having integrity, being professional, always collaborating, and consistently going above and beyond. If this sounds like an organization you would like to be a part of, we would love to meet you.

The Clinical Research Coordinator will collaboratively work with the Principal Investigators (PI), sub-investigators, clinical, and ancillary departments to assist with research studies. This role will help with collecting data, material, and supplies for successful studies results. Additionally, this role will provide administrative support to the clinical research team to ensure processes are running efficiently.

Schedule:
Monday-Friday: 8am-5pm. This is an onsite position.

Clinical Trial Administration & Operations

• Assists with organizing and scheduling assessments, tests, and activities to meet research objectives and study protocol compliance
• Communicates with study team personnel to ensure study procedures are followed and research is performed as described in protocols
• Serves as contact for subjects, study personnel, Institutional Review Board (IRB) and study sponsor
• Assists with assessing patient eligibility and coordinating study participant activities, including recruitment, screening, orientation, and correspondence
• Schedules appointments, tests, and procedures coordinating with external providers for subjects, as needed
• Generates reports and other materials for studies, as directed
• Assists with data collection for research studies by following established data collection and management procedures, including collecting, recording, entering, and preparing data for analysis
• Collects pertinent information from study participants through interviews, tests, surveys, questionnaires, medical records reviews, or other collection procedures to perform preliminary study analysis with Principal Investigator or senior coordinators
• Maintains accurate, complete, and timely records, including source documents, consent forms, case report forms, protocol documents, and regulatory documents according to sponsors and institutional guidelines
• Assists with submission of timely, accurate, and complete study continuing review, amendments, and reportable events to IRB

Ensures consent processes are performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsors, and institutional regulations and policies

Provides ongoing education to study subjects about clinical trials, including significant new information that may affect a subjects willingness to participate in a study, as need

Evaluates and promotes subject compliance with more education

Assists in the preparation of sites for monitor visits and external/internal audits, including providing timely responses to queries from sponsor and/or auditors

Collaborates with pharmacist or materials management personnel to maintain accurate accountability of investigational products and specimens

Assists with sample collection, processing, and shipment for each study

Updates automated databases and other records for reporting and compliance purposes

Generates reports and analysis of data according to project schedules and/or on an ad hoc basis

Assists by arranging and attending meetings, seminars, symposiums, and other events related to project efforts

Participates in educational opportunities to increase knowledge about clinical trials and regulations, including staying abreast with current federal, state, and institutional regulations and best practices

Orders supplies and equipment, including researching and developing recommendations for new equipment purchases

• Attends meetings and trainings, as required
• Maintains professional working relationships with all levels of staff, participants, patients, and the public.
• Cooperates in accomplishing department goals and objectives

• High school/GED required; bachelor’s degree preferred
• Valid CA Certified Nurse Assistant or Medical Assistant certification required;
  Licensed Vocational Nurse license preferred
• Three years of experience working within the healthcare setting required
• Certified Research Professional (CCRP or CCRC) or one year research experience preferred
• Valid Human Subjects Protection or Good Clinical Practice certification required or ability to obtain within 90 days of employment
• Current Basic Life Support (BLS) certification is required upon hire and must be maintained as a condition of…