Clinical Research Coordinator

Job Description

Job Description

About Us

Community health is about more than just vaccines and checkups. It’s about giving people the resources they need to live their best lives.

At Neighborhood, this is our vision. A community where everyone is healthy and happy. We’re with you every step of the way, with the care you need for each of life’s chapters.

At Neighborhood, we are Better Together.

As a private, non-profit 501(C) (3) community health organization, we serve over 500,000 medical, dental, and behavioral health visits from more than 96k people annually.

We do this in pursuit of our mission to improve the health and happiness of the communities we serve by providing quality care to all, regardless of situation or circumstance.

We have been doing this since 1969 and it is our employees that make 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 that sounds like an organization you want to be a part of, we would love to have you.

ROLE OVERVIEW and PURPOSE

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.

RESPONSIBILITIES

Clinical Trail 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

Team Support :

• 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

EDUCATION / EXPERIENCE

• 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’ 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

ADDITIONAL QUALIFICATIONS (Knowledge, Skills and Abilities)

• Excellent verbal and written communication skills, including superior composition, typing and proofreading skills
• Ability to interpret a variety of instructions in written, oral, diagram, or schedule form
• Knowledgeable about and experience with protocol design, management, and FDA regulations
• Knowledgeable about and experience with medical research terminology
• Ability to use web applications and Microsoft applications
• Ability to manually data collect and use spreadsheets
• Ability to solve problems and self-manage
• Ability to successfully manage multiple tasks simultaneously
• Excellent planning and organizational ability
• Ability to work as part of a team as well as independently
• Ability to work with highly confidential information in a professional and ethical manner

Physical Requirements

• Ability to lift / carry 10 lbs / weight
• Ability to stand for long periods of time

COMPLIANCE (Safety & HIPPA)

• Follows all safety procedures as outlined in Neighborhood Healthcare’s Illness and Injury Prevention Plan (IIPP) and report any injuries and / or unsafe conditions immediately
• Maintains current knowledge of policies and procedures as they relate to safe work practices
• Follows all safety procedures and report unsafe conditions
• Uses appropriate body mechanics to ensure an injury free environment
• Familiarity with location of nearest fire extinguisher and emergency exits
• Follows all infection control procedures including blood-borne pathogen protocols
• Maintains privacy of all patients, employee and volunteer information and access such information only on a need-to-know basis for business purposes
• Complies with all regulations regarding corporate integrity and security obligations
• Reports all behavior and / or activity that are unethical, fraudulent, or unlawful

Neighborhood Healthcare offers a generous benefit plan that includes : Partially company paid Medical, Dental, and Vision Plans.

Two plus weeks of vacation, Nine Holidays including two Floating Holidays of your choosing, Sick / Personal time, Volunteer Time Off (VTO), 403b Retirement plan (similar to a 401k), optional Health and Wellness events, and much more!

Pay range : $24.63 - $34.86 per hour, depending on experience.