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Research Assistant/Clinical Research Coordinator

1 month ago


Los Angeles, United States Mens Health Foundation Full time
Job DescriptionJob Description

Are you in search of a fulfilling and meaningful position? Do you want to work for an organization that promotes growth and development?

Here at Men's Health Foundation, we envision a world where inequity and stigma do not separate people from healthcare.


"Reimagining Healthcare" is our commitment to affirming the unique experience of every patient. We prioritize our patients’ evolving needs and strive to help each patient feel comfortable, understood, and respected.



Why Men's Health Foundation?

Men's Health Foundation is seeking compassionate, mission-driven individuals. We believe that by reimagining how healthcare is delivered, we can help create greater health equity for those most at risk, breaking down barriers to care. We welcome all backgrounds, gender identities, and expressions.

We recognize our staff as the heart of our organization and seek to provide a generous and competitive benefits package to support our employee's well-being. We offer the following:

  • Medical, Dental, Vision, Life and LTD insurance (may be eligible on the 1st of the month following date of hire)
  • 11 Paid Holidays + 1 mental health day
  • 401(k) Retirement plan (may be eligible for employer matching up to 4% following completion of 90th day of employment)
  • Flexible Spending Account (FSA)
  • 40 hours of sick pay (following completion of 90th day of employment)
  • 120 hours of PTO accrued within the 1st year of employment

We seek team members who embrace and champion diversity, as our work within the LGBTQ+ community promotes positive sexuality and inclusivity. Candidates should be comfortable with exposure to imagery, events, and materials that reflect our culture of acceptance and expression, ensuring alignment with our values.

OVERVIEW

The Clinical Research Coordinator will work under the guidance of the Principal Investigator, Sub-Investigators, and/or Director/Manager of Clinical Research Operations to participate in the planning, implementation, and overall direction of clinical research projects conducted on behalf of the sponsors at the institute. You will perform study procedures, transcribe source data to case report forms, and liaise with sponsor personnel, maintaining a high level of professional expertise through familiarity with the study protocol, investigator’s brochure, related study materials, standard operating procedures and policies, and participation in project team meetings. Ensuring research quality by practicing compliance and following the principles of Good Clinical Practice (GCP)/International Harmonization Conference (ICH), Health Insurance Portability and Accountability Act (HIPAA), Federal Drug Administration (FDA) policies and guidelines, and other applicable regulations (state and local).

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

(This list may not include all the duties assigned.)

  • Applying knowledge of study design and flow chart to evaluate protocol feasibility at the research site and developing strategy for implementing study procedures in compliance with study protocol.
  • Preparing and submitting documents to institutional review board, attending and participating in investigator meetings as directed, and initiating query requests to sponsors for the study.
  • Recruiting and screening research participants to evaluate eligibility for a clinical study by reviewing medical record source documents, inclusion/exclusion criteria, and participants’ willingness and capability to follow required clinical research procedures, processes, and follow-up appointments.
  • Obtaining informed consent documentation from research participants prior to any study-related procedures, maintaining patient screening enrollment logs, and following randomization procedures per protocol, ensuring protection of patients' confidentiality and privacy during initial and follow-up interviews and visits.
  • Dispensing study drugs per protocol, reviewing participants' diaries and questionnaires as appropriate, and collecting, batching, and shipping specimens as required.
  • Adhering to HIPAA requirements when transmitting data via fax, mail, or electronically as requested by the sponsor or CRO, and resolving data queries and maintaining files for all study-related documentation.
  • Completing and maintaining all study drug accountability records, including drug dispensing and returned drug compliance and findings.
  • Contacting primary care providers to discuss and inform patient enrollment and study progress as directed, and meeting regularly with investigator and research team to discuss participant participation and protocol progress.
  • Timely notification of the investigator, sponsor, and IRB of adverse events as outlined in the protocol.
  • Scheduling sponsor monitoring visits as directed by the Director of Clinical Research Operations, preparing case report forms and collecting source documents for sponsor/audit review.
  • Meeting with research team during routine visits to discuss case report form completion, query resolution, and other protocol-related issues and preparing for and participating in FDA inspections.
  • Scheduling participants for follow-up visits and assessing participants' compliance with the test drugs on follow-up visits. Recognizing and reporting abnormal laboratory values, and collecting and documenting information for evaluation by the investigator if adverse events occur. Documenting protocol deviations and exemptions by obtaining and reviewing original source documents (e.g., recordings, scans, tests, and procedure results). Abstracting data from medical records, clinic, consultation, and referral notes to study forms and flow sheets; recording data onto case report forms; and maintaining source documentation for all case report entries.
  • Other duties may be assigned as required.

QUALIFICATIONS

  • Bachelor's degree in a scientific discipline preferred or equivalent experience.
  • 1-3+ years of clinical research experience.
  • Medical and scientific knowledge preferred.