Men’s Health Foundation connects men at risk to comprehensive healthcare and wellness through education, collaboration and advocacy, inspiring and empowering all men to live longer, healthier and happier lives. We see a world where inequity and stigma do not separate men from healthcare. At Men’s Health Foundation we are reimagining men’s healthcare.
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 of 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.
- Schedule participants for follow-up visits and assess participants' compliance with the test drugs on follow-up visits. You must be able to recognize and report abnormal laboratory values, and, if adverse events occur, you must collect and document this information for evaluation by the investigator. In addition, you will document protocol deviations and exemptions by obtaining and reviewing original source documents (e.g. recordings, scans, tests, and procedure results). As a Clinical Research Coordinator, you will abstract data from medical records, clinic, consultation, and referral notes to study forms and flow sheets; record data onto case report forms; and maintain source documentation for all case report entries.
- Other duties may be assigned, as required.
- Bachelor's degree in a scientific discipline preferred or equivalent experience.
- CCRP certification preferred.
- 2+ years of clinical research experience.
- Medical and scientific knowledge preferred.
SKILLS AND COMPETENCIES:
- Patient Care: Demonstrated ability to work effectively with a diverse population, including individuals who of differing races, ethnicities, sexual orientations, gender identities, socio-economic backgrounds, religions, ages, English-speaking abilities, immigration statuses, and physical abilities.
- Knowledge of FDA Regulations and GCP Guidelines: an understanding of applicable federal regulations for clinical trial participation.
- Strong Communication Skills: Demonstrates strong written and verbal communications skills. Ability to establish and maintain positive relationships with study participants and team members
- Computer Skills: Working knowledge of MS Office Suite, electronic Health Records (EHR), Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC).
- Maintains Professionalism, Ethics, and Integrity in all actions: Fosters teamwork, collaboration, cooperation, and flexibility in all aspects of the role. Adaptability to a rapidly changing work environment. Ability to use good judgment in decision-making.
- Language: Ability to communicate in English (verbal and written). Bilingual in Spanish a plus.
- Must be able to pass a pre-employment drug test and a background check to include a 7-year criminal, 10-year SSN & employer history reference check
- Excellent interpersonal skills
- Attention to detail
- Must be able to work flexible schedules
- Must take yearly flu shot or wear mask during flu season and test for tuberculosis as required by the Centers for Disease Control and Prevention.
Men's Health Foundation