Clinical Research Coordinator

Benefits 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 Job Description 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 sponsors at the institute. The role involves performing study procedures, transcribing source data to case report forms, and liaising 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, 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). We seek team members who embrace and champion diversity; candidates should be comfortable with exposure to imagery, events, and materials that reflect our culture of acceptance and expression, ensuring alignment with our values. Responsibilities This list may not include all duties assigned. Apply knowledge of study design and flow chart to evaluate protocol feasibility at the research site and develop a strategy for implementing study procedures in compliance with the protocol. Prepare and submit documents to the institutional review board, attend and participate in investigator meetings as directed, and initiate query requests to sponsors for the study. Recruit and screen 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 and follow-up appointments. Obtain informed consent documentation from research participants prior to any study-related procedures, maintain patient screening enrollment logs, and follow randomization procedures per protocol, ensuring protection of patients' confidentiality and privacy during initial and follow-up interviews and visits. Dispense study drugs per protocol, review participants' diaries and questionnaires as appropriate, and collect, batch, and ship specimens as required. Adhere to HIPAA requirements when transmitting data via fax, mail, or electronically as requested by the sponsor or CRO, and resolve data queries and maintain files for all study-related documentation. Complete and maintain all study drug accountability records, including drug dispensing and returned drug compliance findings. Contact primary care providers to discuss and inform patient enrollment and study progress as directed, and meet regularly with investigator and research team to discuss participant participation and protocol progress. Timely notify the investigator, sponsor and IRB of adverse events as outlined in the protocol. Schedule sponsor monitoring visits as directed by the Director of Clinical Research Operations, prepare case report forms and collect source documents for sponsor/audit review. Meet with research team during routine visits to discuss case report form completion, query resolution, and other protocol-related issues, and prepare for and participate in FDA inspections. Schedule participants for follow-up visits and assess participants' compliance with test drugs on follow-up visits; recognize and report abnormal laboratory values, and if adverse events occur, collect and document information for evaluation by the investigator. Document protocol deviations and exemptions by obtaining and reviewing original source documents (e.g., recordings, scans, tests, and procedure results). 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. Qualifications 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 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: Understanding of applicable federal regulations for clinical trial participation. Strong Communication Skills: Demonstrates strong written and verbal communication 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). Professionalism, Ethics, and Integrity: Fosters teamwork, collaboration, cooperation, and flexibility; adapts to rapidly changing work environment and uses good judgment in decision‑making. Language: Ability to communicate in English (verbal and written). Bilingual in Spanish a plus. Company Requirements Must pass a pre‑employment drug test, physical, and a background check to include a 7‑year criminal, 10‑year SSN & employer history reference check. Must provide proof of COVID‑19 vaccination on the first day of work. Excellent interpersonal skills. Attention to detail. Must work flexible schedules. Must take yearly flu shots or wear flu mask during flu season for patient‑facing positions and test for tuberculosis as required by the Centers for Disease Control and Prevention. #J-18808-Ljbffr Men's Health Foundation