Screening Coordinator

2 months ago

Hialeah, United States Evolution Research Group Full time
Job Details

Job Location
LOC003 CPMI Clinical Pharmacology Miami - Hialeah, FL

Description

Title: Screening Coordinator

Location: CPMI

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

Job Description:

The Screening Coordinator participates in clinical research studies conducted by Clinical Research Coordinators, assists, and performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data.

Responsibilities:

Clinical:
  • Assist in the administration of the informed consent.
  • Assist with the administration of study drug.
  • Assist in the capturing and reporting of adverse events, including serious adverse events.
  • Notify the Clinical Research Coordinator and appropriate management staff of abnormal results while collecting data, adverse events, or unusual incidents.
  • Assure minimal discomfort for study participants while performing all duties.
  • Check and ensures participants are ready for study procedures in a timely manner.
  • Check and ensure the procedure area is set up according to protocol requirements.
  • Perform duties of taking temperature, weight, height, blood pressure, and pulse
  • Perform a variety of routine blood drawing procedures to include venipuncture techniques using standard equipment to include vacutainer tubes and sleeves, tourniquets, syringes, and butterfly needles.
  • Confer with patient to obtain information for laboratory records, explain procedures, allay fears, and elicit cooperation.
  • Choose appropriate vials and containers necessary for specimen collection, depending upon tests ordered.
  • Maintain skills in the use of EKG machine and in taking accurate vital signs.
  • Assist staff and related medical staff with study participants care as requested, to include but not limited to, lifting patients, cardiopulmonary resuscitation, bandaging, and other life saving measures as directed.
  • Participate in all "study initiation" meeting for assigned studies.
  • Provide top quality care and concurrently handle high levels of stress.
  • Clinical skills indicated by level of education, licensure, registration and/or certification.
  • Perform study events and collects clinical data as directed by principal investigator and protocol.
Administrative:
  • Monitor and ensure study data is collected following plan of care, guidelines and identified group resources.
  • Participate in collaborative team efforts with other departments.
  • Check and ensure that procedure areas are properly stocked with study supplies and equipment (i.e., blood tubes, kits, study flowsheets, ECG machines, BP cuffs, etc.)
  • Assist assigned Clinical Research Coordinator review of study schedules to ensure that study procedures are properly prepared.
  • Anticipate, recognize, and resolve issues.
  • Recognize the need the seek assistance or inform senior management of specific issues.
  • Reads and understands each protocol in which they are involved.
  • Follow established guidelines in the collection of clinical data and/or administration of clinical studies.
Educational:
  • Maintain current licensure, registration and/or certification within educational background.
  • Maintain current BLS and/or ACLS certification.
  • Maintain necessary CEU's for licensure, registration and/or certification.
  • Actively participate in ongoing Quality Assurance Program, HIPAA, and Compliance Programs
  • Keep apprised of all new OSHA and GCP/ICH rules and regulations.
  • Attend all appropriate team meetings regarding study protocols.
  • Maintain skills in use of EKG machines, Holter hook-up and monitoring, diabetic monitoring and taking accurate vital signs.
  • Read and understands policy and procedures manuals, SOP manual and employee handbook.
Additional Responsibilities:
  • Comply with all policies and procedures, especially those regarding protocol confidentiality.
  • Demonstrate a caring, professional attitude and behavior toward study participants and staff, actively contributing to the well-being and dignity of the clinic.
  • Maintain an overall good work attitude, promoting cooperation and professionalism and interactions with other staff members.
  • Maintain assigned work areas in a clean, safe condition, and reports any potential hazards immediately.
  • Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.
Skills and Qualifications:
  • Education and experience
  • Professional Licensure, Registration and/or Certification in a clinical or allied health field is preferred with a minimum of one-year clinical research experience.
  • BLS and/or ACLS, phlebotomy and injections certifications preferred but not required.
  • Certified Clinical Research Coordinator (CCRC) preferred but not required.
  • Requirements
    • Bilingual skills are preferred but not required.
    • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
    • Knowledgeable in medical terminology
    • Excellent communication skills (interpersonal, written, verbal)
    • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as RealTime and other Electronic Data Entry platforms)

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