Assistant Clinical Research Coordinator at Evolution… · CPMI-Clin…

About Company:

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S.and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

Job Description:

ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS. With 18 wholly owned clinical sites, we conduct in-patient and out-patient phase I-IV clinical research studies. Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible.

The Assistant Coordinator participates in clinical research studies conducted by the Clinical Research Coordinator. They assist and perform a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data.

Responsibilities:

Administrative:

• Monitor and ensure study data is collected following plan of care, guidelines and identified group resources
• Serve in rotation with assistant clinical coordinators and clinical research coordinators
• Serve as liaison between assigned clinical research coordinator and all clinical departments
• Participate in collaborative team efforts with other departments
• Discuss and administer Informed Consent Form
• 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 study schedules to ensure that study procedures are properly staffed
• Assist assigned Clinical Research Coordinator with the creation and/or review of study flowsheets to ensure study is conducted according to protocol requirements
• Anticipate, recognize, and resolve issues
• Reads and understands each protocol in which she/he is involve
• Follow established guidelines in the collection of clinical data and/or administration of clinical studies
• Performs all other duties as assigned

Clinical Responsibilities

• Support adverse event reporting and informed consent administration
• Notify staff of abnormal results or incidents
• Ensure participant comfort and readiness for procedures
• Set up supplies and procedure areas per protocol
• Perform venipuncture, vital signs, ECG, and other assessments
• Communicate with participants to explain procedures and gather data
• Assist with patient care and emergency measures as needed
• Attend study initiation meetings and perform study-related tasks
• Provide high-quality care under pressure

Educational:

• Maintains current licensure, registration and/or certification within educational background
• Maintains current BLS and/or ACLS certification
• Maintains necessary CEU’s for licensure, registration and/or certification
• Actively participates on CPMI’s ongoing Quality Assurance Program, HIPAA and Compliance Programs
• Keeps apprised of all new OSHA and GCP/ICH rules and regulations
• Attends all appropriate team meetings regarding study protocols
• Maintains skills in use of EKG machines, Holter hook-up and monitoring, diabetic monitoring and taking accurate vital signs
• Reads and understands CPMI policy and procedures manuals, SOP manual and employee handbook