Clinical Research Coordinator Level 1

IREWinston-Salem, NC
2dOnsite

About The Position

CRC Level 1 - Winston Salem, NC (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We have an incredible opportunity for a Clinical Research Coordinator 1 to join ICON’s Accellacare team. The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. This role is with Accellacare , part of ICON's clinical research network, where you’ll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Location: Onsite (1901 S. Hawthorne Road, Suite 306, Winston-Salem, NC)

Requirements

  • 1+ years of work experience in a clinical research or pharmaceutical environment, with prior CRC experience
  • Experience with Neurology or Psychiatric clinical trials
  • Strong attention to detail
  • Motivated about a career in clinical research
  • Excellent time management and planning skills with an organized approach to work
  • Bachelor's degree in life sciences or other related field

Responsibilities

  • Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator.
  • Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures.
  • Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications.
  • Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions.
  • Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication.
  • Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events.
  • Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit.
  • Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts.
  • Proactively promoting the site with monitors and in-house contacts for future trials.
  • Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors.
  • Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit.
  • Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both.
  • Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability.
  • Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained.
  • Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow.
  • Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff.
  • Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records.
  • Supporting training and additional development of clinical skills for site staff as needed

Benefits

  • In addition to your competitive salary, ICON offers a range of additional benefits.
  • Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
  • Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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