Clinical Research Coordinator 1

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work. 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. The Clinical Research Coordinator ensures the safety of volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities — responsible for recruiting suitable participants and coordinating studies according to protocol.

Location

100% Onsite at Accellacare, 5653 Frist Blvd., Ste. 239, Hermitage, TN 37076

Schedule

Monday – Friday, 8:00am – 5:00pm (no weekends or holidays)

Responsibilities

• Performing technical and clinical requirements of study protocols: venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holter monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ), and 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, administration, and general protocol knowledge with a focus on clinical procedures
• Obtaining knowledge about study drugs with an emphasis on injection or intravenous infusion medications
• Monitoring for possible complications with the administration of study drugs, emphasizing injections or intravenous infusions
• Maintaining accurate dispensing logs (separate from coordinator logs) including 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 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 services 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
• 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 protocol-specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including proper documentation for both
• Monitoring and maintaining refrigerators, freezer units, and investigational product storage temperatures for safety and stability
• Obtaining and maintaining knowledge regarding temperature monitoring devices and procedures for lab specimens and investigational products, and providing detailed information to all staff and sponsors on how temperatures are monitored and maintained
• Maintaining certification for packaging and shipping specimens on dry ice, and maintaining/updating knowledge of lab procedures to assist with workflow
• Acting as the OSHA Representative for the site: 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

Requirements

• 1+ years of work experience in a clinical research or pharmaceutical environment
• 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

Benefits

• 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 (LifeWorks) offering 24-hour access to a global network of over 80,000 independent specialized professionals supporting you and your family's well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others