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ICON Strategic Solutions · 3 days ago

Clinical Research Coordinator Level 2

US, Winston-Salem, NC 27103

Full-time

Onsite

Entry, Mid Level

1+ years exp

ICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Clinical Research Coordinator 2 to ensure the safety of volunteers, promote the mission of Accellacare, and coordinate clinical studies according to protocol.

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

Qualification

Clinical research experienceNeurology clinical trialsPharmaceutical environmentAttention to detailTime managementMotivatedLife sciences degreeOrganizational skills

Required

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

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, 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.