Clinical Specialist

Ockham Raleigh , NC 27611

Posted 2 months ago

Job Overview:

We are seeking a Clinical Specialist for our GSS group to review and codify client informed consent documents into GSS GloblaCODE system. Also interprets client protocol documents to build the Specimen Test Plan in the GSS GloblaCODE system.

Will be responsible for retrieval, review, codification of client informed consent documents. QC peer completed codification. Attend client meetings as codification representative. Works with client on client specific standards. Other duties will include the following:

  • Codification of Informed Consents based on company SOP's

  • Entry of codification information into spreadsheet or online system

  • Peer review QC of codification

  • Collecting client informed consent documents from multiple systems

  • Tracking ICF documents received and codified for billing

  • Create, update, track client specific codification guidelines

  • Attend client meetings to discuss GSS codification processes and client specific codification process

  • Organize timelines for codification of client studies

  • Organize and re-prioritize ICF resources as needed

  • Train new ICF Codification employees

  • Development and entry into GlobalCODE of Specimen Test Plans (STP)

  • Quality Control of Specimen Test Plans

  • Update of STP based on client documentation

  • Assist with development and maintenance of documentation

  • Assist Quality Assurance in regulatory certifications (ISO, Data Privacy, etc), validation processes, SOP


  • Any corporate activities assigned


Education Minimum Requirement: Bachelor's Degree

Required Experience and

  • At least 3 years of experience working in clinical trials, laboratory, or specimen management


Desired Experience and

  • A Bachelor's degree, preferably in science or a related field

  • Knowledge of clinical specimen operations and/or informed consent documents

  • Knowledge of specimen management, clinical pharmacogenomics, or biomarker research

  • Proficient basic computer skills including Word, Excel, PowerPoint, email management

  • Ability to learn basic software applications

  • Proven ability to plan, prioritize, and manage in a fast-paced environment with a high degree of initiative

  • Strong drive for process optimization and data integrity

  • Excellent communication and interpersonal skills with great attention to detail

  • Experience writing, reviewing, or reading protocol or lab documentation, or informed consents for clinical trials

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Research Coordinator I Clinical Research Raleigh Campus


Posted 4 days ago

VIEW JOBS 5/29/2020 12:00:00 AM 2020-08-27T00:00 About WakeMed: Serving the community since 1961, WakeMed Health & Hospitals is a nationally recognized, private, not-for-profit health care organization founded and based in Raleigh, N.C. The largest health system in Wake County, WakeMed exists to improve the health and well-being of our community by providing outstanding, compassionate, patient- and family-centered care to all. The 919-bed system comprises a network of facilities throughout the Triangle area, delivering health and wellness services that bring added value to the communities we serve. WakeMed is a leader in cardiac and vascular care, women's and children's services, emergency medicine and trauma care, physical rehabilitation, orthopaedics and neurosciences. Specialty facilities include the WakeMed Heart Center, Children's Hospital, Women's Pavilion and Birthplace, Rehabilitation Hospital, Adult and Children's Emergency Departments and a Level 1 Trauma Center. WakeMed's team of more than 9,400 employees, 2,000 volunteers, 1,300 affiliated physicians, and the more than 300 physicians employed by WakeMed Physician Practices use the most advanced technologies along with the best minds and the biggest hearts to ensure the finest quality in health care and community health. For more information, visit As an Equal Opportunity Employer, WakeMed provides an inclusive work environment that promotes the valuing of differences, respect for people and cooperativeness among our diverse workforce. WakeMed does not discriminate against any employee or applicant in any terms or conditions of employment. All applicants/employees are considered for employment, transfer, promotion or training without regard to race, religion, color, gender, gender identity/expression, genetics, sexual orientation, age, pregnancy, national origin, disability or veteran status. Position Information: The Research Coordinator I will assist the Investigators and research team with the planning and implementation of clinical trials. This includes, but is not limited to subject recruitment, consent, research procedures (as appropriate), CRF completion, communication and meeting with sponsor representatives, scheduling and assisting with clinical trial monitoring activities, completing research billing reviews, completing IRB submissions and reporting of adverse events and protocol deviations. Experience Requirements: 1 Year Clinical - Research Preferred - And 6 Months Clinical - Phlebotomist Preferred - And Clinical - Research Or Related Certification Preferred Education Required: High School Diploma or Equivalent Required - And College Courses Preferred Licensure/Certification Requirements: Nurse Aide I Or Emergency Medical Technician - Basic or Higher Or Licensed Practical Nurse Preferred Hours of Work: Weekdays, Day shift Weekend Requirements: As Needed Call Requirements: As needed Wakemed Raleigh NC

Clinical Specialist