Lab Coordinator / Phlebotomist

Alcanza Clinical Research; North Charleston (SC); On-site; USD 38,000 - 56,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

HSA

Supplemental insurances

401k with match

Job summary

Alcanza Clinical Research Coastal Carolina Research Center in Charleston, SC, seeks a Lab Coordinator to ensure execution of lab procedures in compliance with GCP, ICH, FDA/HIPAA, and SOPs. You will draw and process specimens, assist with shipments, monitor inventory, and support start-up activities across trials.

The role requires a high school diploma or equivalent with at least 1 year of lab processing experience; an associates degree is preferred.

Qualifications

• High School diploma or equivalent and at least 1 year of lab processing experience.
• Associates degree is preferred.
• Bilingual English/Spanish is a plus.

Responsibilities

• Draw and process specimens according to each trial’s requirements
• Assist with specimen shipments to central labs and ensure proper shipping methods have been observed
• Monitor expiration dates on lab equipment and supplies
• Unpack and put away incoming lab supply shipments
• Monitor and maintain lab inventory and ensure study-specific supplies are ready for new study start-up
• Transport samples
• Provide mentoring to new hires and allow them to shadow you
• Complete and renew CITI GCP and IATA training as required
• Attend SIVs when needed, and complete sponsor-required lab training
• May support other clinical research-related activities such as recruitment, EDC and QA/Chart review as needed
• Ensuring compliance with company SOPs, FDA/HIPAA regulations, ICF documentation, and GCP guidelines
• Maintaining confidentiality of patients, customers, and company information
• Performing other related activities as assigned

Skills

Microsoft Office

EHR systems

Data entry

Organizational skills

Written and verbal communication

Interpersonal skills

HIPAA compliance

Bilingual English/Spanish

Independent work

Education

High school diploma or equivalent

Associates degree preferred

Tools

LIMS (Laboratory Information Management System)

Job description

Department

Operations

Location

Coastal Carolina Research Center | Charleston, SC

Description

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.

Lab Coordinator

The Lab Coordinator works to ensure the execution of assigned lab procedures in compliance with GCP, ICH, FED and HIPAA regulations, company SOPs, and policies.

Key Responsibilities

Essential Job Duties

Responsibilities may include but are not limited to:

• Draw and process specimens according to each trial’s requirements
• Assist with specimen shipments to central labs and ensure proper shipping methods have been observed
• Monitor expiration dates on lab equipment and supplies
• Unpack and put away incoming lab supply shipments
• Monitor and maintain both general and study-specific lab inventory, and ensure study-specific lab supplies are ready for new study start-up
• Transport samples
• Provide mentoring to new hires and allow them to shadow you as they learn.
• Complete and renew CITI GCP and IATA training as required.
• Attend SIVs when needed, and complete all sponsor-required lab training.
• May support other clinical research-related activities such as recruitment, EDC and QA/Chart review as needed.
• Ensuring compliance with company SOPs, FDA/HIPAA regulations, ICF documentation, and GCP guidelines
• Maintaining confidentiality of patients, customers, and company information, and
• Performing other related activities as assigned.

Skills, Knowledge And Expertise

Minimum Qualifications

High School diploma or equivalent and a minimum of 1 year of clinical laboratory processing experience is required. Associates degree is preferred. Bilingual (English/Spanish) skills are a plus.

Required Skills

• Proficiency with computer applications such as Microsoft applications, email, electronic health records, and web applications, and the ability to type proficiently (40+ wpm).
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
• Must be professional, respectful of others, self-motivated, and have a strong work ethic.
• Must possess a high degree of integrity and dependability.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

Benefits

• Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.