Clinical Research Coordinator

1-2 years

Not Disclosed

New Brunswick

10 June 17, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

WHY VITALIEF?

Vitalief is a pioneering consultancy addressing the healthcare human capital epidemic. Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions.

Reasons to Work for Vitalief:

Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
We give everyone a seat at the table – we encourage innovation.
We’re committed to our employees – you are encouraged and mentored by the talented Vitalief team to achieve full potential.
“Life/Work” balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.

Salary Range: $60,000 to $70,000 annually

Work Location: Work is 5 days per week on-site in New Brunswick, NJ.

Job Responsibilities:

Under the direct supervision of the Nurse Manager of Clinical Research Center (CRC), you will be responsible for performing a wide variety of tasks to ensure successful Oncology related clinical trials.
Manage eligibility check lists, perform patient screening/consenting (informed consent), patient activation and managing patient care (patient retention).
Assist with monitoring patient visits.
Track deviations and documenting SAEs (serious adverse events).
Ship specimens to central labs or research labs.
Track data queries and prepare data for an upcoming audit.
Work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner.

Required Skills:

Minimum of 1 to 2 years of experience in Clinical Research as a Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance and data management.
Bachelor’s Degree required.
Any experience in Oncology and/or working on complex clinical trials is a plus.
Ability to work on 12 to 15 concurrent trials – must have strong organizational and prioritization skills.
The keys to success in this role are your ability to demonstrate your versatility, “can do” attitude, and adaptability.
Considerable understanding of Good Clinical Practice (GCP) guidelines.
Experience in preparation of documents for submission to the Institutional Review Board (IRB), continuing reviews, and submission of amendments and modifications.
Experience ensuring Serious Adverse Events (SAEs) are completed and reported to the QA Manager and sponsor, if necessary, within reporting deadlines outlined in the protocol.
Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus.

PHYSICAL DEMANDS: Standing, sitting, walking, talking, hearing, and visual perception. Lifting up to 25lbs.

IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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