Research Assistant

Vitalief

Newark, New Jersey, United States

Newark, New Jersey, United States

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ABOUT VITALIEF
Vitalief is a consulting and professional services firm that partners with clinical research sites, sponsors, and CROs to enhance trial activation, operational performance, and workforce readiness. Our approach combines deep clinical research expertise with operational excellence and business acumen, enabling organizations to work more efficiently. We help clients streamline processes, reduce costs, accelerate timelines, and ultimately improve patient outcomes.
THE ROLE
We are seeking an experienced Research Assistant to join our team as a full-time Vitalief employee. The Research Assistant provides operational and administrative support for interventional oncology clinical research studies conducted at a leading academic research center in Newark, NJ. This role serves as a foundational position within the clinical research career pathway.
WHY VITALIEF?

Contribute to advancing scientific discoveries that improve patient lives.

PEOPLE FIRST culture with opportunities for growth and innovation.

Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans.

Work schedule: 5 days per week on-site (Newark, NJ).

Market-competitive salary, $50,000 to $55,000 (commensurate with experience).

RESPONSIBILITIES:

Under the direction of the Clinical Research Coordinator, support the planning, initiation, and execution of multiple Phase II–III oncology interventional trials, primarily involving investigational drugs and biologics, with potential radiation and surgical components.

Collaborate with principal investigators, clinical care teams, and ancillary departments (e.g., pathology, radiology, laboratory, surgery, and infusion services) to ensure protocol adherence, participant safety, and compliance with Good Clinical Practice (GCP) and institutional requirements.

Provide operational support across the full study lifecycle, including start-up, active conduct, and close-out activities.

Assist with preparation, submission, and maintenance of IRB and regulatory documentation, including amendments, continuing reviews, reportable events, and audit-ready regulatory binders.

Support participant scheduling, visit preparation, specimen collection and processing, and coordination with clinical and ancillary services in accordance with protocol and biosafety requirements.

Prepare and maintain study materials, source documentation, and participant-facing packets, track study supplies and investigational product accountability documentation as applicable.

Enter, maintain, and reconcile study data in EDC, CTMS, and institutional systems (e.g., OnCore, Epic, ) in a timely and accurate manner.

Support monitoring visits, audits, and inspections by organizing documentation and responding to sponsor, monitor, and regulatory requests.

REQUIRED SKILLS:

Bachelor's degree in health sciences, life sciences, public health, or related field, or equivalent combination of education and experience.

Minimum of one (1) year of research experience, which may include academic research, laboratory research, public health research, quality improvement projects, or research internship experience; prior clinical research experience is not required.

Demonstrated understanding of basic research principles, including data collection, documentation, and adherence to research protocols.

Strong organizational skills with the ability to manage multiple tasks, prioritize responsibilities, and meet deadlines in a fast-paced academic medical center environment.

High attention to detail and accuracy when handling data, study documentation, and regulatory materials.

Effective written and verbal communication skills, with the ability to interact professionally with investigators, research staff, clinical teams, and study participants.

Proficiency with standard office software and databases (e.g., Microsoft Office.), with the ability to learn research-specific systems such as EDC, CTMS, and electronic health records.

Ability to follow established procedures, institutional policies, and regulatory requirements, including confidentiality and data privacy standards.

Demonstrated ability to work independently as well as collaboratively within multidisciplinary research teams.

Commitment to ethical conduct of research and willingness to complete required institutional and regulatory training (e.g., human subjects protection, GCP).

PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

Newark, New Jersey, United States

Sprachkenntnisse

English

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