Clinical Research Specialist I – Oncology & Clinical Research
About The Position
This position is 100% onsite during the training period. After successful completion of training and demonstrated proficiency, there may be the opportunity for a limited hybrid work schedule based on business needs and performance. Candidates should be prepared to work onsite full-time initially. Make an Impact on Groundbreaking Cancer Research: Are you passionate about advancing clinical research that directly impacts patient care? We are seeking a highly organized, detail-oriented Clinical Research Specialist I to support innovative oncology research initiatives and clinical trials. In this role, you will provide critical research infrastructure support while partnering with investigators, research teams, and laboratory personnel to ensure high-quality study execution, regulatory compliance, and exceptional data integrity. This is an excellent opportunity for an experienced clinical research professional who thrives in a fast-paced environment, enjoys managing multiple priorities, and is committed to advancing translational and clinical research.
Requirements
- Bachelor's degree in a scientific, healthcare, or related discipline.
- Minimum of three (3) years of clinical research experience within an academic medical center, hospital, research institution, biotechnology, pharmaceutical, or related clinical research environment.
- At least 3 years of clinical research experience, including coordinating clinical research studies and supporting research operations.
- Experience working with biological specimens (collection, processing, storage, or shipment).
- Familiarity with Good Clinical Practice (GCP) and clinical research regulations.
- Strong organizational skills with the ability to manage multiple priorities.
- Exceptional attention to detail.
- Experience with research databases and electronic data management systems.
- Ability to communicate and collaborate effectively across multidisciplinary teams.
Nice To Haves
- Experience in oncology research, biobanking, or molecular research initiatives.
- Exposure to protocol development, investigator-initiated studies, laboratory operations supporting clinical trials, reporting, database management, or process improvement and automation initiatives.
- Clinical Research Associate (ACRP/SoCRA or equivalent) certification.
Responsibilities
- Participate in the design, implementation, and coordination of clinical research projects.
- Support investigator-initiated research, including protocol development, case report forms, study documentation, budgets, and research committee coordination.
- Coordinate research activities across departments while communicating project status and improvement opportunities to leadership.
- Support research quality management initiatives and clinical trial recruitment efforts.
- Screen patients for protocol eligibility.
- Coordinate participant blood collection activities according to study protocols.
- Prepare Research Lab Kits (RLKs) and monitor participant visits.
- Create participant cohorts and generate customized reports for investigators.
- Develop and maintain oncology-focused research databases.
- Maintain study forms, Standard Operating Procedures (SOPs), and research documentation.
- Prepare research kits for multiple clinical protocols.
- Process, prepare, store, distribute, and ship biological specimens according to protocol requirements.
- Support pharmacokinetic (PK) collections, including occasional late-day or weekend sample processing as required by study timelines.
- Ensure accurate tracking and reconciliation of biological samples across multiple databases.
- Perform quality control (QC) reviews of patient and sample data.
- Enter and reconcile research information across multiple systems.
- Identify opportunities to improve workflows, automate manual processes, and reduce data entry errors.
- Ensure compliance with FDA regulations, IRB requirements, HIPAA, Good Clinical Practice (GCP), and all institutional research policies.
- Participate in required training and continuing education.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
