Clinical Trial Specialist

Actalent•Newark, NJ

48d•$35 - $38•Hybrid

About The Position

As a Clinical Trial Specialist, you will coordinate the initiation and activation of new clinical trial protocols. This role involves verifying necessary approvals from various boards and committees, preparing study tools, and ensuring that all patient documentation is accurate and complete. You will work closely with Research Nurse Clinicians and physicians to confirm protocol eligibility and maintain comprehensive research records.

Requirements

Clinical Research Coordination
Experience in Oncology
Informed Consent Processes
Patient Recruitment and Enrollment
Experience with Source Documents
2-3 years of clinical research coordinator experience

Nice To Haves

Bachelor's Degree
Solid knowledge of computer software programs such as Excel, Word, and Access
Detail-oriented with excellent organizational, communication, and interpersonal skills
Ability to maximize resources and seek personal and professional responsibility

Responsibilities

Coordinate the initiation and activation of all new clinical trial protocols, ensuring all necessary approvals are obtained before study activation.
Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.
Develop study tools using software like Excel and Word, and review patients' charts to confirm protocol eligibility.
Ensure informed consent forms are obtained, signed, and properly filed in the medical records.
Register consented research patients with the study sponsor and input data into the clinical trials database.
Maintain research records, including patient consent, eligibility, Case Report Forms (CRFs), registration confirmation, and corresponding source documents.
Assist with grading adverse events using National Cancer Institute criteria or protocol-specific grading scales.
Complete Serious/Unexpected Adverse Event (SAE) forms as required by study sponsors, federal requirements, and institutional guidelines.
Provide regular reports to tumor study group members and the Principal Investigator on assigned studies.
Serve as a study liaison with study sponsors, scheduling monitoring visits and conference calls, and responding to sponsors' queries.