Job Description

POSITION SUMMARY:

The Clinical Trial Assistant (CTA) will provide essential support to the clinical study team in planning, execution, and completion of clinical trials. This role is ideal for someone who is detail-oriented, thrives in a fast-paced environment, and is eager to contribute to advancing new therapies.

The CTA supports the in-house activities of the clinical project team to ensure timely start-up and smooth maintenance of operational and regulatory requirements of clinical studies from study initiation through study closeout.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to

• Assist with the set-up, maintenance, and tracking of clinical trial documentation, including the Trial Master File (TMF).
• Support clinical study teams in preparing study materials such as investigator site files, general forms, and IRB support.
• Coordinate logistics for study meetings and other study related activities.
• Manage study trackers, databases, and internal systems to ensure accurate and current study information is maintained.
• Communicate with study sites, vendors, and internal stakeholders to ensure timely collection and review of essential documents.
• Ensure compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements
• Provide administrative support related to the trial.
• Draft meeting agendas and assist in preparing meeting minutes.
• Accurately update and maintain clinical systems within project timelines.
• Prepare, handle, distribute, file, and archive clinical documentation and reports.
• Review of study files periodically for accuracy and completeness.

EDUCATIONAL REQUIREMENTS (degree, license, certification):

Bachelor's degree in a scientific discipline or equivalent experience in relevant positions

YEARS OF EXPERIENCE:

Prefer 6+ months of experience in the pharmaceutical or CRO industry, but willing to consider applicants coming directly from an educational background that would make them suited for entry level Biotech/research work.

PHYSICAL REQUIREMENTS / WORKING CONDITIONS OF POSITION:

N/A

OTHER SKILLS AND ABILITIES:

• Excellent organizational, communication, interpersonal skills and able to work independently and also within a team
• Effective time management and organizational skills
• Attention to detail and accuracy in work
• Ability to establish and maintain effective working relationships with coworkers, managers
• Strong computer skills including proficiency in use of Microsoft Word ,Excel and Outlook
• Experience working with Clinical Trial Management Software (CTMS) or electronic TMFs, such as SimpleTrials, a plus
• Ability to manage multiple priorities simultaneously
• Flexibility to work in a fast-paced and dynamic work environment
• Results and process-driven orientation
• Excellent verbal and written skills

Candidates must reside in the state of New Jersey.

Soligenix, Inc. offers a competitive compensation and benefits package. Compensation will be commensurate with experience. Soligenix, Inc. is an Equal Opportunity Employer.

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