Actalent Clinical Trial Associate in Florham Park, New Jersey
IMMEDIATE OPENING! Clinical Trial Associate opening for rapidly growing pharmaceutical client in Northern, NJ!!
**Client is actively interviewing with times for next week!
The purpose of this position is to provide support for the planning, execution, and financial aspects of Phase I – IV clinical studies and other tasks completed to ensure the objectives of the studies are met.
Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
Assist the Clinical Trial Managers with achieving key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, study execution, data collection, and close-out.
Assist in the preparation of study documents including, but not limited to, clinical protocols and amendments, case report forms and source document templates, informed consent forms, site training materials, site regulatory binder, site pharmacy binder, and clinical study reports.
Assist in the day-to-day operational activities and other specific projects as assigned within Clinical Operations.
Accountable for the maintenance of the electronic Trial Master Files (TMF) in accordance with SOPs
Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines.
Accountable to develop and review regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits
Act as primary liaison for study sites and monitors to convey project information and answer questions in accordance with the CTM escalation pathway
Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of clinical trial documentation.
Attends Investigator Meetings and study-specific training for assigned trials
Collaborates with the monitors to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics.
Responsible for communicating issues in accordance with the CTM escalation pathway to the monitors as appropriate.
Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for patient safety and regulatory compliance for all assigned sites.
Ensures all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned monitor
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s degree from an accredited college or university.
3 years of closely related health sciences experience; pharmaceutical industry experience is preferred; experience in the areas of clinical operations and/or project management a plus.
Demonstrated knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with medical terminology is necessary
Proven ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment.
Proficiency using Microsoft Outlook, Word, Excel and PowerPoint.
Excellent oral and written English communication skills.
Experience in various electronic data capture systems involving site enrollment and tracking is a plus.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.