Discover a career with greater purpose

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.

• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

• Assist with periodic review of study files for completeness.

• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.

• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. 

• With moderate oversight and supervision, serve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the  Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.

• Prepare site documents, reviewing for completeness and accuracy.
  Inform team members of completion of regulatory contractual. and other documents for individual sites. 

• Distribute completed documents to sites and internal project team members.

• Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.

• Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
  

Job Requirements:

• Bachelors Degree in Pharmaceutical or related field

• Min. 1 - 3 years of experience in clinical research environment

• Open to candidates from non-clinical research environment but strong experience in administrative duties

• Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

• Broad knowledge of applicable protocol requirements as provided in company training

• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint

• Good written and verbal communication skills including good command of English language

• Effective time management and organizational skills

• Ability to establish and maintain effective working relationships with coworkers, managers and clients