ExecuPharm FSP - Clinical Trial Administrator

Job Title: ExecuPharm FSP Clinical Trial Administrator (CTA)

Position Purpose:

The Clinical Trial Administrator (CTA) administers, maintains and supports the logistical and administrative aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). The incumbent is also a point of contact and support for the clinical trial team.

Organizational Relationships:

• Reports to ExecuPharm (EP) Line Manager with day-to-day direction from the Client

• Interfaces with cross-functional study team members in a matrix environment (i.e. data management)

Primary Duties:

• Assists with the set-up, management and maintenance of electronic Trial Master Files (eTMF), in accordance with GCP.

• May be involved with set up, management and maintenance of other program/study related files and electronic filing systems.

• Supports the clinical team regarding preparation of essential clinical trial documentation, ensuring distribution, tracking and filing of documents as applicable.

• Coordinates with clinical supply staff as needed to ensure adequate availability for study needs.

• Coordinates management and maintenance of study documents including quality control checks as directed by operations trial leads.

• Coordinates archiving of study documents as directed by operations trial leads.

• May support training of new users on eTMF and SOPs.

• As directed, will arrange and participate in meetings including preparation and distribution of agendas, meeting materials and taking/distributing meeting minutes.

• Maintains up-to-date study team contact lists.

• Assists with the review, tracking and processing of payments/invoices related to investigators, consultants and service providers.

• Performs general clerical duties in support of clinical trials, e.g., copying, faxing, mailing, filing, and making travel/meeting arrangements, ordering study materials as required.

• Assists Clinical Trial Manager in site management activities as requested.

• Performs additional tasks as required to support Clinical and Technical Operations managers.

• Able to work effectively with CROs as requested

• Updates enrollment status for assigned trials and helps to develop and maintain tracking tools as requested

• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training

• Adheres to EP and Client SOPs and processesQualificationsSkills and Education:

• H.S. Diploma is required; Associate degree or higher is preferred

• Minimum of 5 years of administrative experience, including at least 2 in the pharmaceutical/biotechnology/CRO industry

• Experience supporting clinical trials is strongly preferred

• Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is strongly preferred

• Attention to detail and accuracy in work

• Effective time management and organizational skills

• Good analytical and problem-solving skills

• Strong communication skills, both oral and written

• Ability to operate standard office equipment, including but not limited to computers, printers, telephone systems, copiers and fax machines

• Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook), MS Project and Adobe Acrobat

• Prior experience of working with CROs and other providers preferred

• Willingness to travel as required for key company meetings

• Exhibits ability to ‘multi-task’ effectively

• Ability to interact well with various team members and provide value added support to project

• Displays ability to independently solve routine problems following standard policies/proceduresEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.