Position Summary

The candidate will be primarily responsible for assisting the Clinical Operations team in the execution of clinical trial deliverables in an effective and efficient manner.  The candidate will be responsible for development, maintenance, and archiving of files and records for multiple clinical trials, collaborating and ultimately driving the development of relevant standard operating procedures (SOP), managing all other files and records in support of the department, and, in some cases, will provide administrative support.

Requirements/Qualifications:

• Previous experience in the Pharmaceutical Industry or Contract Research Organization (CRO).
• Some experience collaborating/interacting with counterparts at CROs and other vendors (laboratories, drug depots, etc.).
• At least 3 years relevant experience functioning as a clinical trial assistant or documentation specialist, or equivalent.
• Trial Master File maintenance, auditing, and reconciliation experience.
• Experience as the primary responsible party for the management of a Trial Master File (TMF).
• TMF readiness experience.
• Experience with paper and electronic document management systems (eTMF, CTMS, etc.).
• Archival of paper files and, if possible, experience auditing archived files.
• Meeting agenda and minute-taking experience.
• Experience/familiarity with any data management electronic data capture systems and/or safety database systems is noteworthy.
• Experience working on international clinical trials.
• Experience interacting with institutional review boards (IRB).
• SOP development.
• Experience providing training to new employees and existing employees for new procedures.
• Calendar management experience.
• Expense report completion experience.
• An understanding of the regulatory requirements in the United States, as they pertain to essential documents and SOPs.
• Experience interacting with investigational sites.
• Minimum of Associate's Degree, Bachelor's Degree preferred.
• As is inherent to the position, the candidate must be able to perform lifting of archiving boxes, i.e., 25 lbs.

Pre-requisite Skills:

• Experience and familiarity with TMF maintenance and Essential Documents.
• Strong grasp of Good Documentation Practice and International Conference on Harmonisation Good Clinical Practice compliance, specific to the management of Essential Documents.
• Experience collaborating and interacting with internal and external partners from a variety of cultural backgrounds and geographic locations. (Although not required, familiarity with other languages will be noted.)
• Proficient with Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat.
• Excel will be used extensively. Experience with chart development and basic functions are necessary.
• Must be well-organized.
• Must have excellent verbal and written skills.
• Fluent in English.
• Some measure of flexibility will be necessary. Due to the international framework of the organization, there will be instances wherein meetings are scheduled during non-traditional workday hours.  This usually occurs no more than 2 hours prior to the standard workday. 
• The ideal candidate must be able to work independently but consistently.
• Personal interactions are critical to the role. Must have good relationship skills.

Responsibilities:

• Support the Clinical Operations team in the execution of clinical trials, initially in the US potentially expanding abroad.
• Oversee the management of the TMF for multiple US-based studies.
• Ensure proper access controls are in place for clinical trial documentation.
• Develop and maintain a system for the receipt, tracking, and archiving of clinical trial documentation.
• Provide support in start-up, maintenance, and close-out activities for investigation sites, specifically as these pertain to records management.
• Provide administrative support.
• Draft meeting agendas and meeting minutes.
• Liaise with facilities/shipping and postal vendors/IT on a routine basis.
• Establish and maintain filing system for non-TMF documentation.
• Assist and, in some cases, spearhead the develop of SOPs as they pertain to trial master file procedures.
• Maintain databases for publication material and investigative sites.
• Perform background research on potential investigators, and in some cases, prospective vendors.
• Work independently with little instruction for routine work.
• There will be minimal travel time.