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Pharmaceutical Clinical Associates, LLC
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Princeton ,
NJ
The role for project-related administrative support is primarily to assist the CCRM in all study-related activities as needed. All activities listed below are performed at the request of and under the direction of a CCRM. Project-related administrative support is responsible for but not limited to:
· Requesting Confidentiality Agreements for potential Investigators
· Requesting contracts (Investigator and Consultants)
· Assisting in formatting documents (e.g., clinical trial protocols)
· Tracking receipt of original CRFs
· Transmitting on-going study information
· Arranging meetings at the request to CRAs, CCRM, global CCRM or Head, CCR
· Preparing expense reports
· Maintaining calendars upon request of CCRMs
· Completing DR7 forms, requesting clinical supplies (Princeton office only)
· Completing request for clinical supplies and submitting to Milan and/or BRU
· Maintaining investigator lists
· Preparing and sending clinical trial protocol information to potential investigators
· Preparing and sending pre-study information (e.g., FDA Form 1572 , patient information/consent form, CTA templates, IB) to sites selected to participate in a clinical trial and tracking this information
· Creating and maintaining Trial Master Files stored, in-house, at Bracco
· Insuring that all study-related documents are filed promptly and accurately
· Preparing Investigator/Trial Master File Notebooks for use in trials
· Making travel arrangement for site visits and other meetings (including making requests for travel to Head, WWMA and MA Calendar)
· Acting as a liaison for site personnel while CCRM is out of the office, notifying either the CCRM on the project or another CCRM when immediate communication with the site is needed
· Assisting CCRM in planning Investigator meetings and preparing related materials required such as Investigator Binders, agendas, presentations.
· Tracking regulatory documents as they are received
· Implementing cost-saving methods when performing all tasks (e.g., FEDEX shipments)
Additionally, the Administrative Support Person should possess the following characteristics:
* Attention to Detail
* Must exhibit professionalism
* Capable of handling multiple projects
* Demonstrated organizational skills
* Strong computer skills (Word, Excel, Powerpoint, Outlook)
* Good interpersonal skills
* Must work well with others and be a good team player
It is advantageous to have experience as an administrative support person in a Clinical Research Department for at least one year.
Experience and Skills:
The role for project-related administrative support is primarily to assist the CCRM in all study-related activities as needed. All activities listed below are performed at the request of and under the direction of a CCRM. Project-related administrative support is responsible for but not limited to:
· Requesting Confidentiality Agreements for potential Investigators
· Requesting contracts (Investigator and Consultants)
· Assisting in formatting documents (e.g., clinical trial protocols)
· Tracking receipt of original CRFs
· Transmitting on-going study information
· Arranging meetings at the request to CRAs, CCRM, global CCRM or Head, CCR
· Preparing expense reports
· Maintaining calendars upon request of CCRMs
· Completing DR7 forms, requesting clinical supplies (Princeton office only)
· Completing request for clinical supplies and submitting to Milan and/or BRU
· Maintaining investigator lists
· Preparing and sending clinical trial protocol information to potential investigators
· Preparing and sending pre-study information (e.g., FDA Form 1572 , patient information/consent form, CTA templates, IB) to sites selected to participate in a clinical trial and tracking this information
· Creating and maintaining Trial Master Files stored, in-house, at Bracco
· Insuring that all study-related documents are filed promptly and accurately
· Preparing Investigator/Trial Master File Notebooks for use in trials
· Making travel arrangement for site visits and other meetings (including making requests for travel to Head, WWMA and MA Calendar)
· Acting as a liaison for site personnel while CCRM is out of the office, notifying either the CCRM on the project or another CCRM when immediate communication with the site is needed
· Assisting CCRM in planning Investigator meetings and preparing related materials required such as Investigator Binders, agendas, presentations.
· Tracking regulatory documents as they are received
· Implementing cost-saving methods when performing all tasks (e.g., FEDEX shipments)
Additionally, the Administrative Support Person should possess the following characteristics:
* Attention to Detail
* Must exhibit professionalism
* Capable of handling multiple projects
* Demonstrated organizational skills
* Strong computer skills (Word, Excel, Powerpoint, Outlook)
* Good interpersonal skills
* Must work well with others and be a good team player
It is advantageous to have experience as an administrative support person in a Clinical Research Department for at least one year.
Additional Information:
Job Level: Any
Number of Openings: 1
Years of Experience:
Level of Education: Any
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Princeton , NJ
Princeton , New Jersey
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©2008 Pharmaceutical Clinical Associates
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