Project Management Assistant

Position Overview:

This position is responsible for providing administrative support to the Pharmatech Project Management Team.  The incumbent will provide support for project administrative tasks, mass mailings, document management, subject recruitment campaigns, travel arrangement, meeting coordination and special projects.  This position is also responsible for preparing accurate, timely regulatory submissions of core project documents for clinical research studies and for monitoring and submitting changes of any core project documents to the appropriate persons, the Institutional Review Boards (IRBs) and the pharmaceutical sponsor companies or CROs.  This position participates in Team Meetings and attends all-staff meetings.

Responsibilities:                                         

1. Provide administrative support as required, including but not limited to:
   1. Word processing and spreadsheet support including correspondence preparation
   2. Telephone support to assist Project Managers
   3. Fax correspondence
   4. Schedule appointments and meetings
   5. Meeting coordination
   6. Prepare meeting agendas; take, prepare and distribute minutes
   7. Arrange travel and complete expense reports
   8. Retrieve and send email
   9. Arrange for conference calls involving more than three parties
   10. Prepare meeting materials and presentations including MS PowerPoint
   11. Document management including photocopying, disbursement and filing
   12. Perform data entry to MS Access databases
   13. Create and assemble Site Binders and Project File Binders
   14. Assist with bulk mail/email/fax projects
   15. Assist with development of source documents and enrollment tools
   16. Assist with preparation of reports for Grant Management
   17. Assist with resolution of Data Queries and Data Management reports
   18. Filing and other tasks as directed

2. Provide Regulatory document preparation, submissions, updates as required:
   1. Interact with Clinical Site to ensure Pharmatech receives all necessary regulatory documentation for IRB submittal, including but not limited to:  1572, financial disclosures,  contracts, CV’s, medical licenses, lab certifications and values, and any updates to these documents
   2. Prepare necessary regulatory documents based on investigational requirements and submit to the IRB and Sponsor/CRO as necessary
   3. Initiate any required action following IRB review, if any stipulations are noted with the protocol or informed consent
   4. Follow IRB approval with timely preparation of Regulatory Binders
   5. Ensure changes to regulatory documents are submitted to the IRB in a timely manner
   6. Submit documents to FDA as needed, and ensure any necessary follow-up
   7. Submit study and site project documents to Sponsor/CRO (when required)
   8. Interact with FDA and/or IRB as needed to achieve project regulatory goals and objectives
   9. Responsible for creation and final filing of Regulatory Binders housed in Central Files
   10. Maintain up-to-date and accurate regulatory records for each project
   11. Administer project close-out process
   12. Prepare correspondence and assist in resolving questions/problems as needed, and as requested by Pharmatech management

Position Qualifications:

An associate’s degree, preferably in a medically related field of study and 3+ years project/administrative support experience is a minimum. Clinical Research experience is preferred. The incumbent must be able to work with limited supervision and develop processes to produce results. As such, a project management assistant must be able to coordinate and track multiple activities and meet precise deadlines, while demonstrating attention to detail, time management and organizational skills. S/he must have clear written and verbal communication skills and excellent interpersonal skills. Computer proficiency in MS Word, MS Excel, MS Access, MS PowerPoint, MS Outlook and familiarity with standard office equipment is necessary.

Preferred qualifications include experience in clinical trials research and/or project management support with an understanding of GCP & ICH guidelines, regulatory/CFR and IRB requirements. Knowledge of protocol design, research methodology and medical terminology desired.

Project Manager

Position Overview:

This position is responsible for managing and successfully completing clinical research projects. The Project Manager becomes involved during the business development or proposal development of client marketing, and develops the project budget and the Project Plan. The Project Manager may also participate in protocol development and study-specific systems design. The Project Manager establishes and monitors all project activities for adherence to plan and budget and becomes the primary contact with the client for that project. The Project Manager is responsible for meeting the client's goals and timelines within budget and with high quality. Changes to the scope of a project must be reviewed and approved by the VP of Operation s prior to any commitment to the client.

Responsibilities:

1. Participate as a member of the project proposal team to assist in preparing project budgets and proposals.
2. Develop and maintain on the Pharmatech computer network and available to both internal and external authorized users a detailed Project Plan to meet the objectives of the project: contract requirements, client expectations, quality, enrollment goals, costs, time and profit.
3. As required, collaborate with clients and investigators to develop protocols, data collection methods, study binders and investigative site materials, drug distribution and accounting methods, and patient safety reporting systems.
4. Manage the project to achieve the deliverables of the project contract and the Project Plan, as follows:
   1. Act as the primary contact for the client and investigators to provide effective communication among all parties involved in the project and with Pharmatech senior management.
   2. Submit for approval all project purchases and expenses.
   3. Collaborate with clients and investigative sites in development of patient recruitment plan; monitor investigative sites and ensure enrollment quotas and timelines.
   4. Ensure monitor and/or study coordinator performance and data quality.
   5. Ensure the efficient and timely transfer and storage of all data documents.
   6. Ensure competent project files management.
5. Coordinate regular telephone and/or face-to-face meetings with the project team and with the client team to discus s project status, problems, teamwork, or new plans.
6. Address and resolve project questions and problems as needed; alert the VP of Operations of any problems that could impact the success of the project.
7. Ensure that the project is completed within compliance of all regulatory bodies, client and Pharmatech SOPs, and the project contract requirements.
8. Provide project status reports as requested by the client and Pharmatech senior management.
9. Participate in conducting periodic performance reviews of project team members and post-project evaluations, and provide related reports.
10. Act as a marketing agent in conjunction with the Pharmatech Business Development Team for future research projects with the customer.
11. Participate in investigator network development, in cooperation with clients and the Pharmatech Business Development Team.
12. As requested, provide Project Payables and Receivable s projections to Accounting.
13. Perform such other tasks as requested by Pharmatech senior management.

Position Qualifications:

A bachelor's degree, preferably in a medically related field of study and project management experience is a minimum. Project Management of pharmaceutical clinical research in a related therapeutic area i s preferred. The incumbent must be able to work in and manage a team environment. As such, a Project Manager must demonstrate leadership, the ability to listen to and develop personnel, resolve routine project problems, and have an understanding of standard business practices. Clear written and verbal communication skills and the ability to draft business correspondence and develop budgets and detailed, computerized project plans are mandatory. S/he must be able to coordinate and track multiple activities, meet precise deadlines with specific budgets, and identify and communicate to his/her supervisor problem areas before they negatively impact project outcomes. A high degree of computer literacy is required. Familiarity with MS Word, MS Excel, MS Access and basic email will be necessary. Experience with MS Project a plus.

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