EMPLOYMENT AT MEDSOURCE
MedSource is committed to serving our employees and our clients - we firmly believe these are not mutually exclusive goals. We understand only by working together can a trial, and a company, be successful. Our motto, “Taking Relationships as Seriously as Science” is not an empty catchphrase, but a standard exemplified by all individuals within our organization.
Our experienced staff is the reason for our overall success. We operate individually, yet as a cohesive team, working toward a common objective.

• We're focused, flexible, committed people.
• We enjoy a work environment that's fast-paced and high-energy.
• We feel fulfilled by hard work done well.
• We're actively involved in our projects from beginning to end and, therefore, have an understanding of and appreciation for the development process as a whole.

If you are interested in employment with MedSource, please submit your CV with a brief cover letter to .

Clinical Research Associates/Regional CRAs

Description:
The clinical research associate position is home-office-based. Responsibilities include:

• Conducting site visits to determine protocol and regulatory compliance.
• Preparing required site visit and documentation reports.
• Representing MedSource within the global medical research community.
• Developing collaborative relationships with investigative sites and Sponsor company personnel.
  
  Requirements:
• Bachelor's degree in life science, nursing, a related field, or equivalent experience.
• A minimum of two years of monitoring experience.
• Knowledge of GCPs and FDA regulatory requirements and guidelines for clinical monitoring.
• Effective clinical monitoring skills, management skills, and communication skills.
• Experience conducting qualification, initiation, interim and close-out visits.
  Position involves extensive travel (about 60% of work time). Starting salary based upon education and experience.

Clinical Project Manager

Description:
The clinical project manager directs Phase I - IV clinical trials. Responsibilities include:

• Designing, communicating and implementing project plans.
• Facilitating budget and contract development.
• Tracking project activities and managing timelines.
• Managing study teams to ensure the progress of clinical trial development and implementation.
  
  Requirements:
• B.S. or higher.
• CRO or pharmaceutical company project management experience.
• Proven team management experience.
• Proven administrative management.
• Proactive problem-solving skills.
• Ability to multi-task, meet rigorous timelines and deal with stressful situations.
• Significant development process knowledge and experience, including study initiation procedures, clinical monitoring functions, drug safety and regulatory affairs issues, data flow, analysis and report generation, and FDA regulatory requirements (GCPs, CRFs, etc.)

Starting salary based upon education and experience.

Regulatory Affairs Manager

Description:
The Regulatory Affairs Manager will manage the regulatory process in document management of clinical research trials in compliance with U.S. and foreign regulatory requirements.  

• Primary contact for project specific regulatory submissions.
• Manage a Regulatory Affairs team.
• Maintain a basic working knowledge of relevant protocols.
• Establish regulatory submission processes and establish regulatory timelines.
• Collect, log, file, and/or track study documents/trial master file in the project tracking system in accordance with client/company SOPs, ICH, and federal regulations.
• Coordinate regulatory workflow; provide regulatory support, and tracking regulatory timelines.
• Participate in regulatory affairs initiatives aimed at improving internal standards and systems.
• Communicate with sites to provide information, track documentation, and overall progress of clinical trials and adherence to established guidelines.

Requirements:

• B.S. or higher.

• Minimum of 5 years experience in a CRO, biotech or pharmaceutical environment and knowledge of the clinical trials process.
• Experience with ICH/GCP documentation and process.
• Possess excellent planning skills coupled with outstanding verbal and written communication skills.
• Possess the ability to manage a Regulatory Team while handling multiple projects.
• Requires a highly motivated, resourceful, creative, decisive self-starter that can set goals, shift priorities, work independently with project teams.

Starting salary based upon education and experience.

Regulatory Affairs Specialist

Description:
The Regulatory Affair Specialist will perform a variety of administrative duties to support the regulatory function and study team in the document management of clinical research trials from the project development stage through project completion. 

• Contact for project specific regulatory submissions.
• Assistance with performing file audits.
• Assist in collecting, logging, filing, and/or tracking study documents/trial master file in the project tracking system in accordance with client/company SOPs, ICH, and federal regulations.
• Assist with coordinating regulatory workflow, providing regulatory support to the team and tracking regulatory project timelines.
• Maintain a basic working knowledge of relevant protocols.
• Provide filing, faxing, photocopying, and mailing support for designated project
  team(s) as required.
• Communicate with sites to provide information, track documentation, and overall progress of clinical trials and adherence to established guidelines.

Requirements:

• High school degree or GED required.  Bachelors’ degree (BS, BA, RN) in a science-related field preferred

• 1 year of experience working in the pharmaceutical, biotechnology, or CRO industry and knowledge of the clinical trials process.
• Possess outstanding verbal and written communication skills.
• Ability organize/reorganize workload of multiple projects in accordance with project priorities/assignments and timelines.
• Requires a highly motivated, resourceful, creative, decisive self-starter that can set goals, shift priorities, work independently with project teams.

Starting salary based upon education and experience.

Project Team Assistant

Description:
The Project Team Assistant assist in the performance of all administrative activities associated with the management of clinical trail.  

• Assist in subject tracking, regulatory document review and tracking, kick-off meeting preparation, team calendar maintenance, distribution of newsletters, periodic audits of study files and other duties as required.
• Creates tables, charts, and reports for the sponsor, and overall management of study related information such as patient enrollment and regulatory document tracking.
• Assist with coordination of packing, shipping, and tracking of supplies and materials to study sites.
• Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.
• Maintain a basic working knowledge of relevant protocols.
• Transcribes accurate meeting minutes.

Requirements:

• High school degree or GED required.  Bachelors’ degree (BS, BA, RN) in a science-related field preferred.

• 2-3 years of experience working in the pharmaceutical, biotechnology, or CRO industry and knowledge of the clinical trials process
• Possess outstanding verbal and written communication skills. 

• Good computer skills including MS Word, Excel, PowerPoint, Outlook.
• Ability to work individually and as part of a project team, meet deadlines & take instruction from multiple individuals.
• Good interpersonal and listening skills.
• Ability to multi-task, meet rigorous timelines and deal with stressful situations.

Starting salary based upon education and experience.