Clinical Monitoring Associate



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Outstanding opportunity for recent life sciences graduates at PAREXEL International. We are looking for qualified candidates interested in becoming Clinical Monitoring Associates. The program is an investment in the learning journey of our junior talent to prepare you for a rewarding and challenging career experience with PAREXEL. The training you receive should prepare and position you as well-rounded and skilled employee in Clinical Trial Monitoring.

We are seeking candidates who have the ability to learn quickly, communicate effectively and see the big picture. If you are organized, have strong attention to detail, are able to build lasting relationships with internal and external clients, and demonstrate excellent communication skills - we want you to be a new member of the PAREXEL team. As a Clinical Monitoring Associate at PAREXEL, you will have the opportunity to directly contribute to the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease. Specifically, you perform the critical role of working directly with the sites including Principal Investigators and Study Coordinators to ensure the sites are running the trial in a manner consistent with the protocol. In addition you will act as an escalation point for sites as issues arise and ensure that reporting of data and patient information is received is both accurate and timely. Also ensure regulatory compliance through the study.

Candidates must have: A Bachelor's Degree in Life Sciences
Ability to successfully work in a team environment and display Client focused approach to work
Solid interpersonal, verbal and written communication skills
Sense of urgency in completing assigned tasks
Meticulous attention to detail
Effective time management in order to meet daily metrics or team objectives
Show commitment to and performs consistently high quality work

Specific Responsibilities include:
Build relationships with investigators and site staff and work with them to: Review recruitment plan and enrollment updates; address/resolve issues pending from the previous visit; address protocol questions; check on site staff assignment; assess drug/study supply status; request outstanding documents; review site payment status; follow-up on data entry, query status and SAEs; Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS, ISIS); Conduct remote visits (initiation, monitoring, termination)
Responsible for study and regulatory documentation including: Collect updated/amended regulatory documents in collaboration with CRA as needed; Create and distribute study documents (e.g. eSignature Agreement, Amendments, etc.); Responsible for the completeness and quality of the in-house site specific files; Update all relevant tracking system on an ongoing basis
Initial and ongoing drug / supply management
Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOP and study specific procedures (e.g. Monitoring Plan)
Additional Information
Location | | | Billerica Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013

Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided


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