US Citizens only .
Has worked for a CRO
Has experience on the resume in at least two of the following: eCTD (Very Imp), ICD9 or ICD10, MeSH, MedDRA, SDTM or HL7
Link for eCTD is http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm
Has a thorough understanding of submissions to the FDA (FDA form FDA 356h)
Has been involved in the data management aspects of clinical trials (reading and interpreting clinical protocols, etc.) [NEED 2 YEARS MINIMUM EXPERIENCE]

Please send resumes to vivek@genesysi.net

Function:   Pharmacy

Travel:   No

Job Description:   Summary:The purpose of this position is to prepare pharmaceutical prescriptions in an accurate and timely manner, and to provide the related, distributive and clinical pharmacy activities to provide services to home infusion therapy patients.Job Details: Assists the physician and other healthcare professionals involved in planning and implementing patient care in the home to ensure safe and effective drug therapy Assists the physician and nursing staff in setting therapeutic objectives for drug therapy by collecting, evaluating and interpreting the results of laboratory data, clinical data and other pertinent patient information. Provides consultation and answers inquiries from patients, families, physicians and other healthcare professionals regarding drugs and their use. 8-16 hour work week (Monday- Friday)

Project Description:  Project involves conducting database analyses for the Outcomes Research team using large administrative healthcare claims data. It does not involve working with clinical trials data. The main requirements are very STRONG SAS and large Claims Database experience.
 
Required Skills:
·   4+ years SAS experience of which 1-2 years should be with large, healthcare claims database
·   Experience with health care claims data; large database experience
·   Can independently conduct retrospective database analysis with limited supervision
·   Some UNIX experience
·   Knowledge of health outcomes, health services research and/or pharmacoepidemiology
·   Good communication skills; ability to communicate statistical findings in meetings
·   Statistical background or knowledge of statistical methods such as logistic regression, survival analysis, propensity score models
 
Useful Skills:
·   Familiarity with ICD-9 and CPT Coding Systems
·   Knowledge of US Health Care System
 
This 6+ month position ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: clp@alphaconsulting.com

Looking for consumer relations representatives to be able to answer questions over the phone regarding nutritional products and pediatric products. The location will be downtown Columbus and shifts will be 2nd from 2:30pm-11pm and 3rd from 11pm-7:30am.

A degree is a must and preferably in nutrition or related field.

Candidate must have a clean background check and be able to pass a drug test.

Candidate must be extremely professional and have great phone eitiquette.

Manpower is an Equal Opportunity Employer (EOE/AA)

 


Experience in Writing validation protocols and execution in a medical device/IVDD environment QA review of validation packages experience reviewing both reagent and instrument manufacturing packages working on validatioin cross-function teams as QA representative


Experience in Analytical Method Validation and cleaning validation a plus.


Compliance knowledge of FDA and ISO requirements.


GHTF S3 Validation Guidelines a plus.


This candidate will be reviewing and approving a large amount of protocols and reports as part of a special validation program effort.


They will work with cross functional team to design strategy for each validation.


They may have other responsibilities in advising on software validation process and strategy per Abbott SOPs. 


 They may also review on-going daily validation protocols and reports outside the scope of the special validation program effort.

PharmaNet Resource Solutions is the new global alternative for flexible staffing with experienced clinical development professionals.


We currently have an exciting contract opportunity for an Endpoint Management Associate in Blue Bell, PA for a one year assignment.



The Endpoint Management Associate role may include (but is not limited to) the following tasks: 

Receive and review Investigator Record of Potential Endpoint or Event forms from Investigator sites
Follow-up with Investigator sites to obtain additional supporting documentation for potential endpoints or events
Review medical information to ensure completeness of endpoint or event package, blinding of study subject, and to identify any unreported potential endpoints or events
Review Serious Adverse Event (SAE) listings and provide appropriate follow-up with the Investigator site to ensure that all potential endpoints or events have been reported
Assemble endpoint or event adjudication packets for Clinical Events Committee Members
Assist with preparation for periodic Clinical Events Committee Member meetings

 

Project Description:  Client is looking for a Business Analyst with the following:
 
MUST HAVE:
Strong skills writing functional requirements for front end systems
Expertise with Static Lists and ISO Standards
Reference data management experience
 
Pharma experience will be a plus
 
Required Skills:  Business Analyst
 
This 6+ month position starts ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: clp@alphaconsulting.com

Responsibilities Include:



Research and determine customer eligibility as requested by contract department or Group Purchasing Organization.

 

Update, Add, End Date and Attach members to the contract and business units as deemed necessary in CARS / IS.

 

Research CAR/IS data base to check for duplication before setting up customer accounts.

 

Utilize public government information web sites, DEA, HIN, AHA, and PHS to determine if Federal Government Entities, Public Health Facilities, and Group

 

Purchasing Organizations are eligible for a reduced price per contract agreement.

 

Manage and respond to email requests from wholesalers, contracts departments and other internal / external stakeholders.

 

Utilize the Claims Management System (CMS) as needed to associate and offset credits to related debit memos in RCS.

 

Respond to email requests in the teams departmental Outlook mailboxes from both internal and external sources.

 

Archive department documentation as needed.

 

Run daily Work In Progress (WIP) reports in the Business Objects system to determine the chargeback error lines that should be examined

 

Run various reports to be sent to the wholesalers on a weekly or as needed basis.

 

Send Site inspection letters to the customers as needed.

Are you experienced in Quality Assurance and Quality Control testing? If so, then Kelly Scientific Resources (KSR) has an exciting opportunity for you as a Quality Assurance Laboratory Technician! This position takes place at a top food processing and distribution company located in Klingerstown, PA (near Harrisburg).

By working with KSR in this role, you would be eligible for:
A competitive hourly rate (up to $15 per hour, based on experience) with weekly paychecks and direct deposit
Access to newly expanded Medical Plan options
Paid holiday and vacation time
Online continuing education through the Kelly Scientific Learning Center
Employee discounts and a recognition program
And more!

This is a temp to hire opportunity (with the temporary portion lasting 6 months). The hourly rate is $15.00 per hour based upon experience.

As a Quality Assurance Laboratory Technician your job duties will include, but are not limited to:

Receive and prepare raw, in-process, and finished product samples for microbiological, analytical and sensory testing.
Perform qualitative, quantitative, analytical, and sensory testing in accordance with company SOPs thus ensuring the quality of egg products.
Determine if all test results meet established specifications and standards. Report any results that fall out of specification to the proper personnel.
Place any ingredients or finished products that do not meet specification on hold and send out the proper notification.
Perform the release of products and send out the proper notification.
Generate and review COAs as needed.
Prepare and sterilize media solutions as needed.
Wash and sterilize all materials and autoclave biohazards as needed.
Perform environmental swabbing, perform necessary quantitative and qualitative testing on the swabs, and interpret and report results to the proper personnel.
Ensure proper calibration, validation, and maintenance of all lab equipment.
Maintain a clean and orderly work area including all storage areas (i.e. benchtops, freezers, refrigerators, incubators, closets)
Record all data in appropriate notebooks, databases, and spreadsheets.
Actively participate with departmental and cross-functional teams.
Other job duties as assigned.

To be considered for this role, the following are REQUIRED:

Bachelors degree in food science, biology, chemistry, or a related science, or a sufficient amount of education and experience to perform the essential functions of the position.
Knowledge of GMPs, GLPs, and sanitation procedures.
Excellent understanding of microbiological, analytical, and physical methods.
Proficient mathematics skills.
Basic proficiency using computer programs (MS Office) for collecting and analyzing data, and writing procedures and reports.
Basic proficiency using statistical and quality related problem solving tools.
Proficient written and verbal communication skills.
Ability to follow instruction and work both as a team member as well as independently, strong interpersonal skills, and attention to detail.

Are you ready to contribute to a major food distribution company and receive much in return for your skills as a QA Laboratory Technician? Then, take the first step now by clicking the "Submit Resume" link provided! Or, feel free to refer a friend. There is never an application fee.

As the world's leading provider of scientific and clinical research workforce solutions, Kelly Scientific Resources® has been connecting scientific professionals with businesses around the world since 1995. Our international reach allows us to meet our clients' global workforce requirements and provide our employees with global career opportunities ' all while delivering quality localized service through our more than 100 branch locations.

We are a part of Kelly Services®, a US-based Fortune 500 company and a global industry leader in workforce solutions.

Kelly Services, Inc. is an Equal Opportunity Employer.

ASG, Inc. is a global outsourcing and specialty staffing organization that works with companies involved with clinical trials.  One of our clients in RTP, NC is in need of a Drug Safety Associate with Risk Management experience.  This is a six month contract opportunity. 
 
Monitors, tracks, evaluates and reports on risk management activities to the CLIENT Risk Management Team (RMT) including assessment of reports from:
-DAWN LIVE!
-Monitoring the internet for reports of misuse, abuse and diversion; and
-Suspicious physician behavior from NADDI, DEA or field representatives
 
Prepares risk management summary reports for submission to the regulatory authorities
 
Independently reviews and evaluates aggregate safety data from a variety of sources including:
-Adverse event reports from postmarketing sources
-Adverse event reports identified in the literature
-Adverse event reports from post-marketing clinical trials
 
Completes/manages safety signal evaluations for marketed products
 
Prepares summaries of safety data for potential updates to prescribing information or in response to queries from regulatory authorities