Company/Organization: Qtech-Solutions Professional Development Center

Description:

(Prior training will be provided for preparation in accordance to below Tasks and responsibilities)
The internship will consist of “real world” documentation and case study scenarios that represent on the job applications.

Major Tasks and Responsibilities: (Learnings)

• Review the contents of Investigator Brochure and Provided generalized brief and short explanation for each of the Content like What kind of information/Data included in that particular section.
• Provide detailed explanation about the type of the information to be included in the each section of the IND application.
• Work on situational GCP priority case scenarios from Investigational site and addressed the concerns
• Review Regulatory requirement criteria for IRB protocol review standards and provided missing information for regulatory requirements
• Review application for Human subject research and provided missing in each part of application
• Provide description for each element covered in clinical trial protocol.
• Review the protocol for Phase II double blind placebo controlled clinical trial and provided outline for each section of the protocol
• Develop per patient budget cost sheet upon reviewing a protocol for Phase II clinical trial.
• Identify and classify discrepancies upon performing manual review of CRFs and prepared quality control report
• Review artifacts from Trial Master Files and provided list and purpose of core/recommended documents pertaining to each zone of TMF
• Review the Informed consent form and identified discrepancies
• Provide missing entries in Informed consent form upon reviewing Phase II clinical trial protocol summary
• Identify correct order as per standard IRB format for monitoring visit report upon reviewing Monitoring visit report
• Review the monitoring visit findings and determined the discrepancies
• Upon reviewing the Phase II Clinical trial protocol prepared a Power point presentation by detailing the Objectives, end points, inclusion exclusion criteria, visit schedule, drug accountability and other details covered in the protocol for investigator meeting.
• Provide brief outline for the each section to be covered in the Site initiation checklist
• Provide definition purpose of each artifact pertaining to Site Management Section in standard TMF (Trail Master File) reference model
• Review adverse events case scenarios from clinical trials and identify safety issues and reporting timelines

Qualifications:

Educational Qualifications:
• Healthcare professionals (e.g. RN, PA, MD, PT.RPh, PharmD, Medical Technologist)
OR
• Preferred degree in: Pharmacology/Toxicology, Pharmacy, Industrial Pharmacy, Pharmaceutical Chemistry, Public Health/Medicine, Medicine, Nursing,
OR
• Bachelor degree or higher in life science or Biological sciences
• Information Technology background

Other Qualifications:
• 0-6 months of experience in the pharmaceutical/healthcare industry (clinical trials)
• Strong verbal and written communication skills
• Willingness to get trained
Candidates with more than 2 years of experience will not be considered for training/internship program, but will qualify for training and placement assistance program only. Upon completing training internship program our candidates might be considered for placement assistance and contract position.

Other Conditions
• Upon the training internship program each Intern will also receive job preparation support, which includes: resume writing, interview tips as guidelines, narrative preparation, mock interviews with experienced Drug Safety Professionals
• Job placement assistance will be offered for qualified candidates after internship program while the success rate will depend on the candidates performance during the internship program
• NO INTERNSHIP RELOCATION is required

Length/Availability:

60 days

Start Date:

10/25/14

End Date:

12/25/14, 12/25/14

Additional Info:

CONNECT WITH US TO GROW YOUR CAREER!
Clinical Science and SAS Analytical Domain which is very rewarding field and at the same time it is rapidly expanding for job opportunities.
This field is always in demand and look for candidates with
• Clinical Research / Data Management.
• Pharmacology or Toxicology degree.
• Pharmacy (or) Pharmaceutics (or) Industrial Chemistry degree.
• Public Health degree.
• Biotechnology / Bioinformatics degree.
• Medicine / Nursing degree
• Statistics, Bio-statistics degree
• Computer Science and Engineering

JOB ORIENTED TRAINING & PLACEMENT PROGRAMS
Training Highlights
• 24/7 Access to the Training Material
• In class Trainings (Optional)
• Job Oriented Training
• Hands-on Experience
• Technical Support
• Resume Preparation
• Mock Interviews
• Placement Support

POST TRAINING JOB SUPPORT

Qtech offers Placement assistance support to candidates meeting the eligibility criteria upon successful completion of training. Email us your most recent resume to get enrolled into placement support program and qualify by securing minimum score points needed to qualify. We assist candidates in resume preparation, narrative writing and conduct mock interviews for increased success rate of each candidate.

We will get you prepared for jobs open in market and for possible interviews. Please keep in mind the success rate solely depends on candidate’s performance, job market, experience, technical expertise, and writing and communication skills.

Tags:

Clinical  Research  Associate  pharmaceutical 

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