Careers
Career Opportunities
ClinSmart is an equal opportunity employer. In addition to offering a dynamic work environment, ClinSmart offers a competitive compensation package, including health coverage, dental plan, Short Term Disability and Life Insurance,
Please review our currently open positions to become a part of the ClinSmart team.
If you are interested in exploring career opportunities at our office located in Langhorne, Pennsylvania please mail, fax, or email your resume, including salary history, to:
dklementowich@clinsmart.com |
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Open Positions
Click on the positions below for more information.
Regional Clinical Research Associate (CRA)
Clinical Trial Assistant (CTA)
Clinical Data Manager
Regulatory Associate
Regional Clinical Research Associate (CRA)
Responsibilities:
- Screen and recommend investigators
- Attend investigator meetings
- Conduct pre-study initiation visits
- Orient site personnel to study protocol and procedures
- Perform on-site and on-line site monitoring activities from study start-up through close-out
- Verify accurate transcription of data from source documentation to CRF/EDC
- Oversee drug accountability
- Ensure regulatory inspection readiness at assigned clinical sites
- Perform all duties and responsibilities in adherence to protocols, FDA regulations, ICH/GCP guidelines, and company SOPs
- Perform other related duties as required
Qualifications:
- Minimum of 3 years experience as a Regional CRA
- Extensive knowledge of FDA regulations and GCPs
- Computer proficient with EDC experience
- Detail oriented
- Excellent verbal and written communication skills
- Ability to work independently with minimal supervision
- Ability to proactively identify issues that may impact enrollment and recruitment timelines
- Ability to travel up to 80%
Clinical Trial Assistant (CTA) - PART-TIME
Responsibilities:
- Collect and maintain in-house required study documentation
- Prepare and maintain study site binders
- Maintain trial master files
- Participate in selection and oversight of vendors
- Oversee the grant process
- Assist with CRA Travel Arrangements
- Perform other related duties as needed
Qualifications:
- BS/BA or equivalent
- Minimum of 2 years Clinical Trial experience within the pharmaceutical or biotechnology industry
- Working knowledge of FDA regulations, GCPs, clinical study documentation, TMF
- Computer proficient (knowledge of Microsoft Outlook, Power Point and Excel)
- Excellent verbal and written communication skills
Clinical Data Manager
Ideal candidate must be able to manage all aspects of the data management process from study start-up through database lock; have strong experience in EDC, possess the ability to work closely with vendors and project teams to ensure quality data; have project management skills so that all milestones and deadlines can be met in a timely fashion.
BS (or equivalent experience) in life sciences or a similar discipline is required with a minimum of 4 years of data management experience. If interested and qualified, please e-mail your resume along with salary requirements to: dklementowich@clinsmart.com.
Regulatory Associate
Under some guidance, prepares regulatory applications and submissions such as Annual Reports, amendments, supplements, INDs, ANDA's, NDA's, and FDA control documents in accordance to FDA guidelines. Represent Regulatory Affairs on project teams. Provides assistance to Sr. Management, as necessary.
Skills/Knowledge Required:
- Completed Bachelor's degree in LifeSciences, Chemistry, or Pharmaceutical Science required.
- Must have at least 2 years in an FDA regulated industry with minimum 1 year in regulatory affairs or quality assurance.
- Knowledgeable of current pharmaceutical industry and applicable regulations.
- Strong ability to compile, manage, and interpret data.
- Excellent oral and written communication skills.
- Ability to communicate effectively, make presentations and write concise reports for different levels of employees.
- Advance knowledge of computers including word processing, spreadsheets, graph/charts, and databases.
- Experience in eCTD submissions preferred.
- Experience with product development projects, and ensure compliance with all regulatory requirements pertaining to product development and approval.
If interested and qualified, please e-mail your resume and salary requirements to: dklementowich@clinsmart.com.