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
Human Resources
ClinSmart, LLC
3000 Cabot Boulevard
Suite 200
Langhorne, PA 19047
Fax: 215.702.2899
Open Positions
Click on the positions below for more information.
Project Manager
Clinical Data Manager
Assistant Director, Clinical Research
In-house Clinical Research Associate (CRA)
Regional Clinical Research Associate (CRA)
Project Manager
Responsibilities:
- Coordinates and manages clinical trials from start-up to closeout
- Liaises with internal departments to ensure adequate resources are available
- Manages study objectives and budgets of assigned projects
- Maintains good working relationship with the clients
- Requests and manages project change orders on an as-needed basis
- Assists in the development and review of sponsor cost estimates and proposals
- Meets face-to-face with clients, including attendance at bid defenses as needed
Qualifications:
- Bachelors degree in life sciences or another discipline with a minimum of 3 years experience in a project management role
- Experience in clinical trials preferred
- Excellent organizational, communication, and data management skills (detail oriented)
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Experienced in computer applications including Word, Excel, Access, PowerPoint, Microsoft Project
- Minimal travel required
Clinical Data Manager
Responsibilities:
- Review and validate clinical research data
- Identify, query and resolve missing or discrepant data
- Develop and maintain case report forms (CRFs), data management plans, validation specifications, and study guidelines
- Ensure ongoing data entry from CRFs or other sources into the clinical trial database within agreed time frames and a high standard of accuracy
- Contribute into the design and usability testing of new databases and validation programming
- Develop and maintain a close liaison with client contacts and project team members to drive the data management aspects of project delivery
Qualifications:
- BS (or equivalent experience) in life sciences or other discipline with a minimum of 5 years data management experience
- Working knowledge of Good Clinical Practices (GCP) and ICH regulations
- Familiarity with medical terminology and dictionaries
- Excellent oral and written communication skills
Assistant Director, Clinical Research
Responsibilities:
- Provides medical leadership and guidance for clinical research projects
- Provides medical and scientific feasibility of all new sponsor inquires
- Plans and implements clinical trials in conjunction with the Clinical Research Dept.
- Review and evaluate protocols and provide clinical and scientific support
- Functions as a liaison between sponsor and consultants / key opinion leaders, regarding study design and conduct, as needed
- Performs reporting and assists with regulatory filing for clinical studies
- Attends client, FDA and Business Development meetings, as needed
- Assists with sponsor visits
- Travel may be required
Qualifications:
- M.D. degree with completion of residency; fellowship training preferred
- Strong familiarity with clinical trials required
- Additional experience in clinical medicine, pharmaceutical medicine, translational research and/or regulatory affairs supported by publications preferred
- Excellent oral and written communication skills
In-house Clinical Research Associate (CRA)
Responsibilities:
- Responsible for the maintenance of internal trial master files to ensure inspection readiness
- Participates in the development of study documentation such as protocols, amendments, informed consents, study reports, case report forms, and validation rules
- Assists in the evaluation, selection and training of investigators
- Participates in the selection and oversight of vendors
- Oversees investigational product and ancillary supply shipments and dispositions
- Participates in the negotiation of site budgets and oversees the grant process
- Attends investigator meetings and presents project-related information if necessary
- Monitors, trains and mentors other CRAs as required
- Performs other related duties as needed
Qualifications:
- Extensive knowledge of FDA regulations, GCPs, and clinical study documentation
- Computer proficient with EDC experience
- Detail oriented
- Excellent verbal and written communication skills
- Ability to proactively identify issues that may impact enrollment and recruitment timelines
Education and Experience:
- BS/BA (or equivalent) in Life Science or Nursing required
- Minimum of 3 years CRA/monitoring experience within the pharmaceutical or biotechnology industry
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:
- 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
Education and Experience:
- BS/BA (or equivalent) in Life Science or Nursing required
- Minimum of 3 years CRA/monitoring experience within the pharmaceutical or biotechnology industry