Clinical Research Associate

Company Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

​Job Description:

• Ensure compliance with ICH – GCP guidelines and all pertinent government regulations for conducting clinical studies.
• Assist in preparation of protocols and documentation for clinical studies, entailing communication with consultants such as surgeons, radiologists and outside statisticians.
• Assist in the IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations.
• Contribute to overall data management such as case report form design, edit check review, data clarification process and evaluating and analyzing clinical data
• Recruit, qualify and train investigators and clinical site personnel (and laboratories, as applicable) for study participation.
• Assist with contract and budget preparation and negotiations.
• Coordinate activities of investigators and clinical site personnel to ensure compliance with the protocol and overall clinical objectives.
• Coordinate the organization of study regulatory files, inventory and all related study materials and supplies.
• Assure data integrity through proper on site monitoring, verification of source records, documentation of protocol deviations, and completion of written reports, in accordance with department Standard Operating Procedures (SOPs).
• Communicate with clinical sites to expedite the exchange of information and to ensure that clinical studies are kept on schedule and within budget.
• Assist with the implementation of investigator meetings and general clinical meetings (as applicable).
• Ensure subject safety in all areas of clinical research, following procedures to report AEs, SAEs and UADEs to clinical, regulatory and quality management.
• Contribute to obtaining government approvals and preparing progress reports for clinical studies.
• Promote good communication with investigational sites, within the clinical department, as well as between other Integra department members.
• Assist R&D, marketing, and other departments in performing their duties, as appropriate.
• Maintain awareness of current issues in clinical research by reading relevant literature and attending industry meetings and other training opportunities.
• Assist in various projects and other duties as assigned.

 Qualifications:

• Education: Bachelor’s degree, preferably in a life science or scientific related field, or RN or BSN degree or 10 years of recent and relevant clinical research/monitoring experience.
• Experience: Four year or more experience in clinical research, with a minimum of two to four years’ experience in independent coordination of investigational site activity by on-site monitoring and site communications.

Specific competencies:

• Intermediate knowledge and understanding of FDA regulations and ICH – GCP guidelines.
• Must work both independently and in a team environment.
• Proven track record of on-site monitoring of investigational sites and constructive site collaboration.
• Ability to review and interpret medical records through knowledge and general application of medical terminology.
• Excellent interpersonal, written communications, time management, and organizational skills.
• Detail oriented with good problem solving skills.
• Ability to manage multiple tasks and take ownership and workflow initiative.
• Proficient computer skills using Microsoft Office products.
• Experience with electronic data capture (EDC) is a plus.
• Presentation skills desired. PHYSICAL REQUIREMENTS:  The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

Skills and Certifications:

• Bachelor’s degree, preferably in a life science or scientific related field, or RN or BSN degree.
• Four year or more experience in clinical research.

Qualifications

• Bachelor’s degree, preferably in a life science or scientific related field
  

Additional Information

• Good working knowledge of project management activities.
• Interpersonal and professional skills to interact at all levels including senior executives, contractors and colleagues.
• Good written and verbal communication skills and ability to present and critically discuss data in both internal and external discussions.
• Highly organized, with exceptional good analytical and reasoning capability, ability to multi-task and prioritize.
• Thorough knowledge on analytical & numerical skills.