Clinical Research Associate
Job Description:
As a member of the Clinical Affairs team and reporting to the Director, Clinical and Regulatory Affairs, he/she will participate in and may lead clinical research programs by assisting with the development of study protocols, case report forms, clinical reports; performing site monitoring visits; and interfacing with site coordinators, field clinical staff, Clinical Research Organizations (CRO), and other company representatives.
Responsibilities Include:
- Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements.
- Assist in designing, planning, and implementing clinical research projects.
- Assist in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process.
- Review study records including case report forms, consent forms, and other materials.
- Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements.
- Organize data in systematic manner to allow for efficient and accurate clinical reports.
- Perform site visits to ensure regulatory and study requirements are being fulfilled.
- Provide on-site support in the operating room during clinical study procedures.
- Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
- Assist in writing the clinical study report as well as the clinical portion of Regulatory submissions.
- Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
- Perform other clinical duties when requested.
Qualification Requirements:
- Bachelor’s degree in health profession, science and/or engineering field.
- Two to five years of clinical affairs experience in the medical device or pharmaceutical industry. Pharmaceutical experience preferred.
- Excellent written and oral communication skills.
- Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
- Excellent organizational skills and attention to detail.
- Some travel would be required for site training, clinical study procedure support, monitoring responsibilities and educational seminars.
- Ability to travel approximately 35-40%.
Quality Engineer
Job Description:
Work with other departments to ensure quality of combination products (medical device with drug) and drug delivery product processes. May be responsible for generating risk analysis documents, performing validations, supporting in-house manufacturing, investigating quality issues or product complaints, performing quality audits, or developing new procedures/methods.
Responsibilities Include:
- Participate on drug delivery product project teams as the quality representative.
- Interface with R&D to ensure that drug delivery products are designed for patient safety in terms of FMEA, risk analysis, toxicology, Quality System compliance, and manufacturability.
- Support activities related to drug delivery product development, validation, process validation, and in-house manufacturing.
- Investigate current or potential quality issues and implement corrective/preventive actions.
- Perform operational, laboratory, and product complaint investigations.
- Coordinate calibration activities.
- Develop and implement Quality System policies and procedures.
- Perform internal audits and supplier audits.
- Perform other quality engineering duties as assigned.
Qualification Requirements:
- Excellent organizational skills and attention to detail.
- Strong communication skills.
- Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
- Ability to provide scientific judgment.
- General knowledge of statistics (i.e. sampling plans).
- Understanding of drug cGMPs.
- Experience working in clean room preferred.
- Bachelor’s degree in an engineering or other relevant scientific discipline.
- 2-5 years in pharmaceutical or related work experience.