Clinical/Patient Support Specialist (Raleigh Pharma) – Direct Hire/Top $
Our client, a Raleigh-based pharmaceutical company that specializes in the development and distribution of therapies for the treatment of rare diseases, has an immediate need for an exceedingly sharp candidate to join its Clinical Operations team. This position will support both commercial and developmental products, and we seek a skilled and versatile point-person who can juggle it all.
Company will pay excellent wage for excellent person.
Key Things to Note:
- Company provides diagnostic services as well as product distribution services. This Specialist will interface with patients, specialty pharmacies, healthcare providers, caregivers, etc., to ensure proper delivery, support, training, and follow-through on both the diagnostic tools and drug delivery.
- Company also runs clinical trials for other products/indications (some investigator-led, some company-sponsored). This Specialist will provide In-house CRA-type support for these trials.
- This role will involve extensive (mostly telephonic) work with patients. Some experience as a nurse or other healthcare clinician would be valuable.
- Early products focus on gastroenterological diseases. Familiarity would be a plus.
- This company is in start-up mode. Policies and practices are established but evolving. Seek quick study who will rapidly understand and effectively execute SOPs and will contribute to enhancements.
- This is a small office of a larger company. Seek flexible and resourceful candidate who will help where the help is needed.
- Travel is estimated to be between 25 – 50%, depending on trial needs.
Commercial Operations Support
- Provide commercial and research diagnostic support and training to healthcare provider clinics and study sites. Serve as a primary point of contact.
- Support sales and marketing teams developing materials for internal and external training programs
- Ensure logistics (sample collection, storage, and shipment), procedures and processes are implemented and followed
- Serve as a resource for the specialty pharmacy in supporting patients and healthcare providers
- Collect and document reported adverse events and product complaints per corporate SOPs
Clinical Trial Support
- Recruit and enroll study participants and/or assist study sites with recruitment strategies
- Serve as a resource for study participants
- Review study-related materials including case report forms (CRF), protocols, informed consents, etc.
- Monitor study sites and activities to ensure protocols and terms of the study are being followed
- Manage essential documents before, during and after a clinical trial
- Assist project teams with oversight of sponsored, collaborative, and investigator-initiated trials
- Assist in the preparation of project publications/tools, and sharing ideas/suggestions with team members
Selected candidate will offer a BA/BS in scientific field or a nursing degree as well as 2+ years handling similar clinical support work in an emerging pharmaceutical/biotech setting. Experience as a study coordinator or on-site are desirable. Experience as a nurse or other clinician strongly preferred.
Other priorities include:
- Exceptional organizational skill
- Superior knowledge of ICH/GCP/HIPAA and other related industry regulations and practices
- Clear, thorough, accurate, compassionate and timely communication skills
- Keen attention to detail and compliance-orientation
- MS Office proficiency
- Gastro knowledge a plus
Finally and critically we seek a candidate who brings the flexibility, resourcefulness, adaptability, collaborative work style and “how can I help?” demeanor to thrive in this emerging company. A lot is happening and the future is bright. We seek a high potential candidate who will grow with the company.
Please forward Word resume for prompt consideration. Local candidates only.