Pharmacist/Research Quality Specialist

Diablo Clinical Research (DCR) is as an independent, dedicated research facility that has operated out of its Walnut Creek location for over 26 years. We are looking for a licensed pharmacist who is searching for that career opportunity that will allow them to continue to use their pharmacy skills but become an integral part of a research facility as part of our quality assurance team.

The job is approximately 30% pharmacy (primarily mixing, administering, verifying, administrative work for vaccines (COVID, pneumonia, flu, RSV, CMV, etc.) but also other injectable medications for diseases such as celiac, diabetic peripheral neuropathy and more. The other 70% of the time is spent on quality review of our clinical research studies across all of our therapeutic areas (diabetes, weight loss, healthy volunteer, device studies, etc.).

This position is ideal for a trained pharmacist as your knowledge of diseases and medications is directly applicable to chart review and auditing of medical records. You will be joining a team of 2 other pharmacists in our quality group as well as direct support for our FT pharmacist in our pharmacy department.

The most successful candidates will: (1) feel confident with data entry programs across multiple platforms, (2) be familiar with medications and medical conditions and (3) have some background in quality assurance/auditing.

We work with all of the major pharmaceutical companies (and many of the smaller biotech and high tech companies) across multiple therapeutic areas: diabetes, weight loss, vaccines (COVID, RSV, pneumonia, CMV, flu) pain (OA, migraines), device studies (CGM, artificial pancreas, wearables/fitness devices) and more. Our drug studies are primarily Phase 2 and 3 but we have an active Phase 1/inpatient unit on site as well; our device studies range from simple single visit outpatient studies to extensive in patient and overnight observation studies.

Our staff is comprised of 3 MDs (2 endocrinologists and 1 internist), 1 PA/CDCES, 4 clinical research coordinators, 3 regulatory specialists, 4 quality specialists, 1 lab specialist, 1 registered dietician, 1 FT pharmacists, 4 research assistants plus additional administrative and management staff to support the accurate and timely execution of our study protocols.

Duties for the Quality Specialist are primarily review of clinical data (patient chart review for accuracy of data collection, review of informed consents for accuracy and completeness) and data entry across multiple digital platforms. Our Quality Specialist will attend trainings performed by the Sponsor/pharmaceutical company as well as internal training by our medical staff for the disease states we treat and for the protocol specific requirements. We are committed to growing our employees knowledge and expertise in clinical research conduct.

More specific job duties for the Quality Specialist will include:
* Reviewing protocols for identification of source document information

* Reviewing completed source documents for accuracy and completeness

* Entering data into multiple electronic data capture (EDC) systems

* Reviewing data already entered into EDC (QC'ing data entry)

* Assisting with targeted data audits

* Reviewing Informed Consents for accuracy and completeness

* Assisting Pharmacist/Pharmacy Technicians with IP audits

* Supporting Clinical or Recruitment Departments with quality activities on an as needed basis

* Attending training and educational meetings

More specific job duties for the Pharmacist part of the position include:

* Second pharmacist and primary pharmacist for all studies as needed

* Mixing, administering, verifying all studies that require pharmacist support (typically all unblinded studies and other compounds that must be mixed in a sterile environment - we have a hood on site for sterile mixing)

* Administrative duties as needed for pharmacy documentation per study

Qualifications for this position:
* Bachelor's Degree from four-year College or University

*Current Pharmacy License
* Computer proficiency (MS Office, specifically excel)
* Attention to detail
* Excellent interpersonal and communication skills
* Positive attitude, flexibility and reliability

We have an excellent PPO health care plan, a 401(K) with company match, a profit sharing plan, standard vacation and sick pay and more.

Job Type: Full-time

Typical end time:

• 4:30PM

Typical start time:

• 8AM

Work Remotely

• No

Job Type: Full-time

Pay: $40.00 - $45.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Retirement plan

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
Daily check in for fever/symptoms for staff and patients. Staff and patients must wear masks (we are healthcare facility). Full vaccination and booster documentation required.

Education:

• Bachelor's (Required)

Experience:

• pharmacist: 2 years (Preferred)

License/Certification:

• Certified Pharmacist (Required)

Work Location: One location