Research Pharmacist

POSITIONPURPOSE

Oversight of pharmacy operations and pharmacy staff. Oversees all aspects of protocol related investigational Product (IP) procedures according to Good Clinical Practices (GCPs,) Standard Operating Procedures (SOPs) , FDA guidelines and all applicable rules and regulations.

ESSENTIAL FUNCTIONS /FUNCTIONS /PRINCIPAL ACCOUNTABILITIES

• Performs all job responsibilities in accordance with standards of good clinical practice, clinic SOPs, OSHA guidelines, Federal and local regulations
• Completes all required training programs per company requirements
• Honors password protections
• Reads and has knowledge of study protocols and Investigators Brochure (1B)
• Timely evaluation/sign-off of study documentation
• Performs competencies as trained and as applicable to study protocols
• Reports to Medical Director for administrative, logistical and staff related site issues.
• Responsible to the Principal Investigator (Pl) on all aspects of study conduct for specific studies
• Ensures study participants confidentiality and HIPM compliance
• Attends Site Initiation Visits (SIV), Eligibility and other meetings as required

As per Job Description and as trained and delegated by the Medical Director or Principal Investigator and as allowed by sponsor.

• Reads new study protocols and amendments with focus on investigational Product (IP) storage, blinding codes, dispensing, dosing, accountability, disposition and concomitant medications requirements
• Follows protocol instructions on dispensing/storage/return of drug
• Prepares and maintains pharmacy documents
• Maintains study related pharmacy correspondence
• Assists with pharmacy and concomitant medication SOP development and revisions
• Trains study staff, if appropriate, in pharmacy and dosing related matters
• Responsible for drug receipt, storage, destruction and return and maintaining adequate documentation
• Ensures accurate drug dispensing and accountability
• Secures and maintains storage of IP blinding codes immediately upon receipt
• Participates in concomitant medication review and identification
• Prepares and accurately labels IP containers and concomitant medication packaging for dispensing.
• Performs chain of custody documentation to track IP between Principal Investigator (Pl) site and off-site storage/transfer/disposition
• Promptly reports issues related to IP controls, integrity, systems or to clinic management
• Maintains on file current business licenses for any vendor performing IP disposition
• Ensures used and unused IP are stored separately and each protocol IP is stored separate
• Ensures ingress/egress controls to pharmacy
• Ensures recordkeeping for damaged/adulterated IP and quarantine measures
• Ensures cross-check of all documentation from the IP shipper to ensure protocol and lot number match actual IP label
• Checks expiration dates and notifies sponsor in advance of upcoming expiration or inconsistencies between labels and IP receipts logs/forms
• Ensures legible photocopy(s) of IP labels for new lot number and each label change is placed in IP accountability file
• Ensures if bulk IP is provided by Sponsor, verification of: Certificates of Analysis (CoA), that CoA lot numbers reflect lot numbers on bulk product (e.g., unpackaged capsules). Verifies lot numbers match between release documents and packaged lot numbers.
• Ensures Material Safety Data Sheet (MSDS) for each compound provided by sponsor is on file, if not provided
• Ensures monitoring of temperature/humidity and periodically checks recorder devices for function. Documents and reports deviations from IP storage protocol specifications immediately upon discovery to sponsor, the Pl and Medical Director and study staff
• Document sponsor directives re: use or return of affected IP study participated to deviations in temperature or, humidity. Immediately notifies Facilities Manager re: environmental facility issues affecting IP storage conditions. Document’s notification time/ action taken
• Returns, disposition or destruction of IP and documentation as per Sponsor directive
• Ensures training is documented for pharmacy dispensing staff, back-up dispensers and IP QC study staff
• Ensures IP accountability is conducted with Sponsor monitor and reconciliation of discrepancies occurs
• Ensures clean/orderly pharmacy, cleaning pharmacy hood, IP counting trays/spatulas per manufacturer instruction
• If applicable, compliance with DEA regulations for storage of scheduled drugs and registrations
• If applicable (e.g., in the case of a BA/BE study) that sponsor provides guidance on retention samples
• Follows rules for waste segregation as they pertain to pharmaceutical grade waste
• Performs and ensures staff performs competencies as trained and as applicable to study protocols

Basic Qualifications:

• Pharmacy Degree (e.g., PharmD)
• Current valid NC Pharmacy license
• Two years’ experience in a clinical and/or medical environment
• Knowledge of FDA regulations/standards/guidelines
• Excellent verbal, written, and organizational skills with a team-oriented approach
• Focused to handle multiple tasks with accuracy to meet deadlines in fast paced environment
• Proficiency in MS Office and Lotus notes

DESIRABLE EXPERINCE AND SKILLS (IF APPLICABLE)

Preferred Qualifications:

• Phase 1 Clinical Trial experience
• Leadership skills, ability to take initiative, work independently and collaborate in teams
• Strong interactions or work experience in research trials
• Strong organizational, supervisory, and interpersonal skills
• Ability to interact positively with all levels of staff and liaise successfully with all levels of management.
• Able to represent HPCTC in a professional manner at community events

Job Type: Part-time

Pay: From $30.00 per hour

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Day shift
• Monday to Friday
• Night shift
• Weekend availability

Education:

• Master's (Preferred)

License/Certification:

• Pharmacist license (Preferred)

Work Location: One location