The IDS Pharmacy Manager advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care.

The IDS Pharmacy Manager is responsible for evaluating, hiring, and training new staff.

Protocol Compliance

• Reviews potential future protocols for feasibility and attends weekly protocol review meetings.
• Attends site initiation visits.
• Participates in quality control checks for study-specific forms, both for new studies and for protocol updates.
• Creates IDS specific training documents for staff for new protocols using the IDS template.
• Reviews all investigational protocols, amendments, and clarification letters.

Medication Dispensing and Preparation for Conventional and Investigational Products (IP)

• Reviews all orders for accuracy of dose and dose calculations.
• Reviews patient-specific factors to determine eligibility for treatment.
• Develops compounding tools for all IV investigational agents and trains technicians on mixing process for all IP and conventional agents, if required.
• Checks all IV and PO doses prepared by the IDS Pharmacy technician.

Management of Investigational Product and Drug Accountability

• Maintains responsibility for the management of the inventory for protocols, including ordering, receiving, and returning IP, as required.
• Ensures that correct procedures for receipt of IP and storage of IP are followed.
• Maintains appropriate and accurate records for all protocols.

Administrative and Supervisory Responsibilities

• Provides direct supervision and training to IDS pharmacists and pharmacy technicians.
• Complies with NEXT Oncology SOPs and Workflows.
• Contributes to the development, integration and monitoring of written procedures and workflows covering all aspects of the IDS.

Education Responsibilities

• Orients IDS staff, pharmacy residents and pharmacy students to the IDS role with respect to protocols, as required.
• Maintains continuing education requirements to maintain Pharmacy and Preceptor License, any certifications and protocol compliance training.

Data and Document Management and Information Technology

• Assists in the scanning, review and uploading of protocol documentation into eDOCs.
• Uploads resume, license(s), certification(s) and training documents for IDS employees into eDOCs.

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The IDS Pharmacist plays a critical role in ensuring protocol integrity, patient safety, and regulatory compliance throughout the conduct of clinical trials.

Key Responsibilities

• Review protocols, amendments, and study-specific documentation; attend site initiation visits; ensure accurate medication screening and documentation.
• Verify dosing accuracy, oversee compounding of investigational products (IP), and ensure compliance with USP <797> and <800>.
• Maintain inventory, manage drug receipt and returns, ensure proper documentation in Vestigo, and support monitoring visits.
• Supervise IDS technicians, maintain SOP compliance, support audits, and contribute to staff training and performance evaluations.
• Orient new staff and maintain required certifications and licenses.
• Upload and manage protocol documentation and staff credentials in eDOCs and Vestigo.

Minimum Requirements

• Current Pharmacy License in Texas or Virginia (required)
• Pharmacy Preceptor License (preferred)
• IV Certification (preferred)
• Chemotherapy Certification (preferred)
• Strong knowledge of GCP, GMP, USP <797> and <800>, and clinical trial regulations
• Ability to lift up to 40 lbs and perform duties requiring manual dexterity and extended periods of sitting/standing

Why Join Us?

At NEXT Oncology, you’ll be part of a mission-driven team advancing cancer research and patient care. This role offers the opportunity to work closely with leading investigators and contribute meaningfully to clinical trials in a supportive and collaborative environment.

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The Clinical Trials Budgets Analyst (BA) is responsible for preparing, reviewing, and finalizing all budgets and contracts received by NEXT. The BA will serve as the primary point of contact for budget negotiations for studies they are assigned to.

Key Responsibilities:

• Serve as the main point of contact for Sponsors and CROs
• Prepare budget templates for upcoming studies and amendments based on standard costs, ensuring all procedures performed are reflected in the budget grid
• Communicate with sponsor/CRO and internal NEXT team on the status of budget negotiations
• Compare budget changes received from sponsor/CRO to ensure appropriate changes were made as agreed upon
• Exhibits polite and professional communication via phone, e-mail, and mail

Requirements:

• Bachelor’s degree in Business Administration, Economics, Legal or equivalent
• Minimum of two (2) years’ experience working on development of budgets, amendments, proposal development or related field in a biotech or CRO, finance and/or legal environment
• Previous budget development and negotiation experience is a plus
• Knowledge of software including Microsoft Word, Excel, and Outlook, Microsoft PowerPoint, and Adobe Acrobat
• Bilingual in English and Spanish, Portuguese, or Japanese with reading and writing capability is preferred but not required

What We Offer:

• Competitive salary range: $43,900.00 - $109,600.00 per year
• A supportive culture, strong communication, and commitment to excellence in clinical research
• Opportunities for professional growth and development in a mission-driven team

Why Join Us? At NEXT Oncology (an Avacare Business), you’ll be part of a mission-driven team that values collaboration, precision, and patient safety. Our team is known for its supportive culture, strong communication, and commitment to excellence in clinical research.

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The Research Coordinator assists with screening patients, scheduling and overseeing all on-study requirements, and attending study teleconferences with sponsors and clinical research organisations.

Protocol Compliance

• Identifies primary and secondary study objectives and outcome measures
• Adheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research
• Complies with NEXT Oncology SOPs
• Participates in providing timely, informative, and accurate communication with the interdisciplinary team to ensure protocol compliance and timelines of protocol-related procedures
• Collaborates with the Principal Investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs
• Provides protocol-specific education to clinical staff
• Facilitates and participates in the preparation for and conduct of meetings/teleconferences with sponsors, monitors, and auditors
• Provides timely, accurate, and complete reporting of serious adverse events, unanticipated problems, deviations, violations, and noncompliance to the IRB and sponsor
• Contributes to the development of corrective and preventive action plans for unanticipated problems, deviations, violations, and issues of noncompliance

Informed Consent

• Identifies and intervenes to address barriers to effective informed consent discussions and decision making
• Describes and abides by institutional policy and processes for informed consent
• Ensures that the most current version of the IRB-approved protocol consent document is used by the physician investigator when consenting or re-consenting a patient
• Collaborates with the physician investigator to ensure initial and ongoing consent process is performed and documented
• Assesses ongoing consent through discussions with patients and reinforcement of education
• Assesses patient's understanding of the information provided during the informed consent process
• Ensures timely re-consenting as needed by the physician investigator
• Demonstrates understanding of tiered consent process when optional correlative studies are involved
• Confirms informed consent is obtained prior to performing any study-specific tasks

Management of Clinical Trial Patients

• Collaborates with the investigator to ascertain study patient eligibility for a clinical trial
• Educates the patient and family regarding protocol participation
• Provides patient education regarding required study procedures
• Coordinates, schedules, and ensures timely completion of protocol-required events and other requirements
• Assesses individual patients for physical, psychosocial, and financial factors that could impact adherence with study requirements and implements interventions as necessary
• Evaluates patient's adherence to and documentation of self-administered protocol agents and return of such agents
• Collaborates with the investigator to determine disease response and communicates findings to the study team and other care providers
• Ensures appropriate communication between research and clinical staff related to patient-specific care needs
• Ensures evidence-based symptom management as permitted by the protocol

Documentation and Document Management

• Documents all patient encounters in the legal medical record per licensure and institutional requirements
• Obtains documents from outside providers or laboratories that are needed as part of the research data
• Educates other research team members and clinical staff regarding appropriate and accurate source documentation for patients in clinical trials
• Assesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents
• Maintains the privacy and confidentiality of patients' source documents
• Maintains specified study documents in the Research Coordinator files
• Participates in the development of approved source documents, templates, or forms

Data Management and Information Technology

• Adheres to the data management plan per NEXT SOPs and sponsor data management plan
• Assists in troubleshooting data entry issues
• Ensures that relevant data from source documents are abstracted and entered into CRFs in a timely and accurate manner
• Ensures that data recorded on the CRFs can be verified within the source documents
• Participates in quality control activities to ensure data integrity
• Enters data into electronic data capture for SAEs as appropriate

Required Education and Experience

• Typically requires 5 or more years of experience
• Current Texas or Virginia Registered Nursing License for RNs
• Bachelor's degree required for non-RNs
• Oncology clinical trial experience preferred
• Research Coordination experience preferred

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Oncology Care Practices

• Demonstrates knowledge of age-specific differences in the patient population, including physiological and developmental differences unique to each group.
• Assesses and monitors therapy of patients using appropriate technical skills under the direction and supervision of a physician.
• Assists physicians with exams and procedures.
• Maintains efficient and appropriate patient flow.
• Demonstrates knowledge of reimbursement procedures and charge capture.
• Performs venipuncture, accesses implanted ports, and maintains central venous access devices and alternate delivering systems.
• Documents all elements of care.
• Communicates all pertinent information and any interventions to the physician or mid-level provider.
• Serves as a resource person to medical assistants and LPNs.
• Triages patient/family phone calls as needed and documents relevant information in the patient's chart.
• Assesses patient/family needs and provides teaching.
• Demonstrates awareness of community resources available to patients and assists with referrals if necessary.
• Follows OSHA guidelines when handling cytotoxic agents, biohazardous waste, and any other material potentially infected with a blood-borne pathogen.
• Maintains current knowledge of oncology nursing by participating in ongoing educational opportunities.
• Participates in professional development activities and maintains professional affiliations.
• Maintains patient confidentiality.
• Serves as a mentor/preceptor and provides day-to-day guidance to less experienced nurses.

Oncology Clinical Trial Practices

• Confirms informed consent is documented prior to performing any study-specific tasks.
• Identifies patients who require increased nursing assessment and management in addition to the clinical trial requirements and collaborates with other members of the healthcare team to ensure patient safety.
• Provides patient education regarding required study procedures.
• Educates and evaluates patients' adherence to and documentation of self-administered protocol agents, diaries, and return of such agents.
• Collaborates with the investigator to determine if any treatment schedule or drug dose modification is necessary and communicates findings to the study team and other care providers.
• Ensures appropriate communication between research and clinical staff related to patient-specific care needs.
• Ensures evidence-based symptom management as permitted by the protocol.
• Administers investigational compounds and/or chemotherapy/biotherapy to patients according to the protocol and applicable regulations.
• Performs study-required procedures such as routine lab collection, study-specific sample collection, vital signs, and ECGs, according to the protocol-defined timeline.
• Records all study procedures performed, including vital signs, ECGs, blood draws, infusions, and infusion reactions.

Required Education and Experience

• Current BLS and ACLS or obtained within 90 days of employment.
• Current Registered Nursing License in the state the role is based in for RNs.
• OCN preferred.
• IV and venous access device management skills.
• Chemotherapy/Biotherapy administration experience.

The potential base pay range for this role, when annualized, is $54,500.00 - $136,100.00.

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