Cancer Clinical Research Quality Monitor Jobs

Experience working in a similar support role in a complex organisation as an effective team member.

Salary Packaging – up to $9k for living expenses + $2.6k meal & entertainment + Novated leasing

Corporate Health and Fitness program

11% Superannuation on top of your gross income

Ability to make good decisions about work priorities and achieve key tasks effectively in a busy work area.

Understanding of, and commitment to, providing an excellent customer service and maintaining patient privacy and confidentiality.

We offer you an excellent total compensation package, including a competitive salary, comprehensive benefits, and growth opportunities

Ensures all staff have adequate training and certifications to treat patients in clinical trials

403b Retirement Plan with Employer Contributions

Employee Recognition Programs, Employee Discounts, and Employee Referral Bonus Program

On-site daycare exclusive to our employees’ children of all ages

Employer Paid Employee Wellness Center Membership with fitness classes, personal training, indoor pool, racquetball, and basketball courts

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Good problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Technical writing skills (protocols, CRF development, study tools)

Good computer skills in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery

Experience with electronic data capture preferred

Analyzes protocol specific requirements and implements quality assurance measures to ensure physician, patient, and clinician compliance.

Three (3) years of related experience required.

Organizational, analytical, and problem-solving skills required.

Demonstrated verbal and written skills at professional level required.

CERTIFICATIONS/LICENSURES REQUIRED: SOCRA or ACRP certification required.

education and training, the health system has trained nearly 40% of physicians currently practicing

3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required

Experience working in a medical device or regulated industry, preferred

Experience with electronic data capture, preferred

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Demonstrated problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Knowledge Skills And Abilities/License Or Certification Required

KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION

Demonstrated knowledge and experience with video conferencing products such as Zoom.

Three (3) years of recent oncology nursing experience

Evidence of nursing leadership experience.

Demonstrated knowledge of current NCCN guidelines and current cancer staging schema from the American Joint Commission on Cancer (AJCC)

Responsibilities include, but are not limited to:

Study Cohort Identification, Recruitment, and Consent:

Study Collection Biospecimen Documentation and Training:

Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs

Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Conducts site qualification, initiation, interim, and close-out visits

Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol

Travels to clinical study sites as required, including remote or onsite visits globally

Analytical problem-solving experience, trouble shooting and resourcefulness

3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required

Experience working in a medical device or regulated industry, preferred

Experience with electronic data capture, preferred

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Demonstrated problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Create and maintain accurate and reliable data in the OnCore Clinical Trials Management System

Work in conjunction with internal departments to ensure regulatory and statutory requirements are implemented in pre-PRMS processes within mandated timeframes

Organize and manage bimonthly regular meeting using Zoom and electronic voting

Manage and guide the DFG Coordinator as needed in daily operations

7 years experience in a hospital/medical environment

Experience in clinical research, preferably in cancer.

Assists with coordination and management of clinical trials including communication with Sponsors.

Under direct supervision of the Principle Investigator(s), obtains informed consent and educates participants regarding study requirements.

0-2 years of experience in a hospital or academic (research) environment preferred.

Excellent written and oral communication skills

Collects and records study data; inputs all information into database.

Secures, delivers and ships clinical specimens as required by the protocol.

Minimum 1 year of clinical research experience or medical research data management experience.

Bachelor’s degree or an equivalent combination of education and experience.

Assists in the design, development, execution and administration of data entry for protocols and clinical studies.

Follows study participants; manages collection of data including maintaining records of patient visits/interviews.

Excellent verbal, written and interpersonal communication skills.

Ability to manage complex information with attention to detail and a high level of accuracy

3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required

Experience working in a medical device or regulated industry, preferred

Experience with electronic data capture, preferred

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Demonstrated problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Maintains leadership competency by participation in continuing education, professional organizations and other related activities.

Supports academic affiliations for purposes of providing clinically enriching experiences for students of nursing and other related clinical disciplines.

Promotes an interdisciplinary approach to patient care delivery.

Serves as a resource for patients and their families.

Acts as a patient advocate utilizing the Patient Bill of Rights.

Participates in promoting and maintaining a safe and therapeutic environment.

Ph.D. degree with 3+ years of experience in molecular biology, cancer biology, bioengineering, biophysics, or related discipline.

Experience with mammalian cell culture

Innovative and analytical thinker with strong interpersonal and communication skills

Experience with CRISPR screening, NGS-based assays

Experience with analysis of large-scale datasets

Experience with assay development and troubleshooting

Bachelor’s degree or an equivalent combination of education and experience

6 to 12 months experience in a research or health care setting

Excellent verbal, written and interpersonal communication skills

Ability to manage complex information with attention to detail and a high level of accuracy

Relevant experience in the conduct of clinical or laboratory research studies

Knowledge of regulatory guidelines and procedures

Represent the project in relevant teams and the protocol review committee and review and comment the Investigator’s brochure.

Balancing the duties of a physician with that of an administrator.

Ensuring that patients receive the highest standard of medical care.

Being responsible for the performance of physicians under your supervision.

Ensuring that all healthcare regulations and safety standards are met.

Keeping staff updated on new healthcare regulations.

Effective time management with the ability to perform in a fast-paced environment where deadlines are a factor.

Education & Work Experience Required

Excellent listening, verbal, written and interpersonal communication skills.

Strong attention to detail, follow-up skills, and consistency.

Excellent data collection and analysis skills.

Proficient knowledge of Microsoft Office applications.

Experience and knowledge in handling, maintaining and analyzing transgenic and/or knockout mouse models of human diseases.

A minimum of three years related research experience.

Possesses and applies comprehensive knowledge of research principles, concepts, practices and methods.

Be able to follow, refine, and improve the experimental procedures required for completion of the assigned experiments and aims.

Ensure compliance with regulations and make records of observations and scientific measurement.

Perform complex data collection and laboratory techniques, evaluation and analysis requiring use of independent judgment.

Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.

Knowledge, Skills And Abilities (required)

Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.

Knowledge of the principles of clinical research and federal regulations.

Previous experience with clinical research.

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.