Cancer Clinical Research Quality Monitor Jobs

Obtains informed consent under minimal supervision of the investigator(s) 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.

Assists in preparing grant applications, IRB/GCO for submission and filings.

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

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.

1-2 years of research experience

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.

Preferred Education, Experience and Skills:

SOCRA/ACRP (or equivalent) certification; Master’s Degree or other advanced degree in related field.

YCCI Clinical Research Associate (Monitor)

None - Not included in the union (Yale Union Group)

Click here to see our Wage Ranges

Total # of hours to be worked:

Reviews goals and requirements of any new protocols; plans and designs source documentation for protocol; and coordinates study initiation.

Three (3) years of nursing experience in the designated study area is required.

Screens, recruits and consents study participants.

Instructs and counsels patients in research procedures, to include administration, monitoring, recording and analyzing data.

Ensures compliance with all federal and local regulations.

Monitors close-out of studies and ensures records are retained for appropriate length of time.

Work Location: Remote (within Texas only)

Minimum Salary: US Dollar (USD) 54,500

Midpoint Salary: US Dollar (USD) 68,000

Maximum Salary : US Dollar (USD) 81,500

FLSA: exempt and not eligible for overtime pay

Preferred Skills- Previous Lab Management experience

Requires a working knowledge of statistics, computer programming and research methodologies.

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

in the state and also provides education and training for other health professionals including nurses,

Whether it's offering a new medical option, helping you make healthier lifestyle choices or

making the employee enrollment selection experience easier, it's all about choice. Henry

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

in the state and also provides education and training for other health professionals including nurses,

Whether it's offering a new medical option, helping you make healthier lifestyle choices or

making the employee enrollment selection experience easier, it's all about choice. Henry

Ford Health has a new approach for its employee benefits program - My Choice

dozens of options for all of our employees including compensation, benefits, work/life balance

Perform remote and on-site monitoring & oversight activities in accordance with protocol, GCP/ICH Guidelines, and AFT SOPs.

Manage on-site medication accountability and inventory throughout clinical study.

In conjunction with the AFT IHCRA, manage and maintain information and documentation in CTMS and eTMF.

Minimum two years clinical monitoring experience required, with a strong preference for oncology monitoring experience

Deep knowledge of monitoring procedures and entire clinical trial process

Excellent organizational, leadership, and problem-solving skills

Experience working in a clinical role in or around oncology and chemotherapy.

Experience performing or documenting clinical research

Must be licensed to practice as a Registered Nurse in the state of North Carolina or one of compact states.

Legal Employer: Pardee - HCHC

Entity: Pardee UNC Health Care

Exempt From Overtime: Exempt: No

At least 2 years of cancer research experience

Current and in-depth knowledge of pan-cancer: screening, early detection, biomarkers, diagnostic prediction, genetics, prevention, and chemical- and vaccine-therapeutics (practical and experimental)

Expert knowledge and understanding of worldwide pan-cancer drug development pipelines

Experience with protein, RNA, and small metabolite cancer biomarker analysis

Position title and compensation are commensurate with experience.

Contribute highly practical and readily translatable pan-cancer screening/early detection, diagnostic, prevention and therapeutic ideas

Additional experience with molecular biology techniques such as mammalian cell transfection and differentiation are strongly preferred

Ability to manage multiple projects, prioritize work and meet tight deadlines

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

Develop, optimize and validate cell-based assays to evaluate various mRNA therapeutics

Ensures accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates

Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians

Ensures query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements

Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations

Works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice

Up to 2 years of related experience

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

Clinical research in Oncology experience: 2 years, required

Minimum of 5+ years of previous Quality Assurance experience in clinical research, required.

Patient First – Keeping the patient at the center of everything we do

Accountability – Taking responsibility for our actions

Commitment & Care – Upholding FCS vision through every action

Team – Working together, one team, one mission

Demonstrated presentation and team facilitation skills

Excellent oral and written communication skills

Applying for this job indicates your acknowledgement and understanding of the following statements:

Coordinate and provide information to support quality improvement studies, initiatives and accreditation reviews.

Bachelor’s Degree in a health care or quality related field.

Ability to work independently with minimal supervision or function in a team environment sharing responsibility, roles and accountability.

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

Experience/expertise in multiple of the following:

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including:

Participates in required training and education programs. May be involved in training and education of other Clinical Research Associates.

1 year-Clinical Research Related Experience

SOCRA or ACRP certification, preferred

Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Completes Case Report Forms (CRFs).

Ph.D. in a biological science or M.S. with extensive relevant experience

Experience/expertise in multiple of the following:

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

Help identify and prioritize new target antigens and vaccine concepts to advance into discovery and through preclinical development