Clinical research monitor job description

The Clinical Trials Monitor helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the Dana-Farber Cancer Institute and Dana-Farber Harvard Cancer Center (DF/HCC) consortium. Under the direction of Clinical Trials Office Leadership, this position will assist in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols. The Clinical Trials Monitor will ensure that, for those clinical trials assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards. Monitoring will be performed through a combination of remote data review and onsite monitoring visits; therefore, a willingness and ability to travel occasionally is required. The Clinical Trials Monitor is responsible for multiple projects at a time, and must have strong time management skills in addition to working both independently and in a team environment. This position will be responsible for promoting a culture of monitoring compliance and regulatory awareness within DFCI and DF/HCC.

This position is 4-5 days remote. Only applicants living in the New England states at the time of employment will be considered. Candidates must have the ability to work from our Boston, MA office for onsite days.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Ensure the Sponsor-Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI CTO Monitoring standards and guidelines.

Adhere to the protocols' Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.

Monitor clinical trial progress through a combination of remote data review and on site monitoring visits. Some travel will be required.

Verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).

Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
Assist in the development and writing of clinical trial monitoring plans. Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation. Participate in regular monitoring team group meetings.
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Bachelor's degree in a field relevant to research compliance 3+ years of progressively responsible clinical trials experience with 1+ years of monitoring experience. Experience in an academic institution is preferred, especially working in collaborative efforts with upper administrators, faculty and research staff as well as research support personnel. Must have expertise in research ethics and the responsible conduct of research.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

You could be the one who changes everything for our 26 million members as a clinical professional on our Medical Management/Health Services team. Centene is a diversified, national organization offering competitive benefits including a fresh perspective on workplace flexibility.

Position Purpose: Responsible for clinical file assessments for Care Management (inclusive of BH and UM). Identifies monthly insights for improvement and participates in Interrater Reliability meetings. Aids in efforts to continuously develop review tools to ensure validity of criteria, and appropriately captures evidence of expected clinical performance within contractual and Model of Care standards.
***Position is REMOTE***

* Conducts Care Management (UM, BH, CM) clinical file assessments by reviewing clinical documentation as assigned for Care Management for required clinical adherence.

* Participates in the development and ongoing review of clinical review tool to ensure that clinical elements accurately capture adherence with required performance standards.

* Reviews Care Management program descriptions, policies and procedures, step actions, and training materials as well as State Contracts when needed to evaluate alignment of review tool elements, departmental processes, staff training, and contractual/departmental standards.

* Utilizes clinical knowledge and experience to evaluate documentation of member health assessments, clinical needs and interventions in meeting compliance standards.

* Participates in meetings with Care Management and others to discuss review findings, areas of opportunity and recommendations for improvement.

* Appropriately escalates areas of concern identified during clinical file reviews.

* Participates as needed with preparation for State, CMS, and NCQA audits by collecting and /or reviewing clinical areas of relevance.

* Meets established productivity and IRR standards for file reviews.

* Follows departmental guidelines and processes.

* Other duties as assigned. Additional Responsibilities:

Education/Experience: Bachelor's Degree in Nursing, Clinical Social Work/Counseling required OR Associate's degree and an RN with 3+ years of clinical experience. 3+ years of experience in a clinical environment (inpatient or outpatient). 1+ year of experience in Managed Care (UM, BH, CM) preferred. Familiarity with Medicare and Medicaid programs preferred.

Licenses and Certifications: A license in one of the following is required: Licensed Registered Nurse (RN), Licensed Clinical Social Worker (LCSW), Licensed Mental Health Counselor (LMHC), or Licensed Marital and Family Therapist (LMFT). Certified Case Manager (CCM) preferred.

Our Comprehensive Benefits Package: Flexible work solutions including remote options, hybrid work schedules and dress flexibility, Competitive pay, Paid time off including holidays, Health insurance coverage for you and your dependents, 401(k) and stock purchase plans, Tuition reimbursement and best-in-class training and development.

Centene is an equal opportunity employer that is committed to diversity, and values the ways in which we are different. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristic protected by applicable law.

**TITLE:** Performance Monitor Specialist, Clinic (RN)

**LOCATION:** Various, Missouri

**REQNUMBER:** 1355005

There's a reason St. Jude Children's Research Hospital is consistently ranked on Fortune Magazine's "100 Best Places to Work For" list. At our world-class pediatric research hospital, every one of our professionals shares our commitment to make a difference in the lives of the children we serve. There's a unique bond when you are part of a team that gives their all to advance the treatments and cures of pediatric catastrophic diseases. The result is a collaborative, positive environment where everyone, regardless of their role, receives the resources, support, and encouragement to advance and grow their careers and be the force behind the cures.
Responsibilities

The Clinical Research Monitor will be responsible for:

* Monitoring the protocol and regulatory compliance of clinical research studies, in multiple treatment areas, conducted across numerous departments in accordance with the specific protocol documents and federal regulations.
* Examining the accuracy, completeness, and timeliness of research data which has been abstracted from source documentation and entered into the Electronic Data Capture (EDC) system.
* Writing detailed monitoring reports for assigned studies. Determines data to be monitored for assigned protocols utilizing the Institutional Data and Safety Monitoring plan, working with general supervision as needed.
* Can assist with development of documents and implementation of study-specific monitoring plans based on Institutional Data and Safety Monitoring Plan, with general supervision as needed
* Coordinates study team activities for the monitoring of studies
* Providing support to other Clinical Research Monitoring personnel within Clinical Trials Operations (CTO).
* Supporting the project manager (PM) and Manager, Trial Monitoring in communicating with study teams regarding trial qualification, initiation, monitoring, remote monitoring and close-out activities.
* Responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts.

Minimum Education

* Bachelor's Degree in a scientific or health-care related area required
* RN preferred

Minimum Experience

* Four (4) years of clinical research experience required with one year of monitoring experience preferred, otherwise three (3) years of monitoring experience required; will consider Associates Degree with 5 years of monitoring experience in lieu of Bachelor's Degree
* Oncology experience required

Required Credentials

* Ability to travel at least 50%

Other Credentials

* (LC:SoCRA or ACRP) SoCRA or ACRP certification required within two (2) years of hire into position

Other Information

St. Jude is an Equal Opportunity Employer

No Search Firms:

St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.

COVID-19 vaccine:

St. Jude Children's Research Hospital has mandated the COVID-19 vaccine for all employees, excluding those with an approved medical or religious accommodation, as a condition of employment.