Senior Clinical Research Associate II, Functional Service Provider - Oncology.
Location
North Dakota + 18 moreAll locations: North Dakota | South Dakota | Nebraska | Kansas | Oklahoma | Texas | Minnesota | Iowa | Missouri | Arkansas | Louisiana | Wisconsin | Illinois | Kentucky | Mississippi | Alabama | Michigan | Indiana | Ohio
Posted
4 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Research Associate II, Functional Service Provider - Oncology.
Fortrea
Title: Sr. CRA 2, FSP - Oncology Location: Central & MidwestUnited States Work Type: Remote, Full Time Job ID: 262398 Job Description: Our FSP team is currently seeking a Sr. CRA 2 with 4+ years of monitoring as well as strong Oncology monitoring experience residing in the Central and Mid-West US. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: - Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - - Responsible for all aspects of site management as prescribed in the project plans - General On-Site Monitoring - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study - Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements - Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data - Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested - Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs - Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management - Assist with training of new employees, eg. co-monitoring - Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned - Perform other duties as assigned by management Requirements - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) - 4+ years of Clinical Monitoring experience - Oncology experience is required - 60-70% overnight travel The important thing for us is you are comfortable working in an environment that is: - Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. - Changing priorities constantly asking you to prioritize and adapt on the spot. - Teamwork and people skills are essential for the study to run smoothly. - Technology based. We collect our data directly into an electronic environment. Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. - Target Pay Range: $115 - $140K #LI - Remote
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Clinical Secretary
Yale UniversityYale University is a prestigious, private, Ivy League research institution with roots dating back to the 17th century. Officially founded as Yale College in 171
Provide high-level administrative support by managing incoming calls, scheduling patient appointments, maintaining accurate patient records, and ensuring prompt service to patients and referring providers within a clinical environment.
Clinical Dietitian
Compass GroupFounded in 1941, Compass Group is a multinational corporation and the world’s largest provider of contract foodservice and support services. Headquartered in
Provide comprehensive nutritional assessments and develop individualized care plans to enhance patient recovery. Collaborate with interdisciplinary teams to deliver education on nutrition strategies and contribute to quality improvement initiatives in...
Senior Clinical Trial Manager – Tagalog Proficient
Syneos HealthSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. We are continuously building the company we all want to work for and our customers want to work with.
• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversees site interactions post activation through site closeout • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT) • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations • Participates and presents in key meetings such as Kick Off Meeting • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines • Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed • Ensures access and audit trail reviews are conducted as required • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan • Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity • Document requested revisions and approvals in CTMS • Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements • Provides solutions for obstacles in protocol execution and site management • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations • Supports Inspection Readiness for clinical trial management scope • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks • May develop and support execution of corrective action plans at site and study level • Supports and completes activities to achieve data cut and lock deadlines • Provides feedback to line managers on staff performance including strengths as well as areas for development • May be assigned to larger,more complex trials.
Clinical Dietitian
Compass GroupFounded in 1941, Compass Group is a multinational corporation and the world’s largest provider of contract foodservice and support services. Headquartered in
Title: CLINICAL DIETITIAN - HRLY Location: Sierra Vista & Twin Cities United States Job Type: Part Time Job Description: Morrison Healthcare - We are hiring immediately for a PRN Clinical Dietitian position. - Location: Morrison Healthcare with Adventist Health; offering coverage between both Sierra Vista & Twin Cities Hospital - Schedule: 8-24 hrs/week, availability to work holidays and weekends. - Requirement: Must be registered by the Commission on Dietetic Registration or eligible. - Additional Perks: Complimentary meals offered during your shift - Pay Range: $40/hr- $54/hr Make a difference in the lives of people, your community, and yourself. At Morrison Healthcare, a Compass Healthcare company, you'll join a culture that values caring for people, fostering belonging, and creating moments that truly matter. Here, your work has purpose: to nourish patients, caregivers, and communities while upholding the highest standards of detail, quality, and excellence in every meal served. For more than 70 years, Morrison has supported leading health systems nationwide with culinary, nutritional, and operational expertise. With more than 31,000 dedicated team members, including 1,600 registered dietitians and 1,200 executive chefs, we empower and uplift each other by working together, take responsibility for our commitments, and believe in helping one another achieve more together by realizing our unlimited potential. Job Summary Make a real impact as a Clinical Dietitian! You'll provide Medical Nutrition Therapy and education in an acute care setting, working with a collaborative team to enhance patient outcomes through evidence-based nutrition care. What You'll Do: - Clinical Nutrition Care: Perform comprehensive nutritional assessments and develop individualized care plans to promote recovery and improve health outcomes - Education: Provide guidance on nutrition and lifestyle strategies to support sustainable, long-term wellness to patients, families, staff, and the community - Evidence-Based Practice: Apply the latest research in alignment with the diet manual, company policies, and facility protocols to ensure high-quality, consistent care - Quality & Performance Improvement: Contribute to QAPI initiatives aimed at advancing patient care and clinical excellence - Collaboration & Service Excellence: Partner with the food service management team to help achieve patient satisfaction and service goals - Mentorship & Professional Development: Support the growth of staff and dietetic interns through education and training as applicable What We're Looking For: - Registered Dietitian Nutritionist (RDN) or CDR exam eligible - Licensed Dietitian (or willing to obtain) in the state of practice as applicable - Healthcare experience preferred-new graduates with strong clinical training are encouraged to apply Why You'll Love Working Here: - You'll be part of an environment where your ideas are welcomed, and your growth is encouraged - You'll have access to ongoing education, resources, development, and advancement opportunities to support your career path - You'll have the autonomy to apply your clinical judgment while still having guidance when you need it BENEFITS FOR OUR TEAM MEMBERS - Full-time and part-time positions are offered the following benefits: Retirement Plan, Associate Shopping Program, Health and Wellness Programs, Discount Marketplace, Identify Theft Protection, Pet Insurance, and other voluntary benefits including Critical Illness Insurance, Accident Insurance, Hospital Indemnity Insurance, Legal Services, and Choice Auto and Home Program - Full-time positions also offer the following benefits to associates: Medical, Dental, Vision, Life Insurance/AD, Disability Insurance, Commuter Benefits, Employee Assistance Program, Flexible Spending Accounts (FSAs) Morrison Healthcare is a member of Compass Group. Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity.


