Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

FSP Clinical Trial Coordinator II

Location

United States

Posted

69 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

FSP Clinical Trial Coordinator II

Thermo Fisher Scientific

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coordinator II, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements. This is a fully remote for candidates located in the United States. Candidates located in Eastern Standard Time preferred, or flexibility working within EST. What You’ll Do: • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate. • Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system. • Provides system support (i.e. GoBalto & eTMF). • Supports RBM activities. • Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. • Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes. • Reviews and tracks local regulatory documents. • Transmits documents to client and centralized IRB/IEC. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • Maintains vendor trackers. • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. • Assists with study-specific translation materials and translation QC upon request. • May attend Kick off meeting and take notes when required. Education and Experience Requirements: • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. • Bachelor's degree preferred with education in medical or biological sciences or discipline associated with clinical research preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Ability to work in a team or independently as required • Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete PPD clinical training program • Self-motivated, positive attitude with effective strong interpersonal skills Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment. • Occasional drives to site locations. Potential Occasional travel required

Related Categories

Related Job Pages

More Clinical Research Jobs

Centene Corporation logo

Clinical Review Nurse - Prior Authorization

Centene Corporation

Transforming the health of the communities we serve, one person at a time.

Full TimeRemoteTeam 10,001+Since 1984H1B No Sponsor

You could be the one who changes everything for our 28 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. Work Location This is a fully remote role. Candidates must hold active New York State Registered Nurse (RN) licensure and be willing to work Eastern Time (ET/EST) hours. Licensure Requirement Active and unrestricted New York State Registered Nurse (RN) licensure is required for consideration. Schedule This position follows a Monday–Friday schedule from 8:30 AM to 5:00 PM Eastern Time (ET/EST), with a one‑hour assigned lunch break. Candidates must be able to work during these hours. Position Purpose: Analyzes all prior authorization requests to determine medical necessity of service and appropriate level of care in accordance with national standards, contractual requirements, and a member's benefit coverage. Provides recommendations to the appropriate medical team to promote quality and cost effectiveness of medical care. - Performs medical necessity and clinical reviews of authorization requests to determine medical appropriateness of care in accordance with regulatory guidelines and criteria - Works with healthcare providers and authorization team to ensure timely review of services and/or requests to ensure members receive authorized care - Coordinates as appropriate with healthcare providers and interdepartmental teams, to assess medical necessity of care of member - Escalates prior authorization requests to Medical Directors as appropriate to determine appropriateness of care - Assists with service authorization requests for a member’s transfer or discharge plans to ensure a timely discharge between levels of care and facilities - Collects, documents, and maintains all member’s clinical information in health management systems to ensure compliance with regulatory guidelines - Assists with providing education to providers and/or interdepartmental teams on utilization processes to promote high quality and cost-effective medical care to members - Provides feedback on opportunities to improve the authorization review process for members - Performs other duties as assigned - Complies with all policies and standards Education/Experience: Requires Graduate from an Accredited School of Nursing or Bachelor’s degree in Nursing and 2 – 4 years of related experience. - Clinical knowledge and ability to analyze authorization requests and determine medical necessity of service preferred. - Knowledge of Medicare and Medicaid regulations preferred. - Knowledge of utilization management processes preferred. License/Certification: - LPN - Licensed Practical Nurse - State Licensure required - This position is aligned to support Fidelis Care. NYS RN Licensure required. Pay Range: $27.02 - $48.55 per hour Centene offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors permitted by law, including full-time or part-time status. Total compensation may also include additional forms of incentives. Benefits may be subject to program eligibility. 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. Qualified applicants with arrest or conviction records will be considered in accordance with the LA County Ordinance and the California Fair Chance Act

United States
$27 - $49 / hour
Centene Corporation logo

Clinical Review Nurse - Concurrent Review

Centene Corporation

Transforming the health of the communities we serve, one person at a time.

Full TimeRemoteTeam 10,001+Since 1984H1B No Sponsor

You could be the one who changes everything for our 28 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. This is a fully remote position. Candidates must hold an active New York State (NYS) RN licensure to be considered. The standard work schedule is Monday through Friday, 8:30 a.m. to 5:00 p.m. EST, with the potential for weekend coverage based on business needs. Position Purpose: Performs concurrent reviews, including determining member's overall health, reviewing the type of care being delivered, evaluating medical necessity, and contributing to discharge planning according to care policies and guidelines. Assists evaluating inpatient services to validate the necessity and setting of care being delivered to the member. - Performs concurrent reviews of member for appropriate care and setting to determine overall health and appropriate level of care - Reviews quality and continuity of care by reviewing acuity level, resource consumption, length of stay, and discharge planning of member - Works with Medical Affairs and/or Medical Directors as needed to discuss member care being delivered - Collects, documents, and maintains concurrent review findings, discharge plans, and actions taken on member medical records in health management systems according to utilization management policies and guidelines - Works with healthcare providers to approve medical determinations or provide recommendations based on requested services and concurrent review findings - Assists with providing education to providers on utilization processes to ensure high quality appropriate care to members - Provides feedback to leadership on opportunities to improve appropriate level of care and medically necessity based on clinical policies and guidelines - Reviews member’s transfer or discharge plans to ensure a timely discharge between levels of care and facilities - Collaborates with care management on referral of members as appropriate - Performs other duties as assigned. - Complies with all policies and standards. Education/Experience: Requires Graduate from an Accredited School of Nursing or Bachelor’s degree in Nursing and 2 – 4 years of related experience. 2+ years of acute care experience required. - Clinical knowledge and ability to determine overall health of member including treatment needs and appropriate level of care preferred. - Knowledge of Medicare and Medicaid regulations preferred. - Knowledge of utilization management processes preferred. License/Certification: - LPN - Licensed Practical Nurse - State Licensure required - This position is aligned to support Fidelis Care. NYS RN licensure required. Pay Range: $27.02 - $48.55 per hour Centene offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors permitted by law, including full-time or part-time status. Total compensation may also include additional forms of incentives. Benefits may be subject to program eligibility. 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. Qualified applicants with arrest or conviction records will be considered in accordance with the LA County Ordinance and the California Fair Chance Act

United States
$27 - $49 / hour
SmarterDx logo

Clinical Specialist

SmarterDx

Capture new revenue. Represent care quality. Appeal every denial.

Full TimeRemoteTeam 201-500Since 2020H1B No Sponsor

SmarterDx, a Smarter Technologies company, builds clinical AI that is transforming how hospitals translate care into payment. Founded by physicians in 2020, our platform connects clinical context with revenue intelligence, helping health systems recover millions in missed revenue, improve quality scores, and appeal every denial. Become a Smartian and help optimize the way the healthcare system works for everyone. Learn more at smarterdx.com/careers. Clinical Product Specialist (SmarterNotes) Role The Clinical Specialist (CS) sits at the intersection of clinical medicine, AI, and product development, playing a critical role in building SmarterDx’s clinical documentation capabilities. As part of a highly cross-functional team spanning Product, Engineering, and Data Science, the CPS translates real-world physician workflows into scalable AI systems—shaping how clinical reasoning is represented, evaluated, and deployed in practice. This role has a direct impact on product quality and clinical trust. The CS defines and enforces the standard for clinical accuracy, safety, and usability, ensuring that what we build works for real clinicians in real care settings. For candidates interested in applying clinical expertise beyond the bedside, this is an opportunity to influence how AI supports documentation, decision-making, and ultimately patient care at scale. **This role is fully remote within the US** What You’ll Do - Serve as the clinical subject matter expert for clinical documentation, charting workflows, and end-to-end care delivery processes - Review AI-generated outputs (summaries, notes, insights) for accuracy, completeness, and clinical defensibility - Define and operationalize clinical quality standards for models output - Apply clinical judgment in ambiguous scenarios where documentation quality, trajectory, and context matter - Collaborate with Product and Data Science to build and refine prompts, pipelines, and model behavior What You Bring - NP or PA (or equivalent advanced clinical degree) - Clinical background with experience in inpatient or acute care settings - Strong understanding of clinical documentation and EHR workflows - Demonstrated ability to translate clinical thinking into structured systems, logic, or processes - Builder mindset with comfort working on ambiguous, evolving products - Strong analytical thinking with attention to edge cases and failure modes - Ability to collaborate effectively with Product, Engineering, and Data Science teams Nice To Haves - Familiarity with AI/ML systems or prompt engineering (preferred) - Background in clinical informatics, quality improvement, or workflow design - Experience working with Product, Engineering, or Data Science teams - Experience building or scaling systems (e.g., evaluation frameworks, workflows, or tools) - Previous advising or consulting experience with healthcare technology companies Compensation - $120k-$150k base + benefits #LI-Remote #LI-DNP Benefits - Medical, Dental & Vision – Comprehensive plans with leading insurance providers, covering 75% of your premiums, depending on the plan. - Paid Parental Leave – Generous paid leave to support families through birth or adoption: Up to 12 weeks for parents. - Remote-First Team – Work from anywhere in the U.S. - Unlimited PTO & 10 Holidays – So you can relax and recharge. - 401(k) with Traditional & Roth Options – Tax-advantaged retirement savings through Fidelity with a 4% match. - Minimal Bureaucracy – A fast-moving, high-impact environment where you can focus on what matters. - Incredible Teammates! – Work alongside smart, supportive, and mission-driven colleagues.

United States
$120K - $150K / year
Full TimeRemoteTeam 10,001+Since 1949H1B Sponsor

We anticipate the application window for this opening will close on - 21 Apr 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role. Provides sales field support to customers. Conducts on-site education and consulting, and supports establishment and maintenance of customer relations with healthcare professionals and patients MAIN JOB DUTIES/RESPONSIBILITIES - Support sales team with the implementation of clinical trials, research and data collection activities, - In conjunction with field sales and corporate teams, will identify, create, prioritize, and pursue opportunities and patient awareness campaigns across the region. - Provide technical, educational, operational and sales support to assist the district in meeting sales and customer service objectives - Provides on-call support and troubleshooting support as needed - Assures completion of patient registration and any other required hospital documentation - Helps manage consignment inventory and trunk inventory once obtained - Helps manage inventory support to meet customer needs - Assists with managing daily coverage logistics as needed - Educates and trains physicians, hospital personnel and office staff on products or solutions for which training has been completed - Partners with DSM, Sales Reps and DM to learn market dynamics and local customer motivations and needs; has a basic understanding of how Medtronic CRHF products and solutions offer value to the customer - Assists with obtaining customer POs throughout the quarter - Independently identifies customer needs and opportunities and provides feedback to Sales Rep(s) to support sales objectives SUMMARY OF REQUIREMENTS Minimum Requirements: - High School Diploma and a minimum 4 years of work experience in healthcare, field sales or work experience utilizing complex mathematics, mechanical concepts, science or computing - OR- - Associate degree and a minimum 2 years of work experience in the healthcare, field sales or work experience utilizing complex mathematics, mechanical concepts, science or computing - OR- - Bachelor’s Degree Preferred Qualifications: Relevant industry, healthcare, industry, marketing, or medical education experience considered where there is specific focus on awareness and education or medical project management. Demonstrated success in previous sales roles; indicating a high level of sales performance and/or successfully executed awareness and education programs. Expertise with Microsoft Outlook, Excel, Word and PowerPoint and system tracking. Strong project management skills and experience coordinating and executing marketing programs. Excellent interpersonal, written and verbal communication skills. Strong work ethic Thorough working knowledge of medical terminology, medical procedures and the medical device industry. Excellent customer service skills and problem resolution skills. Ability to effectively build and maintain positive relationships with peers and colleagues across organizational levels. MS Office; Word, Excel, Outlook Ability to travel 70% of the time. This position is field-based and regional. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$63000 - $79000 In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

North Carolina + 1 moreAll locations: North Carolina | Spain
$63K - $79K / year