Art of the possible.
Clinical Research Monitor
Location
Maryland
Posted
73 days ago
Salary
$74.0K - $86.3K / year
Seniority
Senior
Job Description
Clinical Research Monitor
General Dynamics Information Technology
Title: Clinical Research Monitor Location: USA MD Fort Detrick - Fort Detrick (MDC001) Job Description: Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: NACI (T1) Job Family: Ancillary Health Job Qualifications: Skills: Clinical Research, Data Compilation, Research Protocols Certifications: None Experience: 4 + years of related experience US Citizenship Required: Yes Job Description: GDIT's Military Health team is hiring a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoW located at Ft. Detrick in Frederick, Maryland. The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring. ORA operates in a high-paced environment and seeks individuals who can work independently and take initiative in completing tasks. The CRA will provide clinical trial monitoring to ensure all sponsor required trial monitoring is conducted and all deliverables are provided according to 21 CFR 312 and ICH. ***This is a hybrid position and will report onsite 2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance. Must be able to travel CONUS and OCONUS (potentially working on emergency use products). HOW YOU WILL MAKE AN IMPACT: - Develop a Clinical Monitoring Plan and monitor single site and multicenter clinical studies both inside and outside the continental United States; when required, conduct centralized monitoring activities. - Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file. The monitoring reports shall include the date of activities, description of the activities, and any findings from the activities-Prepare protocol deviations and violation and non-compliance reports - Provide remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted and annotate in monitoring reports for the sponsor’s regulatory file. - Prepare/review calibration and maintenance records, which are records kept at the clinical site that document the calibration and maintenance of all applicable equipment utilized during the execution of the clinical trial including laboratory equipment, and ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file. - Prepare and/or review shipment records, which include shipping documentation for investigation products, biological samples, and if applicable, other study supplies provided to the clinical sites. - Prepare and/or review laboratory sample analysis reports WHAT YOU’LL NEED TO SUCCEED: - Bachelors degree, 4+ year’s experience supporting clinical research - Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file. - Experience providing remote evaluation of the study data - Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file. - Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites. - ORA operates in a high-paced environment and seeks individuals who can work independently and take initiative in completing tasks. - Must be a US Citizen with the ability to obtain a favorable NACLI T1 security investigation prior to start date. - TRAVEL: Must be able to travel CONUS and OCONUS (working on emergency use products) WHAT GDIT CAN OFFER YOU: - Challenging work that makes a real impact on the world around you - Internal mobility team dedicated to helping you own your career - 401K with company match - Diverse, highly collaborative teams - Professional development, education assistance, certification and training opportunities #GDITHealth #militaryhealth #GDITLabScienceJobs #GDITFedHealthJobs #GDITPriority The likely salary range for this position is $73,965 - $86,250. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Scheduled Weekly Hours: 40 Travel Required: 10-25% Telecommuting Options: Hybrid Work Location: USA MD Fort Detrick Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most. We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology. Join our Talent Community to stay up to date on our career opportunities and events at gdit.com/tc. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
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Clinical Supervisor - OT
ExpressableCommitted to improving speech and language outcomes for children and adults with affordable, online therapy.
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This position is highly dedicated to increasing and maintaining clinical excellence, while prioritizing bidirectional communication to ensure organizational priorities are successfully implemented. 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Clinical Trial Liaison, Sponsor Dedicated
ICON plcICON plc, or simply ICON, is a global provider of outsourced development services to companies in industries like biotechnology, medical devices, and pharmaceut
Clinical Trial Liaison, Sponsor Dedicated ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development As a Clinical Trial Liaison at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. What You Will Do: Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders. Key responsibilities include: - Collaborate with cross-functional teams to design and implement effective clinical trial enrollment strategies. - Analyze and interpret clinical trial data, ensuring accuracy and compliance with regulatory standards. - Foster strong relationships with study sites and investigators to enhance patient recruitment and retention. - Act as a liaison between sponsors, investigators, and study participants, providing support and guidance throughout the enrollment process. - Contribute to the continuous improvement of enrollment processes and strategies to optimize trial outcomes. Your Profile: You will bring relevant clinical research experience, along with the following qualifications and skills. Required qualifications and experience: - Bachelor's degree in a relevant field, such as life sciences or healthcare. - Oncology experience is required - Proven experience in clinical trial enrollment or related roles. - Strong analytical and problem-solving skills with the ability to interpret complex medical data. - Excellent communication and interpersonal skills to build and maintain effective relationships with stakeholders. - Detail-oriented with a commitment to ensuring accuracy and compliance in all aspects of clinical trial enrollment. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
Associate Decentralized Clinical Trial Study Lead (aDCTL) / Decentralized Clinical Trial Lead (DCTL) are an integral part of clinical trial delivery to improve patients’ lives and bring therapies to the market faster. The aDCTL / DCTL roles requires strong project management skills, customer and site facing engagement experience, creativity/innovation and the ability to thrive in a dynamic setting. The aDCTL / DCTL may oversee studies ranging from fully decentralized trials to hybrid studies which require liaising with traditional project delivery teams. Critical to the success of DCT is the ability to collaborate across multiple teams and stakeholders including but not limited to technology & IT , mobile nursing, site support services, regulatory, site startup, etc. aDCTL / DCTL’s also follow established SOP and policies focused on project delivery, productivity and quality resulting in strong project financial performance and customer satisfaction. Essential Functions • Accountable for the strategic development and delivery of DCT studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures. • Serve as DCT project oversight and/or contact with customers and own relationship with the project’s key customer contact(s) • Set objectives and manage for the DCT project team according to agreed upon contract, strategy and approach for operational delivery, effectively communicate and assess performance, providing feedback and leadership. • Collaborate with other functional groups within the company where necessary, including the core study team, to develop and/or support the preparation of integrated study management plans, support milestone achievement and manage study issues and obstacles. • Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally. • Supervise Foresee problem solving and resolution efforts to include management of risks, and manage contingencies and issues. Take accountability for proactive contingency plans to mitigate risks. • Achieve project quality by identifying and proactively managing quality risks and issues, responding to issues raised by project team members and /implementing appropriate corrective and preventative action plans. Take ownership, understand the budget and drive optimal project financial management from initial load to study closeout • Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability. • Actively work on preserving DCT scope and Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward and implement appropriate actions to achieve. • Identify changes in scope and manage change control process, including securing customer agreement to financial and milestone updates as necessary. • Identify and communicate lessons learned and best practices to promote continuous improvement. Other Functions May Include • Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for 100% Virtual studies or as a component of the larger team for integrated hybrid DCTs studies. Understand project strategy and operationalize the agreed upon approach. • Adopt corporate initiatives and changes and serve as a change advocate when necessary. • Provide input to line managers on their project team members’ performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development. • Educate and train other teams and partners on the processes, capabilities and structure of the DCT organization. • Communicate/collaborate with IQVIA business development representatives as necessary. • May participate in executive committees as part of program leadership. Qualifications • Bachelor's Degree Life sciences or related field • Requires +4 years relevant clinical research experience plus around 3 years of experience in project management experience. • Requires advanced knowledge of and experience implementing Project Management methodologies, ideally within the clinical research space. • Broad knowledge of DCT (current challenges and opportunities to improve clinical trial delivery) and other related job areas, typically obtained through advanced education combined with experience. • Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. • Technology Savvy – You have an affinity for learning and leveraging technology. Prior experience with set up or implementation of new platform/systems is a plus. • Communication - Strong written and verbal communication skills including good command of English language. Strong presentation, negotiation and customer management skills. • Finances - Good understanding of project financials including experience managing financials (budget), contractual obligations and implications. #LI-NRJ #LI-Remote IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
We anticipate the application window for this opening will close on - 17 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 Job Specific Summary 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. At Medtronic, the Clinical Specialist, supports the Neuromodulation Pain and Target Drug Delivery as well as Interventional Therapies (in some districts) in the areas of surgical coverage, follow-up support, troubleshooting, customer service and education. This person will be engaged in basic market development activities depending upon the needs of the assigned territory and district. This is a field based role. Responsibilities may include the following and other duties may be assigned: • Represents Medtronic during surgical procedures (trials, implants, revisions) by ensuring access to all necessary equipment and products required for the case, device selection, programming, implantation and testing of all device systems • Manages patients through all phases of the clinical process as well as educate them on the features and benefits of Medtronic products • Provides clinical support in surgeries, re-programmings, trouble-shooting and follow ups in hospitals and clinics • Responds promptly and appropriately to technical inquiries by customers, patients, and colleagues • Maintains a working knowledge of competitive products • Educates and trains physicians, hospital personnel and office staff on technical matters relating to our products and therapies - this is achieved by coordinating: one on one teaching sessions, formal in-service education programs, seminars and/or outside symposia • Assists Management and Sales Training department in education/training of new employees in the district • Complies with required event reporting and documentation utilizing Medtronic technology tools • Accountable to place an order with customer service for pending purchase orders and product replacement and is responsible for working with materials management to collect POs for cases covered within the territory/district • Responsible for managing inventory provided for case coverage, Including: timely transactions when product is used, sold or transferred, maintaining a required level of cycle count accuracy, executing product retrievals as instructed, turning over inventory in a reasonable time frame, not implanting expired product or product that is on hold • Contributes to the achievement of quarterly goals associated with specific initiatives at the district, regional and/or national level • Partners with sales representatives to achieve business goals set forth within the territory/district and documents quarterly activities utilizing provided business tool(s) • Visits accounts to replenish literature and establishes/maintains relationships with office staff • Mentors Associate Clinical Specialists • Ability to effectively use a mobile phone, IPAD and PC • Ability to manage personal expenses and budget effectively • Ensures personal understanding of all quality policy/system items that are personally applicable • Follows all work/quality procedures to ensure quality system compliance and high quality work We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader —that’s why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion & Diversity at Medtronic Click Here Qualifications Must Have: Minimum Requirements To be considered for this role, please ensure these minimum requirements are evident in your applicant profile. · A High School Diploma or GED with a minimum of 6 years of clinical or medical sales experience; or · An Associate’s Degree with a minimum of 4 years of clinical or medical sales experience; or · A Bachelor’s degree with a minimum of 2 years of clinical or medical sales experience. Nice to Have: Preferences · Bachelor's degree in a health care related field · Master’s degree · Registered nurse or HCP with experience in a sterile environment · Clinical experience with implantable neurological products and patient care · Experience in servicing medical personnel on product use · Experience with a medical device company or pharmaceutical company, and clinical experience in a specialty area: neurology, neurosurgery, orthopedic, operating room, pain management, or home health care · Understands basic reimbursement and healthcare environment · Excellent organizational skills and ability to work under pressure · Preference will be given to local qualified candidates and candidates with Medtronic experience Additional Job Requirements: • Required to function using healthcare universal precautions to minimize exposure to infectious disease and radiation • Ability to serve as the primary resource for scheduled and unscheduled clinical events, periodically required to work weekends, evenings and nights and may be required to engage in overnight travel within own district or neighboring districts • Ability to work efficiently and autonomously with little direction when outside of clinical events • Ability to attend national meetings, district meetings and other training as requested • Ability to wear a 7-9 lbs protective lead apron for extended periods of time in the operating room • Ability to lift up to 40 lbs • Ability to sitting, standing, and/or walking for 8+ hours per day • Ability to bend/stoop, squat and balance frequently • Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer. **Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application. Business Description: Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients. We're committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures and deliver successful patient outcomes. The Neuromodulation Operating Unit offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer, and severe spasticity. Our key Interventional Pain therapies include: Balloon Kyphoplasty, Vertebroplasty, and Radiofrequency Ablation. Click here to learn more about our Balloon Kyphoplasty products. Click here to learn more about our Vertebroplasty products. Click here to learn more about our Radiofrequency Ablation products. Our key Pain Therapies include: Spinal Cord Stimulation, Drug infusion systems for chronic pain, severe spasticity, RF Nerve Ablation. Click here to learn more about products. #LI-MDT 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):$76,000.00 - $114,000.00 U.S. Pay Transparency (for SIP, Commission, Hourly Direct, Interns, Executives)The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). 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.




