Clinical research associate jobs in Santa Fe, NM - 32 jobs

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Lead Clinical Research Associate
Oracle 4.6
Clinical research associate job in Santa Fe, NM
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
$70.6k-141.2k yearly 6d ago

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Clinical Research Associate
Protrials Research 3.3
Clinical research associate job in regina, NM
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we've supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries. Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you'll join a collaborative community committed to making a meaningful impact on global health. We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence. ABOUT THE JOB The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.HERE IS WHAT YOU WILL DO: Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit including qualification, initiation, interim, and close out site visits Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion Manage, prepare, send, track, and return investigational supplies at individual sites Monitor and document investigational product dispensing, inventory, and reconciliation Monitor and document laboratory sample storage and shipment Monitor trial by reviewing and reporting on site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues Review data queries and listings, and work with the study centers to resolve data discrepancies Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues Maintain complete and accurate study files and review files to ensure all appropriate documentation is present Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials Follow Good Documentation Practices, complete Visit Reports and site correspondence in accordance with SOPs HERE IS WHAT YOU BRING TO THE TABLE: Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training 2 years of prior experience as a Clinical Research Associate preferred Detail oriented Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills Flexibility with changing priorities Ability to efficiently perform and prioritize multiple tasks Familiarity with medical and pharmaceutical industry, and related terminology and practices Extensive knowledge of FDA regulations and their practical implementation Ability to travel, including by air or by car on short notice A valid driver's license with access to a car with up-to-date car insurance Proficiency in Microsoft Word, Excel, and PowerPoint HERE IS WHAT WE OFFER: Your wellness matters to us - that's why we provide full medical, dental, and vision insurance options for you and your family. We know life doesn't pause for work - we provide flexible PTO so you can take care of what matters, both personally and professionally. You invest in your future - and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. At ProTrials, we are committed to your growth. Whether you're looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward. We have the best coworkers, if we do say so ourselves. Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant's personal information in accordance with its statutory obligations and internal policies and procedures. Information collected during application completion may be retained for a reasonable period of time and in accordance with the company's established retention policies. Applicants seeking more information may contact ****************. ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.
$59k-93k yearly est. Auto-Apply 20d ago
Sr. Clinical Research Associate - FSP
Parexel 4.5
Clinical research associate job in Santa Fe, NM
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$100k-133k yearly est. 44d ago
Clinical Scientist
Eliassen Group 4.7
Clinical research associate job in Santa Fe, NM
**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
$130k-150k yearly 7d ago
Clinical Research Manager
Serv Recruitment Agency
Clinical research associate job in Albuquerque, NM
Join the Southwest Women's Oncology Team: Southwest Women's Oncology Team (SWWO) is rapidly growing and looking for a dedicated and driven Clinical Research Manager to join their high-performance team. At Southwest Women's Oncology (SWWO), we are dedicated to helping women triumph over gynecologic illness through compassion, commitment, and exceptional care. As New Mexico's leading gynecologic treatment center, we combine expertise and compassion to offer each patient the personalized care they deserve. Our state-of-the-art treatment center offers the highest quality care for patients of all ages and medical needs. We are leaders in diagnosing, treating, and defeating gynecologic cancer. Our expert medical team, led by Dr. Karen Finkelstein, offers more than 100 years of combined experience in delivering superior medical treatment in a deeply supportive environment. SWWO is also proud to be a fellowship training partner with the University of New Mexico, fostering the next generation of gynecologic oncologists through hands-on education and mentorship. This partnership reflects our commitment to advancing the field of gynecologic oncology and ensuring the highest standard of care for our patients. The Clinical Research Manager plays a pivotal role in overseeing the daily operations and long-term integrity of the Southwest Women's Oncology (SWWO) Clinical Research Program. This position ensures that all clinical trials are conducted according to regulatory requirements, ethical standards, and internal quality expectations, while fostering a culture of collaboration, accountability, and continuous improvement. The ideal candidate brings hands-on experience in clinical research operations, a strong understanding of compliance and workflow management, and the leadership presence to guide and develop a small but growing team. This role is both strategic and operational - balancing day-to-day oversight with the development of standardized systems that position SWWO for future growth and expansion. This Role includes: Lead the daily operations of the Clinical Research team, ensuring accuracy, compliance, and efficiency across all trials. Provide hands-on leadership to Clinical Research Coordinators and support staff. Foster a cohesive and accountable team culture built on collaboration, professionalism, and respect. Develop, implement, and maintain Standard Operating Procedures (SOPs), workflows, and documentation to support consistent, high-quality research practices. Monitor study progress, participant safety, and regulatory compliance; proactively identify and resolve issues. Collaborate with clinical staff to ensure seamless coordination between research and patient care activities. Ensure all research activities are conducted in accordance with FDA, GCP, IRB, and sponsor guidelines. Oversee the preparation and submission of study-related regulatory documents. Support audit readiness and maintain accurate and complete study records. Promote a “patient safety first” mindset across all aspects of clinical research. erve as a professional and diplomatic representative for SWWO in interactions with sponsors, CROs, and external partners. Support contract and budget discussions in partnership with leadership and finance teams. Communicate study updates, enrollment performance, and issue resolution clearly and professionally. Build and sustain trusted relationships that encourage repeat collaborations. Evaluate current workflows and identify opportunities for improvement or automation. Support leadership in defining long-term goals for the Research Program, including team structure and growth pathways. Contribute to strategic discussions about expanding the research portfolio once operational foundations are fully established. Maintain excellent report with PI, Sub-I, Nursing Staff, and Patients Qualifications: Strong leadership skills with the ability to effectively communicate and create a high-performance environment. Knowledge of biological and medical terminology. Understanding of administration and management principles. Ability to coordinate therapeutic phase II-IV drug or device trials. Be adaptable, flexible, and able to change as required. Physical Requirements include: Prolonged periods of sitting and working on a computer and ability to lift up to 15 pounds as needed. Education and Experience: Bachelor's or Master's degree in Nursing, Health Sciences, or related field. Minimum 5 years of experience in Clinical Research, including at least 2 years in a leadership or senior coordinator role. Experience in oncology research is preferred, but not required - willingness to proactively learn the oncology environment is essential. Demonstrated knowledge of GCP, ICH, and FDA regulations and strong familiarity with IRB processes. Experience leading teams, developing SOPs, and implementing quality systems in a clinical research setting. Proficient in EDC systems, CTMS platforms, and electronic regulatory documentation. Strong analytical, organizational, and project management skills. Skilled in communication (written and verbal), documentation, and stakeholder engagement. Our Dream Teammate will have access to: Competitive Salary Excellent Benefits: Medical, dental, vision, PTO, and 401K High-Performance Concierge Culture Performance Center: Full AI gym suite, recovery modalities, group fitness classes, body composition tracking, and state-of-the-art aesthetic modalities. Job Type: Full-time Location: Albuquerque, New Mexico
$77k-122k yearly est. Auto-Apply 60d+ ago
Trial Master File (TMF) Specialist Oncology
Sumitomo Pharma 4.6
Clinical research associate job in Santa Fe, NM
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
$72.5k-90.6k yearly 60d+ ago
Research Administrator
New Mexico Institute of Mining and Technology 3.9
Clinical research associate job in Socorro, NM
For description, see PDF: ************ nmt. edu Research Administrator" href="/hr/Research%20Administrator%201218025. pdf
$55k-66k yearly est. 32d ago
Study Manager I (2889)
Dm Clinical Research Group
Clinical research associate job in Albuquerque, NM
A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Adherence and compliance to the assigned protocols at their respective site(s). Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s). Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s). Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner. Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner. Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation. Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines. Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial. Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site. Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree preferred Foreign Medical Graduates preferred Experience: Minimum of 5 years experience in Clinical Research Supervisory experience preferred Wide therapeutic range of clinical trials experience preferred Regulatory research experience is a plus Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Goals-driven while continuously maintaining quality. Must be detailed-oriented, proactive, and able to take initiative. Must have strong written and communication skills. Must have excellent customer service skills. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred
$56k-95k yearly est. 7d ago
Research Coordinator
Lovelace Biomedical Research Institute 3.9
Clinical research associate job in Santa Fe, NM
A full time Research Coordinator position is currently available in Dr. Kent Kiehl's laboratory at The Mind Research Network. The research coordinator will work with a team on grant-funded studies designed to evaluate neurobehavioral characteristics of incarcerated criminal offenders with antisocial (e.g., psychopathic) traits, substance use disorders, and/or past traumatic events (including traumatic brain injury). Our studies also investigate the impact of treatment (e.g., cognitive skills training) as well long-term outcomes post-release from incarceration. Research coordinators are responsible for: 1) Recruiting and scheduling participants, 2) Conducting clinical and neuropsychological assessments, 3) Analyzing data to assure data integrity, quality control and protocol compliance, 4) Training and supervising research staff and student volunteers, 5) Using statistical software to analyze data quantitatively and qualitatively, and assist in the preparation of conference presentations, manuscripts, and grant proposals. Training will be provided in the administration and scoring of clinical interviews and neuropsychological tests. Depending on interests and experience, training may also be provided in brain imaging (e.g., functional magnetic resonance imaging (fMRI)) data collection and analysis. Opportunities are also available to become involved in and/or lead research papers and publications. The majority of time will be spent collecting data in men's and women's correctional facilities. Qualifications Requires a bachelor's degree and a minimum of 2 years of related experience; or an equivalent combination of education, training and/or experience from which comparable knowledge, skills, and abilities have been attained. Candidates with a M.A are also encouraged to apply. Must have demonstrated knowledge of psychological, socio-behavioral and/or neurobehavioral research principles, practices and protocols as well as knowledge of the principles, methods, and procedures of basic medical and/or clinical research. Must have the ability to understand and follow basic scientific research protocols and procedures. Requires strong written and verbal communication skills and the ability to work independently and as a part of a team. Must have the ability to maintain confidentiality as well as the ability to learn department-specific computer systems as needed. Must have a high degree of professionalism, strong organizational and time-management skills. Demonstrated ability in managing a wide variety of tasks simultaneously while meeting multiple deadlines is required. Must have a valid driver's license and be able to pass a background check. Experience with clinical assessments and statistical methods/software is preferred. Physical Requirements Work is performed in a dry laboratory environment. Will operate standard office equipment and will frequently stand, walk, sit, perform desk-based computer tasks, use a telephone, perform repetitive motions and occasionally lift objects that weigh up to 20 pounds. May interact with research participants. Work is performed in correctional facilities. Will interact with incarcerated individuals. The above is intended to describe the general requirements for the position and should not be interpreted as an exhaustive statement of physical requirements. The Institute will provide reasonable accommodation to any employee with a disability who requires an accommodation to perform the essential functions of the position. Salary Salary is commensurate with experience. Lovelace Biomedical is an Equal Opportunity Employer
$50k-70k yearly est. Auto-Apply 13d ago
Open Rank of UNMCC in IM Hematology Oncology-ThoracicOncology & Clinical Research
University of New Mexico 4.3
Clinical research associate job in Albuquerque, NM
Posting Numberreq31072 Employment TypeFaculty Faculty TypeOpen Rank Hiring DepartmentMedical Oncology (099S1) Academic LocationSchool of Medicine Benefits EligibleThe University of New Mexico provides a comprehensive package of benefits including medical, dental, vision, and life insurance. In addition, UNM offers educational benefits through the tuition remission and dependent education programs. See the Benefits home page for more information. The University of New Mexico Comprehensive Cancer Center (UNMCCC) and the Department of Internal Medicine, Division of Hematology/Oncology at the UNM School of Medicine invite applications from physicians or physician scientists with training and expertise in medical oncology and a focused interest in clinical care and clinical/translational research for patients with thoracic and aero-digestive malignancies. The successful applicant will participate in the multidisciplinary clinical care of patients and in the design and conduct of cancer clinical trials as a member of the UNMCCC Multidisciplinary Working Group in Lung and Aerodigestive Malignancies. This is an Open Rank, Open Track position. Faculty rank and appointment will be commensurate with accomplishments. The successful applicant will have fellowship training and strong interest in the development of clinical trials and immune/targeted therapies for lung cancer. Emphasis is placed on the ability to foster interactions between laboratory and clinical investigators, participate in multidisciplinary clinical trial teams, and participate in the teaching mission of the Division and the Cancer Center. Excellent salaries, endowed positions, and start up packages are available. The University of New Mexico Comprehensive Cancer Center (UNMCCC) The University of New Mexico Comprehensive Cancer Center is the Official Cancer Center of New Mexico and the only National Cancer Institute-designated Cancer Center in a 500-mile radius. Its more than 120 board-certified oncology specialty physicians include cancer surgeons in every specialty (abdominal, thoracic, bone and soft tissue, neurosurgery, genitourinary, gynecology, and head and neck cancers), adult and pediatric hematologists/medical oncologists, gynecologic oncologists, and radiation oncologists. They, along with more than 600 other cancer healthcare professionals (nurses, pharmacists, nutritionists, navigators, psychologists and social workers), provide treatment to 65% of New Mexico's cancer patients from all across the state and partner with community health systems statewide to provide cancer care closer to home. They treated approximately 14,000 patients in about 100,000 ambulatory clinic visits in addition to in-patient hospitalizations at UNM Hospital. A total of nearly 400 patients participated in cancer clinical trials testing new cancer treatments that include tests of novel cancer prevention strategies and cancer genome sequencing. The more than 100 cancer research scientists affiliated with the UNMCCC were awarded $35.7 million in federal and private grants and contracts for cancer research projects. Since 2015, they have published nearly 1000 manuscripts, and promoting economic development, they filed 136 new patents and launched 10 new biotechnology start-up companies. Finally, the physicians, scientists and staff have provided education and training experiences to more than 500 high school, undergraduate, graduate, and postdoctoral fellowship students in cancer research and cancer health care delivery. Learn more at ***************************** Qualifications Minimum Qualifications: * MD or MD/PhD degree or equivalent with board certification in Internal Medicine * Board certification/eligibility in Medical Oncology * Experience in cancer clinical trials with a focused interest in thoracic malignancies, and * Must be eligible to work in the U.S. Preferred Qualifications: * Experience in cancer clinical trial design and conduct * Experience in resident/fellow education. * Experience in clinical and translational research. * A demonstrated commitment to diversity, equity, inclusion, and student success, as well as working with broadly diverse communities. Application Instructions Only applications submitted through the official UNMJobs site will be accepted. If you are viewing this job advertisement on a 3rd party site, please visit UNMJobs to submit an application. Complete applications will include a cover letter, curriculum vitae, and Letters of Recommendation with the names of three references with mailing address, phone numbers and email address. For all inquiries or questions, please contact: Search Coordinator: Amanda Leigh Earnest at ************ or ******************** For Best ConsiderationFor best consideration, please apply by 10/31/2024. This position will remain open until filled. The University of New Mexico is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability, or any other protected class. HEJ Inclusive Workplace Upgrade
$39k-49k yearly est. Easy Apply 60d+ ago
HSE Coordinator Senior (Carlsbad NM or Midland TX or Pecos TX)
Archrock 4.5
Clinical research associate job in Carlsbad, NM
Under general supervision, plans, develops, and coordinates health, safety and environmental compliance and specific Company HSE programs or initiatives for assigned area. Under general supervision, plans, develops, and coordinates health, safety and environmental compliance and specific Company HSE programs or initiatives for assigned area. Essential Duties * Assists with implementation of corporate incident prevention and loss control systems and programs into local operations. * Identifies and analyzes conditions which could result in incidents, environmental damage, and financial losses, evaluates their potential consequences, and works with the HSE Manager and Operations Manager to implement corrective actions. * Reports statistical data to the HSE Manager related to occupational injuries and illnesses, environmental releases and vehicle incidents. * Maintains limited liaisons with industry associations, professional associations and customers regarding HSE related issues. * Maintains awareness of developments in the HSE field. * Ensures compliance with applicable local regulations and contractual HSE requirements of customers. * Attends local customer and industry meetings regarding occupational safety and health matters. * Works closely with the local Operations Manager to ensure compliance with all policies and procedures. * Assists/leads all incident investigations in conjunction with operations personnel. * Spends the majority of their time in the field assisting operations with HSE compliance. * Ensures only approved HSE vendors are utilized for any HSE related services. * Maintains any local HSE related permits, to include ensuring that all permit requirements are met. * Assists with DOT compliance locally. * Performs regular HSE audits locally and reports findings and recommended corrective actions back to the HSE Manager. * May perform HSE training as needed. Non-Essential Duties: Performs other duties as assigned. All employees shall be in compliance with the Archrock Health Safety and Environmental Policy and local, statutory and/or regulatory requirements at all times. Essential Duties * Assists with implementation of corporate incident prevention and loss control systems and programs into local operations. * Identifies and analyzes conditions which could result in incidents, environmental damage, and financial losses, evaluates their potential consequences, and works with the HSE Manager and Operations Manager to implement corrective actions. * Reports statistical data to the HSE Manager related to occupational injuries and illnesses, environmental releases and vehicle incidents. * Maintains limited liaisons with industry associations, professional associations and customers regarding HSE related issues. * Maintains awareness of developments in the HSE field. * Ensures compliance with applicable local regulations and contractual HSE requirements of customers. * Attends local customer and industry meetings regarding occupational safety and health matters. * Works closely with the local Operations Manager to ensure compliance with all policies and procedures. * Assists/leads all incident investigations in conjunction with operations personnel. * Spends the majority of their time in the field assisting operations with HSE compliance. * Ensures only approved HSE vendors are utilized for any HSE related services. * Maintains any local HSE related permits, to include ensuring that all permit requirements are met. * Assists with DOT compliance locally. * Performs regular HSE audits locally and reports findings and recommended corrective actions back to the HSE Manager. * May perform HSE training as needed. Non-Essential Duties: Performs other duties as assigned. All employees shall be in compliance with the Archrock Health Safety and Environmental Policy and local, statutory and/or regulatory requirements at all times. Archrock is a premier provider of natural gas compression services to customers in the energy industry throughout the U.S. and a leading supplier of aftermarket services to customers who own compression equipment. With approximately 1,000 employees, our unmatched expertise and team of highly qualified, certified technicians are backed by more than 70 years of industry experience. Archrock is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$56k-86k yearly est. 42d ago
Senior Coordinator, Prior Authorization
Cardinal Health 4.4
Clinical research associate job in Santa Fe, NM
**_What Customer Service Operations contributes to Cardinal Health_** Customer Service is responsible for establishing, maintaining and enhancing customer business through contract administration, customer orders, and problem resolution. Customer Service Operations is responsible for providing outsourced services to customers relating to medical billing, medical reimbursement, and/or other services by acting as a liaison in problem-solving, research and problem/dispute resolution. **_Job Summary_** The Senior Coordinator, Prior Authorization is responsible for obtaining, documenting, and tracking payer approvals for durable medical equipment (DME) orders, including diabetes devices and other clinically prescribed supply categories (e.g., ostomy, urological, wound care). This role submits prior authorization requests through payer portals or via fax, and conducts phone-based follow-ups with payers and provider offices to secure timely approvals. The Senior Coordinator proactively manages upcoming expirations to prevent order delays, meets daily productivity targets, and adheres to quality, compliance, and HIPAA standards. **_Responsibilities_** + Review assigned accounts to determine prior authorization requirements by payer and product category. + Prepare and submit complete prior auth packets via payer portals, third-party platforms, or fax (including DWO/CMN, prescriptions, clinical notes, and other required documentation). + Conduct phone-based follow-ups with payers (and provider offices when needed) to confirm receipt, resolve issues, and obtain approval or referral numbers. + Log approvals accurately so orders can be released and shipped; correct rejected/pending decisions by addressing missing documentation or criteria. + Monitor upcoming prior auth expirations and initiate re-authorization early to prevent delays on new and reorder supply shipments + Prioritize work to give orders a "leg up" based on aging, SLA, and payer requirements. + Capture all actions, decisions, and documentation in the appropriate systems with complete, audit-ready notes. + Ensure secure handling of PHI and maintain full compliance with HIPAA, regulatory requirements, and company policy. + Promptly report suspected non-compliance or policy violations and attend required Compliance/HIPAA trainings. + Achieve daily throughput goals (accounts/records per day) across mixed work types (portal/web, fax, phone). + Meet standardized quality metrics through accurate documentation and adherence to process; participate in supervisor live-monitoring, QA reviews, and 1:1 coaching. + Share payer/process knowledge with teammates and support a strong team culture. + Adapt to changes in payer criteria, portals, and internal workflows; offer feedback to improve allocation, templates, and documentation standards. + Perform additional responsibilities or special projects as assigned. **_Qualifications_** + High School diploma, GED or equivalent work experience, preferred + 3-6 years of experience in healthcare payer-facing work such as prior authorization, insurance verification, medical documentation, revenue cycle, or claims, preferred + Proven ability to meet daily productivity targets and quality standards in a queue-based environment. + Strong phone skills and professional communication with payers and provider offices; comfortable with sustained phone work. + High attention to detail and accuracy when compiling documentation (DWO/CMN, prescriptions, clinical notes). + Self-motivated with strong time management; able to pace independently without inbound-call cadence. + Customer-centric mindset with a sense of urgency; capable of multitasking (working web/portal tasks while on calls). + Working knowledge of HIPAA and secure handling of PHI. + Experience with diabetes devices (CGMs, insulin pumps), and familiarity with ostomy, urological, and wound care product categories, preferred. + Knowledge of payer criteria for DME prior authorization, including common documentation requirements and medical necessity standards, preferred + Familiarity with payer portals and third-party platforms; experience with Grid or other work allocation tools, preferred. + Exposure to ICD-10/HCPCS coding and basic authorization/claims terminology, preferred, **_What is expected of you and others at this level_** + Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments + In-depth knowledge in technical or specialty area + Applies advanced skills to resolve complex problems independently + May modify process to resolve situations + Works independently within established procedures; may receive general guidance on new assignments + May provide general guidance or technical assistance to less experienced team members **Anticipated hourly range:** $16.75 per hour - $21.75 per hour **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 03/08/2026 *if interested in opportunity, please submit application as soon as possible. _The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity._ \#LI-DP1 _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************
$16.8-21.8 hourly 13d ago
Research Coordinator - Woodward/CT Research, (424)
Tricore Reference Laboratories 4.6
Clinical research associate job in Albuquerque, NM
Schedule: Monday-Friday 0800-1630 with other shifts as needed Responsible for managing many aspects of conducting device trials, specimen procurement projects, consenting collections, and testing for research clients both from internal (hospital based, Medical Director- Researchers) and external clients. Serves as central coordinator of study activity at the research site, acting as liaison between the investigator and all internal and external contacts. Responsible for a variety of complex tasks requiring independent judgment regarding the pre-implementation and implementation phases of a study or collection, such as feasibility discussions, contract and budget preparation, study startup activities, subject recruitment and enrollment, maintenance of the study, data management, and study closure. Participate as effective team member in section management relative to communications and operations as appropriate. ESSENTIAL FUNCTIONS: 1. Review and evaluate protocols and requests with Principal Investigators (PI) and/or research team for feasibility. 2. Create budgets for study or project and submit to appropriate process for review and approval. 3. Prepare, implement, and assist in the approval of study start-up documents, worksheets, presentations, and activities. 4. Serve as a liaison with study Principal Investigators and internal and/or external clients regarding study or project set up, logistics, and progress 5. Design data collection forms, such as case report forms (CRF), manifests, or sample accountability logs (SALs) as necessary. 6. Handle inquiries regarding the protocol, case report forms and other areas related to the study or project. 7. Conduct subject interviews and obtain Informed Consent. 8. Ensure timely and accurate completion and shipping of all study materials. 9. Comply with documentation and procedural requirements including (but not limited to): Case report form completion, Enrollment reports, Adverse event and dropout updates, Handling and labeling of samples, and Proper shipment of materials. Address queries in a timely manner. Maintain quality assurance, regulatory documents, recording and reporting study status information to verify that data entered on the CRF is accurate and complete 10.Coordinates with all appropriate internal departments regarding research studies or projects including: Information Technology, Accounting, laboratory department supervisors, managers, and technical specialists. 11.Participate in site audits by regulatory agencies when necessary. 12.Ensure all study or project supplies are accounted for. 13.Archive study documentation and correspondence. Training 1. Establish, maintain, and document appropriate training and competency programs necessary for device trials or procurement projects. 2. Schedule logistics meetings with study team to ensure understanding of the study workflow and workload. Inventory Control 1. Provide appropriate inventory control of study investigational use kits/reagents, study supplies, and study gift cards. Organizational / Employee Development 1. Organize daily work to meet the study milestones or deadlines. 2. Actively solicit staff input and feedback. Listen with the purpose of understanding employee concerns, questions, ideas and opinions. 3. Actively support and implement department procedures, polices and strategies to support the corporate vision, values and strategic plans. 4. Assist with marketing of the section(s) services through client contact, providing information for marketing brochures, and tours to community groups as appropriate. 5. Communicate with department management team and staff to ensure appropriate sharing of information. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. MINIMUM EDUCATION: Associates degree in a relevant field. MINIMUM EXPERIENCE: One (1) year of relevant work experience in a healthcare or clinical laboratory setting. PREFERENCES: Certification as a Research Coordinator. Patient or physician interaction experience. Clinical research experience. Knowledge of Salesforce, Compliance360, and Sunquest computer programs IMMUNIZATION REQUIREMENTS: Prove immunity to Hepatitis B or be immunized or sign a waiver refusing hepatitis immunization. Provide documentation of a PPD test conducted not more than 90 days prior to date of hire or have a PPD test conducted. GENERAL REQUIREMENTS: 1. Working knowledge of statistical and variance analysis. 2. Skilled in organization and attention to detail. 3. Ability to effectively communicate with individuals in varying socio-economic and educational backgrounds. 4. Ability to manage multiple projects at one time. 5. Ability to meet deadlines and target goals. 6. Ability to organize and direct workflow. 7. Ability to develop budgets and monitor expenditures. 8. Ability to conduct the project in a professional manner while in the presence of subjects, peers, sponsors, monitors or physicians. 9. Ability to work both independently and as a team member. Working knowledge of computers, both personal and mainframe, and at least one word processing and spreadsheet program.
$53k-74k yearly est. 60d+ ago
Clinical Research Coordinator
Eye Associates of New Mexico 4.2
Clinical research associate job in Albuquerque, NM
Eye Associates of New Mexico has an outstanding career opportunity in our Vision Research Department. Eye Associates of New Mexico is the largest Ophthalmology and Optometry practice in the Southwest. We serve our communities with compassionate, state-of-the-art and valued based care. Our team approach aims to deliver the highest quality eye care to all. We take pride in giving the absolute highest level of patient care provided by our employees and we strive to support their professional development. We are currently looking for a full-time Clinical Research Coordinator. Come be a part our team and help make a difference in our patients' vision. Some Job Duties May Include: Involved in department-specific clinical studies and maintains subject records Attends investigator/coordinator meetings as required by study sponsor and Vision Research Center meetings Assists the PI and/or Site Director in the feasibility of clinical research protocols Assists in preparing for pre-study site visits and site initiation visits Reads and understands the protocol and becomes familiar with study inclusion/exclusion criteria Under the direction of the PI, performs study related procedures per the protocol visit schedule and refers to PI, Sub-I, Clinical Research Site Director and/or Senior CRC for any study related or patient related questions. Maintains HIPAA compliance Accountable for test articles Ensures each candidate has completed all study related procedures Participates in the collection and review of medical history and concomitant medications Enters data for specific visit and transmits data/logs Plans and carries out programs for the recruitment, screening, enrollment, and retention of clinical research subjects and/or volunteers Skills/ Requirements: Must have prior clinical research coordinator experience Priority will be given to ACRP Certified Clinical Research Coordinators vs. Non-Certified Coordinators. Minimum of 3 years' experience Must demonstrate accurate typing skills at a minimum of 35 words per minutes Generous Benefits: Paid Time Off (PTO) Eight (8) Company Paid Holidays Medical and Dental Generous Vision Benefits Flexible Spending Accounts Company Paid Life and AD&D Insurance, Short Term and Long Term Disability Insurance Voluntary Supplemental Life and AD&D Insurance Employee Assistance Program 401(k) and Roth Financial Wellness program and much more Eye Associates of NM is a safe team oriented culture supporting a drug-free work environment. To learn more about this position and our organization, please visit ************* AA/EOE/Disability. Eye Associates of New Mexico is a drug and tobacco-free employer. Req.# 2743
$62k-78k yearly est. Auto-Apply 60d+ ago
Clinical Competency Coordinator/RMA Preferred
El Centro Family Health 4.1
Clinical research associate job in Espanola, NM
Job Description As a Federally Qualified Health Center, 501c3, our mission is to provide affordable, accessible, quality health care to the people of Northern New Mexico. We strive to improve the quality of life by bringing primary health care and basic health education to the people of Northern New Mexico through a system of clinics and cooperative programs. El Centro offers vital health services in a caring and supportive environment. El Centro Family Health is seeking a full-time Clinical Competency Coordinator/RMA preferred, dedicated to serving the needs of our community. An ideal candidate should possess the following qualities: Strong interpersonal communication skills and the ability to work effectively with a wide range of constituencies in a diverse community. Attention to detail. Willing to travel to outlying clinics as needed. Excellent communication skills. Knowledge and fluent skills of Microsoft Office Excel and Word applications, internet explorer usage, and Outlook. Responsibilities Under the direction and supervision of the Regional Nurse Manager or Director of Nursing, the Clinical Competency Coordinator assures and maintains the overall clinic operation in the successful delivery of quality patient care and functions as liaison between Regional Nurse Manager or Director of Nursing and Clinic Nursing Personnel. Employees are responsible for overseeing clinical competencies throughout the nursing department with new and existing employees. Will play a vital role in the orientation process for Medical Assistants throughout the 90-day introductory period. Employees assist in planning and organizing training to maintain, and implement new clinical skills, and/or competencies within the organization. Is familiar with medical terminology, the names of instruments, how to interact with patients and provides patient care and other related clinical, laboratory, technical and support to Physicians, Midlevel Practitioners, and Licensed Nurses to provide direct patient care following El Centro Family Health (ECFH) Policies and Procedures. May be required to travel to perform work assignment at any ECFH Medical Clinic. The Clinical Competency Coordinator acts as a member of the Nurse Management Team to help assist in the overall clinical operations with nurses, clinic managers and nurse managers by acknowledging, adhering to, and implementing overall organizational and medical policies and operating procedures of ECFH. Maintains established departmental policies and procedures, objectives, quality assurance, safety, environmental and infection control standards. Employees must gather, analyze, and process information for accurate and responsible decision-making. Position requires ability to listen and evaluate component parts of communications, in order to reach accurate objective conclusions. Position requires ability to explain procedures and processes, both orally and in written form. Employees are not delegated authority to commit to the company in the expenditure of funds or the adoption of changes in policy or procedure. However, employees are responsible for identifying correct answers and recommending action with a high degree of reliability. Employees may order supplies for department operation. Employees communicate verbally with co-workers, patients and clients, and members of the public. Such communication must be correct, clear, and understandable. Written communications require review, signature, and/or clearance by the supervisor. Errors by the employee may result in public and employee inconvenience, dissatisfaction, and potential legal action; errors may also result in liability to El Centro Family Health in terms of fines, fees, or other penalties. Description of Controls: Charting and other documentation is subject to supervisory review, as part of the Quality Assessment/Assurance process. Because the employee has access to personal and professional data regarding individual patients and their families, an essential job result is the maintenance of a high level of confidentiality of the information processed by the employee. Violation of this confidence may result in disciplinary action, including termination of employment. Minimum Requirements Education: High school diploma or GED equivalent. Experience: Minimum of one-year experience working in the health care field preferably in a clinical setting. Certification: Cardiopulmonary Resuscitation (CPR) or Basic Life Support (BLS). Preferred Requirements Experience: Minimum of one-year experience in supervisory role in a clinical or hospital setting. Certifications: Registered Medical Assistant Certification - (must be obtained within 15 months of hire). If obtained through American Allied Health by productively working for El Centro Family Health for a year, then six months of service through El Centro Family Health is required after certification. Failure to comply with this will result in the employee reimbursing El Centro Family Health for the American Allied Health registration fee. Benefits 401 k Retirement 7 Paid Holidays Medical, Dental, Vision Insurance 100% Employer Paid Basic Life Insurance Employee Voluntary Supplemental Benefits Employee Assistance Program Flexible Spending Account (FSA)
$52k-66k yearly est. 7d ago
Lead Clinical Research Associate - Pipelining for Future Jobs
Protrials Research 3.3
Clinical research associate job in regina, NM
Thank you for considering a future career with ProTrials. While we are not currently hiring for this position at this time, we like to connect with skilled individuals interested in future opportunities. By submitting your application, you will be added to our talent pipeline and considered if a good match becomes available. ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we've supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries. Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you'll join a collaborative community committed to making a meaningful impact on global health. We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence. ABOUT THE JOBThe Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them. HERE IS WHAT YOU WILL DO: Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies Create annotated visit report templates and other documents and strategies related to site management and monitoring Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed HERE IS WHAT YOU BRING TO THE TABLE: RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training Previous CRA experience preferred Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy Solutions-oriented approach to problem solving Familiarity with medical and pharmaceutical industry, and related terminology and practices Extensive knowledge of Food and Drug Administration regulations and their practical implementation Willingness to travel and perform remote and on-site monitoring, if needed Proficiency in Microsoft Word, Excel, and PowerPoint HERE IS WHAT WE OFFER: Your wellness matters to us - that's why we provide full medical, dental, and vision insurance options for you and your family. We know life doesn't pause for work - we provide flexible PTO so you can take care of what matters, both personally and professionally. You invest in your future - and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. At ProTrials, we are committed to your growth. Whether you're looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward. We have the best coworkers, if we do say so ourselves. Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant's personal information in accordance with its statutory obligations and internal policies and procedures. Information collected during application completion may be retained for a reasonable period of time and in accordance with the company's established retention policies. Applicants seeking more information may contact ****************. ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.
$59k-93k yearly est. Auto-Apply 60d+ ago
Sr. Clinical Research Associate - Oncology - FSP
Parexel 4.5
Clinical research associate job in Santa Fe, NM
The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$100k-133k yearly est. 43d ago
Specialist, Clinical Business Operations, Oncology
Sumitomo Pharma 4.6
Clinical research associate job in Santa Fe, NM
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
$72.5k-90.6k yearly 60d+ ago
Clinical Research Coordinator I (2681)
Dm Clinical Research Group
Clinical research associate job in Albuquerque, NM
The Clinical Research Coordinator I will work at site to help ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training, as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Any other matters, as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: 1+ years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. 2+ years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
$48k-70k yearly est. 12d ago
Clinic Coordinator Truchas
El Centro Family Health 4.1
Clinical research associate job in Truchas, NM
As a Federally Qualified Health Center, 501 ©, our mission is to provide affordable, accessible, quality health care to the people of Northern New Mexico. Do you want to be part of an organization that is dedicated to wellness and excellence of care? El Centro Family Health is seeking a Full-Time Clinic Coordinator dedicated to serving the needs of our community. Ideal candidate should possess the following qualities: Strong interpersonal communication skills and the ability to work effectively with a wide range of constituencies in a diverse community. Attention to detail. Willing to travel to outlying clinics as needed. Excellent communication skills. Knowledge and fluent skill of Microsoft Office Excel and Word applications, internet explorer usage, and Outlook. Understanding of insurance billing and claims processing. Ability to relate data elements, and ability to evaluate discrepancies in data and documents using defined sources of information, attention to detail. Ability to understand and evaluate theoretical concepts and translate them into clear directions and courses of action. Ability to work with staff around problems affecting provider scheduling, patient flow, and patient/public interaction. Responsibilities Under the direction and supervision of the Regional Administrator the Clinic Coordinator is responsible for overseeing the day-to-day operations, ensuring the processing of patient payments, preparation of certain patient and insurance billing, purchase orders, and/or documentation for financial disbursement and reimbursements. Assures accurate and timely preparation of reports. Ensures that all administrative tasks are completed in an accurate and timely manner and that Clinic Operations are flowing efficiently. The Clinic Coordinator has access to personal data regarding individual patients and families, and/or sensitive company financial data. It is essential to maintain a high level of confidentiality in accordance with HIPAA. The Clinic Coordinator is responsible for managing the clinic operations. This position is responsible for the oversight of patient scheduling, clinic complaints, staff issues, financial reporting, various clinic inspections, the overall health and safety of clinic operations, team huddles and facilitating monthly staff meetings. This position also includes training and mentoring staff and balancing the end of month financial reports. Minimum requirements Education: High school diploma or equivalent required. Experience: 1 year of management and customer service experience in related field required. Preferred Experience Three (3) years' experience in managing a health care office or related facility, two (2) years must have been in a supervisory capacity in health care or other related industry. AA Degree in Business, Finance, or equivalent academic study. At least (1) year experience in medical records working in a hospital or clinic setting. Bi-lingual- English /Spanish. Experience with medical terminology and health insurance claims, Medicaid, and Medicare.
$52k-66k yearly est. 60d+ ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Santa Fe, NM?

The average clinical research associate in Santa Fe, NM earns between $46,000 and $109,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Santa Fe, NM

$71,000

$46,00010%

$71,000Median

$109,00090%

What are the biggest employers of Clinical Research Associates in Santa Fe, NM?

The biggest employers of Clinical Research Associates in Santa Fe, NM are:

Oracle

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Clinical Research Associate Santa Fe, NM Jobs

Clinical research associate jobs in Santa Fe, NM - 32 jobs

Lead Clinical Research Associate