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American Regent, Inc. logo
American Regent, Inc.

Reliable. Responsive. Respected.

Clinical R&D - Pharmacokinetics & Bioequivalence Intern

Clinical ResearchClinical ResearchFull TimeRemoteEntry LevelTeam 501-1,000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

102 days ago

Salary

0

Seniority

Entry Level

No structured requirement data.

Job Description

Clinical R&D - Pharmacokinetics & Bioequivalence Intern

American Regent, Inc.

The Clinical Research & Development (R&D) intern will assist in the day-to-day operations of the Clinical Pharmacokinetics/Bioequivalence (PK/BE) function, including but not limited to, Project relevant literatures review, organizing the internal folders, support departments efforts in the preparation and improving standard operating procedures, data analysis methodologies. Reviewing study reports, status updates and other project development activities. Ability to complete the entire 13 -week program (from May 18, 2026 to August 14, 2026) and commit to 40 hours per week. This internship can either be onsite at our New Albany, OH facility or Remote. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. - Assist PK/BE team in reviewing literature and summarizing important information. - Learn and inform novel research methodologies in pharmacokinetics and bioequivalence studies. - Assist PK-BE team in organizing and maintaining project specific folders. - Provide hands-on support to PK/BE data analysis and summaries. - Review and summarize Bioanalytical methods and study data. - Research and adopt novel biostatistics methodologies relevant for in vitro, in vivo bioequivalence conclusions. - Prepare manuscripts and in -house presentations. - Assist R&D, RA, and CQA colleagues on support requests. - Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. - Currently pursuing a Bachelor’s, Master’s, or PhD, Pharm.D. or Ph.D. degree Pharmaceutical Sciences, Bioanalytical, quantitate systems pharmacology, Biology or related field. - Pre-med or Medical student with interest in Early-stage Clinical Development or Pharmaceutical product development. - Completed at least one semester course work in Pharmacokinetics, Pharmacotherapy or Analytical chemistry, Biology, Chemistry, or Biostatistics. - Knowledge in GMP/GLP regulations. - Insight in using Phoenix/WinNonlin, R/R-studio, SAS and other data analysis programs. - Attention to detail and able to follow instructions and operating procedures. - Excellent organizational, interpersonal, written and oral and communication skills required. - Proficiency in Microsoft Office Word and Excel is highly desirable. Physical Environment and Requirements - While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear. - Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. - Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. - Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. - Employee must be able to occasionally lift and/or move up to 50 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. - FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf - Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) - Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

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Siemens Healthineers logo

Clinical Trials Internship

Siemens Healthineers

We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Clinical Research102 days ago
Full TimeRemoteTeam 10,001+H1B No Sponsor

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Acquires further qualification for a Bachelor's degree, and gathers respective working experience in different technical fields of expertise, in the course of a respective assignment. Siemens Healthineers is seeking a Summer Intern to assist our Clinical Trials team. As a clinical trials intern, you will gain hands-on experience supporting clinical trial activities ensuring regulatory requirements are met and compliance with standard operating procedures. We provide a flexible and dynamic work environment that encourages personal and professional development beyond conventional boundaries. If you are interested in contributing to our global team as a Clinical Trials Intern, we invite you to apply. PLEASE NOTE: This is a fully remote internship opportunity This is a role well suited for a highly motivated student looking to build their skill set and gain hands-on experience. As a Clinical Trials Intern, you will be responsible for: - Assisting with monitoring visit preparation using CTMS, ensuring all required documentation is ready for site monitoring visits. - Provide administrative and organizational support for Clinical Study Report (CSR) development for a new study. - Help configure templates for invoicing, visit letters, and other essential documents in CTMS and eTMF systems. - Maintain and update training records for study team members, ensuring compliance with SOPs and regulatory requirements. - Contribute to the development of clinical study reports as needed - Monitoring and ensuring the team is in compliance with all standard operating procedures. 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Please note you may or may not hear back about opportunities immediately and will remain in consideration against opportunities as they arise unless otherwise contacted or you choose to withdraw your candidacy. This position is open to candidates who are permanently authorized to work in the United States. We are unable to support visa sponsorship for this role now or in the future, including for those currently utilizing F-1/OPT, H-1B, or other employment-based work visas. Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here. Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.” Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

United States
$24 - $40 / hour
Job Closed
Full TimeRemoteTeam 501-1,000H1B Sponsor

• Provides statistical input into Phase I - IV clinical trial development • Performs the analysis of clinical trial data • Provides statistical input into the reporting of clinical trial results • Works independently and functions as a lead statistician on clinical trials

Massachusetts
$114K - $170K / year
Job Closed
Full TimeRemoteTeam 10,001+H1B No Sponsor

We are currently seeking experienced Ophthalmology CRAs to lead and support our Full Service Outsourcing team. Open to major hub locations on the West Coast. 60-70% travel, 8-10 DOS per month. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: - Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - - Responsible for all aspects of site management as prescribed in the project plans - General On-Site Monitoring - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study - Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements - Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data - Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested - Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs - Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management - Assist with training of new employees, eg. co-monitoring - Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned - Perform other duties as assigned by management Requirements - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) - 1-3 years of Clinical Monitoring experience - Ophthalmology experience as a CRA - Open to various hub locations The important thing for us is you are comfortable working in an environment that is: - Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. - Changing priorities constantly asking you to prioritize and adapt on the spot. - Teamwork and people skills are essential for the study to run smoothly. - Technology based. We collect our data directly into an electronic environment. What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: - Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) - 401(K) - Paid time off (PTO) – Flex Plan - Employee recognition awards - Multiple ERG’s (employee resource groups) - Target Pay Range (based on title): $105-125K Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.

United States
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Novartis logo

Senior Clinical Research Associate (Remote Position)

Novartis

Novartis is a leading global pharmaceutical and healthcare research and solutions company dedicated to improving patient lives by uncovering solutions to curren

Clinical Research102 days ago

Band Level 3 Job Description Summary This is a Remote Based position. Candidates must be located near an airport (Chicago, St Louis, Detroit, Philadelphia, Baltimore, New York or New Jersey- highly desirable locations). The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Pharma clinical trials within the country. The Senior CRA is responsible for delivering data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel. LI-#Remote Job Description Key Responsibilities: Trial Monitoring strategy: • Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis) Allocation, initiation and conduct of trials: • Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries • Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures • Facilitates the preparation and collection of site and country level documents • Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required. • Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety. • Accountable for continuously updating all relevant electronic systems to perform job functions • Takes on the responsibility as SME (Subject Matter Expert) as needed Delivery of quality data and compliance to quality standards: • Monitors studies as per current legislations, ICH/GCP and Novartis standards • Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. • Identifies, resolves & escalates issues appropriately • Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry • Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities •Partners with SSU CRA to ensure seamless transition of site responsibility Essential Requirements: • BS/BA degree. Scientific, Healthcare or other related field. • Excellent knowledge of the drug development process specifically clinical trial/research • Knowledge of international standards (GCP/ICH, FDA, EMEA) • Ability to manage multiple priorities and manage time efficiently. • Excellent Site management capabilities with demonstrated negotiating and problem-solving skills • Strong communicator and presentation skills (oral and written) • Fluent in both written and spoken English Desirable Requirements: • Minimum of 3 years of experience in site monitoring strongly preferred • RLT, CAR T or Oncology experience a plus! The salary for this position is expected to range between $108,500 and $201,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver’s license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings Salary Range $108,500.00 - $201,500.00 Skills Desired Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences

United States
$108K - $201K / year
Job Closed