Clinical Research Associate jobs at ZP Group - 124 jobs

Piper Companies is actively seeking Clinical Research Associates to join a highly accredited CRO. This position is fully remote but does require travel 60-80% of the time regionally. The Clinical Research Associate will take part in a very essential role in assisting the process of creating lifesaving drugs and treatments. Responsibilities of the Clinical Research Associate: * Oversee the development and execution of the clinical trial plans and protocols for Phase I-IV * Maintain documentation and data evaluations * Work collaboratively with the team to ensure monitoring activities meet study requirements * Conduct on site field evaluations Qualifications of the Clinical Research Associate: * Experience with Oncology as a therapeutic indication * 3+ years of clinical monitoring experience, specifically with Oncology * Experience with the FDA or similar Regulatory and Accrediting administrations * Bachelor's degree in one of the life sciences or related background Compensation for the Clinical Research Associate: * Salary Range: $120,000-$135,000 * Comprehensive Benefits: Medical, Dental, Vision, 401k, and sick leave if required by law This job opens for applications on 1/20. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: Clinical Research Associate, CRA, BA, life sciences, clinical trials, phases, documentation, data, monitor, study, onsite, FDA, drugs, treatments, medical, dental, vision, 401k #LI-KI1 #LI-HYBRID

Principal Consultant- Clinical Trial Supply Management for Manufacturing, Packaging and Distribution Infosys Consulting is seeking smart, self-driven, high-energy professionals with strong communication skills, intellectual curiosity, and a deep passion for Clinical Trial Supply Management (CTSM) in the Life Sciences domain. The ideal candidate brings a strong blend of domain expertise in clinical supply operations, manufacturing, packaging, labeling, and distribution, along with business transformation consulting experience and excellent stakeholder management skills. This role will play a pivotal part in shaping the next generation of AI-enabled CTSM solutions, where intelligent, autonomous, and goal-driven AI agents proactively plan, optimize, monitor, and orchestrate end to end clinical supply operations. As a Principal Consulting professional, you will leverage your extensive professional services experience to lead large-scale transformations and help mature Infosys Consulting's CTSM and Life Sciences capabilities. You will collaborate closely with pharmaceutical and biotech clients to deliver AI-led business and digital transformations, while contributing to strategic initiatives such as thought leadership, capability incubation, and knowledge management, enabling clients to navigate the evolving global clinical research landscape. RESPONSIBILITIES Be responsible for the delivery of measurable business outcomes for leading pharmaceutical and biotechnology clients, with a focus on manufacturing, packaging, labeling, and distribution of clinical trial supplies. Provide strategic leadership and thought partnership on AI-led transformation programs, reimagining CTSM operating models across demand forecasting, supply planning, production scheduling, and distribution execution. Drive the design and deployment of intelligent CTSM solutions, leveraging autonomous AI agents for Predictive demand and supply planning, Scenario-based manufacturing and packaging optimization. Partner with technology and data teams to conceptualize and implement AI use cases across CTSM, including self-learning agents that continuously optimize Batch sizing and manufacturing runs. Enable clients to transition from reactive, rule-based planning to autonomous, goal driven supply ecosystems that adapt in real time to protocol amendments, enrollment variability, and geopolitical disruptions. Execute consulting engagements within a global delivery model, collaborating with cross-regional and cross-functional teams as part of a high-performing consulting community. Lead complex, multi-vendor and multi-stakeholder programs spanning clinical operations, supply chain, quality, IT, and external partners. Act as a trusted advisor to senior client stakeholders, influencing decision-making through data-driven insights and future-state visioning. Mentor and coach consulting team members through both formal performance management processes and ongoing informal feedback. Contribute to the growth and reputation of Infosys Consulting by developing new CTSM and Agentic AI-led offerings, authoring whitepapers, point-of-view documents, and thought leadership articles. Participate actively in firm-building initiatives, community events, and internal knowledge-sharing forums. BASIC QUALIFICATIONS Bachelor's degree or foreign equivalent required. Will also consider three years of progressive experience in the specialty in lieu of every year of education. Overall experience of 7+ years, with at least 3+ years of post-MBA consulting experience in clinical manufacturing and operations with Lifesciences clients. Experience in leading CTSM engagements for Life Sciences clients. Strong understanding of Clinical Trial solutions in the value chain area of Study Master Design and Forecasting/Planning In depth understanding of managing clinical operations using IxRT (Interactive Response Technology) Experience in developing proposals, building tools and accelerators for CTSM related services. Ability to handle conversations with senior business and technology leaders from client teams. Ability to build engaging client presentations (Expertise on MS PowerPoint, MS Word, MS Excel, MS Project). Good understanding of disruptive digital technologies Strong executive presence and ability to interact with CxO level A proven track record of leading and managing both large and small, global and local teams Manage and build long-term client relationships Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time PREFERRED QUALIFICATIONS An MBA with an advanced degree or equivalent experience Implementation experience in any Digital Supply Chain solutions - SAP IBP, Kinaxis Rapid Response, O9, E2Open, OMP etc. will be preferred. Implementation experience of Clinical Trial Supply Chain solutions with SAP ICSM Strong client-facing skills include presentations to senior leadership, advice and consult with clients. Ability to provide guidance to stakeholders in understanding business value of the initiative. Estimated annual total compensation range for this role for the New York, NY and Bridgewater, NJ area is $168,000 to $234,000. EEO/About Us : Benefits Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits: Medical/Dental/Vision/Life Insurance Long-term/Short-term Disability Health and Dependent Care Reimbursement Accounts Insurance (Accident, Critical Illness , Hospital Indemnity, Legal) 401(k) plan and contributions dependent on salary level Paid holidays plus Paid Time Off About Us Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world's top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants: • Ability to design and implement end-to-end solutions at scale • A flat organization structure with direct access to our senior-most leaders • An entrepreneurial environment full of bright, highly motivated consultants • Opportunities for motivated consultants to impact local communities • The ability to design your career and drive your professional learning and development • A truly global culture EEO Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability

Piper Companies is seeking a well-rounded Clinical Research Associate with direct oncology monitoring experience to work with a Global CRO. The Clinical Research Associate will be working remote with some travel included. Requirements for the Clinical Research Associate include: * Conducting site monitoring visits in line with GCP and ICH guidelines * Ensure project needs are met by collaborating with local sites * Oversee regulatory submissions, CRF completion, and data query resolutions * Ensure documentation is properly formatted and filed; TMF and ISF * Mentor clinical staff during visits Qualifications for the Clinical Research Associate include: * 3+ years of Oncology monitoring experience * 3+ years of onsite monitoring experience * Able to travel locally for work * Proficient in GCP and ICH guidelines * Understand Microsoft Office and mobiles devices * Strong understanding of Phase 1 oncology trials (phase 2 and 3 are welcomed) * Bachelor's degree in a related field Compensation for the Clinical Research Associate includes: * Salary range: $100,000 - $130,000 * Comprehensive benefit package: Medical, Dental, Vision, 401k match plus PTO, Sick leave as required by law, and Paid Holidays Keywords: Clinical research associate, CRA, hospital, travel, oncology, documentation, trials, trial sites, cancer, cancer research, GCP, ICH, recruitment plans, projects, project, protocol adherence, regulatory submissions, enrollment, CRF completion, data, data query, start-up phase, phase 1, trial master file, TMF, Investigators site file, ISF, mentorship, Microsoft office, mobile devices #LI-BH1 #LI-REMOTE This job opens for applications on 1/23/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Imagine what you could do here. At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. Bring passion and dedication to your job and there's no telling what you could accomplish. Dynamic, smart people and inspiring, innovative technologies are the norm here. The people who work here have reinvented entire industries with all Apple Hardware products. The same passion for innovation that goes into our products also applies to our practices strengthening our commitment to leave the world better than we found it. Join us to help deliver the next groundbreaking Apple product. Do you love working on challenges that no one has solved yet? As a member of our dynamic group, you will have the unique and rewarding opportunity to craft upcoming products that will delight and inspire millions of Apple's customers every single day. Apple's Biophotonics group is seeking a Clinical Research Scientist. The candidate will join a team of innovative scientists and engineers to develop a new generation of bio sensing technologies. The role's primary function is to support planning and executing clinical and user studies and other ongoing experimental efforts within the team. 3+ years of industry experience Experience conducting medical device user studies Background in chemistry / biology Detail-oriented and highly organized Excellent communication and interpersonal skills Bachelors degree in biology, chemistry, biomedical engineering or a related life sciences or engineering discipline Experience conducting clinical research in industry or academic settings Able to travel extensively within the US

Minimum Qualifications Education: Bachelor's degree in a life science field is required. Years of Experience:Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role. Required Skills & Abilities: Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, & company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines & EDC process. Strong verbal & written communication skills. Ability to train others in using MS Office Suite & EDC systems. Ability to meet deadlines, multitasks & prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team & independently. Ability to facilitate team meetings & teleconferences. Ability to present at internal study team meeting(s). Ability to train & mentor junior CRAs. Ability to seek new learning opportunities within & outside of the assigned project. Ability & willingness to travel. Additional Information All your information will be kept confidential according to EEO guidelines.

, INC Idexcel is a global staffing and IT services organization, with a mission to bring great people and great organizations together. Our diverse client base represents a wide range of industries, including technology, telecom, insurance, healthcare, manufacturing, banking & financial services, food & commodities trading and federal organizations. Our teams of experienced recruiters directly work with client companies seeking exceptional people to help with their business initiatives. Idexcel, Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. Job Description Clinical Research Associate I 12/19/2016 to 04/28/2017 Marlborough, MA, USA, 01752 $29.72/HR on w2 BACHELORS DEGREE REQUIRED. MUST HAVE RELEVANT 2 YEARS WORK EXPERIENCE OF CLINICAL RESEARCH.. Will be assisting physicians trying to enroll in program for diagnosis of ALZHEIMERS. Will be working with customers, must have professional demeanor, excellent communication skills. JOB TITLE: CLINICAL RESEARCH COORDINATOR LOCATION: Massachusetts - Marlborough Clinical Research Coordinator Location: Massachusetts - Marlborough Clinical Research Coordinator wanted for clinical study Job function includes, study coordination and implementation of a new clinical study. The position arranges and coordinates clinical study start up activities and plays a key role in assisting the Clinical Operations team in recruiting sites. The position works closely with the Site Principal Investigators, Clinical site personnel, members of the GEHC team, as well as with the Study Sponsors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of clinical studies. It is a full time position, Monday-Friday. Ability to travel within then US up to 20%, as needed. Positive candidate must possess the following: • Experience as a study coordinator or research assistant for 1-2 years in a hospital/outpatient setting, or within a CRO • High organizational ability with strong attention to detail • Flexibility with a team player attitude • Professionalism • Proficient with Microsoft Office, Outlook and Internet Explorer • Critical thinker and problem solver Education Requirements: 4 yr Bachelor's Degree. Clinical research experience required. Sandra Taylor ************ Additional Information Sandra Taylor ************

, INC Idexcel is a global staffing and IT services organization, with a mission to bring great people and great organizations together. Our diverse client base represents a wide range of industries, including technology, telecom, insurance, healthcare, manufacturing, banking & financial services, food & commodities trading and federal organizations. Our teams of experienced recruiters directly work with client companies seeking exceptional people to help with their business initiatives. Idexcel, Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. Job Description Clinical Research Associate I 12/19/2016 to 04/28/2017 Marlborough, MA, USA, 01752 $29.72/HR on w2 BACHELORS DEGREE REQUIRED. MUST HAVE RELEVANT 2 YEARS WORK EXPERIENCE OF CLINICAL RESEARCH.. Will be assisting physicians trying to enroll in program for diagnosis of ALZHEIMERS. Will be working with customers, must have professional demeanor, excellent communication skills. JOB TITLE: CLINICAL RESEARCH COORDINATOR LOCATION: Massachusetts - Marlborough Clinical Research Coordinator Location: Massachusetts - Marlborough Clinical Research Coordinator wanted for clinical study Job function includes, study coordination and implementation of a new clinical study. The position arranges and coordinates clinical study start up activities and plays a key role in assisting the Clinical Operations team in recruiting sites. The position works closely with the Site Principal Investigators, Clinical site personnel, members of the GEHC team, as well as with the Study Sponsors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of clinical studies. It is a full time position, Monday-Friday. Ability to travel within then US up to 20%, as needed. Positive candidate must possess the following: • Experience as a study coordinator or research assistant for 1-2 years in a hospital/outpatient setting, or within a CRO • High organizational ability with strong attention to detail • Flexibility with a team player attitude • Professionalism • Proficient with Microsoft Office, Outlook and Internet Explorer • Critical thinker and problem solver Education Requirements: 4 yr Bachelor's Degree. Clinical research experience required. Sandra Taylor ************ Additional Information Sandra Taylor ************

Salary: Clinical Research Associate Health Tech Innovation Position Type:Full Time Help Shape the Future of Health Tech Join a team at the forefront of wearable technology and digital health innovation. This is more than a monitoring roleits an opportunity to influence how next-generation medical devices improve lives. If youre an experienced Clinical Research Associate (CRA) who thrives in fast-paced environments and wants to make a tangible impact on groundbreaking clinical trials, we want to hear from you. What Youll Do Lead site qualification, initiation, monitoring, and close-out visits to ensure compliance with protocols and regulatory standards. Monitor studies with precisionverify source data, resolve queries, and maintain data integrity. Build strong relationships with investigators and site teams to ensure smooth trial execution. Drive risk-based monitoring strategies and implement corrective actions when needed. Stay ahead of the curve on FDA regulations, ICH GCP guidelines, and evolving industry trends. Collaborate cross-functionally with clinical operations, data management, and regulatory teams. Prepare detailed monitoring reports and documentation that meet the highest standards. Qualifications for success: Bachelors degree in life sciences, nursing, or related field (Masters preferred). 5 or more years in clinical research, ideally with device studies. 2 or more years as a CRA or Study Monitor with hands-on experience in IMV, SQV, etc. Experience with EDC systems and CTMS. Experience with FDA regulations, ICH GCP, and device-related compliance. Ability to travel up to 80%. CCRA, CCRP, or CPM certification preferred. Why youll love it here: Culture:At Tech Mahindra, we are a culture of driving positive change, celebrating each moment, and empowering all to Rise drives us to dream, do, and become more. Applicants can expect to make between $115,000 to $130,000 upon hire. Pay within this range will vary based upon experience, skills, certifications, education among other factors as required in the job description. Tech Mahindra also offers benefits like medical, vision, dental, life, disability insurance and paid time off (including holidays, parental leave, and sick leave, as required by law). The exact offer terms will depend on the skill level, educational qualifications, experience and location of the candidate. Tech Mahindra is an Equal Employment Opportunity employer. We promote and support a diverse workforce at all levels of the company. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, age, national origin, or disability. All applicants will be evaluated solely on the basis of their ability, competence, and performance of the essential functions of their positions with or without reasonable accommodations. Reasonable accommodations also are available in the hiring process for applicants with disabilities. Candidates can request a reasonable accommodation by contacting the company ADA Coordinator at ADA_******************************.

Piper Companies is currently seeking an Oncology Clinical Research Associate (CRA) for an opportunity in Boston, Massachusetts (MA). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the Oncology Clinical Research Associate: * Conduct site and study visits and perform all site monitoring activities across multiple study * Responsible for both remote and on-site monitoring and study activation * Participate in the development of study tools, protocols, and clinical trial documentation * Some travel required once travel bands are lifted Qualifications for the Oncology Clinical Research Associate: * 3+ years of Oncology on-site Monitoring and hands on experience with EDC Systems * Experience with Phase 1 Oncology is non-negotiable * Organization to perform monitoring duties across multiple sites is a must Compensation for the Oncology Clinical Research Associate: * Salary Range: $110,000-$135,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1

Study Participants About Prolific Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.

Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits. I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization. Job Description Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry Additional Information All your information will be kept confidential according to EEO guidelines.

Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits. I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization. Job Description Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry Additional Information All your information will be kept confidential according to EEO guidelines.

Piper Companies is seeking a Clinical Trial Specialist (TMF) to support a well-established CRO in Bethesda, MD. This role is hybrid (2 days on-site) and will play a key role in supporting clinical trial operations by ensuring the TMF is accurate, compliant and audit-ready. *This is a fast-moving position for a 4-5+ month contract* Responsibilities of the Clinical Trial Specialist: * Maintain, organize, and monitor eTMF content for completeness, accuracy, and compliance * Perform routine quality checks and provide TMF metrics and status reports to internal teams and sponsors * Ensure timely filing, retrieval, and delivery of clinical trial documents * Support audit and inspection readiness activities * Contribute to updates of SOPs, work instructions, and training materials related to TMF processes * Serve as a point of contact for TMF‑related questions and collaborate across study teams Qualifications of the Clinical Trial Specialist: * 1+ years of TMF (Trial Master File) experience working for a CRO, research institution of academia * Experience maintaining and uploading clinical trial documentation * Prior experience working for a CRO, or pharmaceutical organization * Strong database experience in Veeva Vault, eTMF, RedCap, Medidata, etc. * Bachelor's degree in science related field Compensation for the Clinical Trial Specialist: * Salary: $50,000 - $58,000 annually, commensurate with experience * Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays This job opens for applications on 1/21/2026. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: Clinical Research, Clinical Research Coordinator, CRC, CRA, Clinical Research Assistant, Clinical Trial Assistant, CTA, Clinical Trial, Clinical Operations, Study Support, Patient Recruitment, Enrollment, Trial Administration, TMF, Trial Master File, eTMF, electronic Trial Master File, Redcap, Medidata, Veeva, VeevaVault, EDMS, CTMS, Clinical Trial Management System, Study Start Up, SSU, Site Management, Document Processing, TMF Maintenance, TMF Completeness Checks, Essential Documents, Regulatory, Inspection Readiness, Audit Preparation, Regulatory Binder, Document Archival, SOP, Standard Operating Procedure, Document Tracking, ICH, GCP, Good Clinical Practice, FDA, EMA, Compliance Monitoring, IRB, Study Correspondence, Data Entry, Data Analysis, CRO, Clinical Research Organization, Pharmaceutical, Biotechnology, Site Monitoring, EDC, Electronic Data Capture, RAVE, Enrollment Tracking, Study Metrics, Trial Interactive, Wingspan, Excel, Study Dashboard, Document Tracking Log, ICF, Informed Consent Form, Protocol, Investigator Brochure, Study Timeline, Safety Reporting, Source Documents, Adverse Events, SAE, AE, Adverse Event, Clinical, Research, Infectious Disease, Oncology, Cardiology, Immunology, Contract, Hybrid #LI-BN1 #LI-HYBRID

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Job Description The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager. In this job you will: * Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution. * Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time. * Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria. * Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff. * Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed. * Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment. * Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual. * Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution. * Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments. * Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions. * Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding. * Assist site staff with maintaining appropriate temperature monitoring for study products and supplies. * Support the contract and budget negotiations and oversees Investigator/Site Payments. * Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation. * Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc. * Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections. * Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs). * May be involved in the on-site training of additional staff as part of the SEO or other education programs. * Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements. * Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II. * SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope. Qualifications Education Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects. Language Requirements Bilingual proficiency in English and Spanish is required. Certifications * Current Good Clinical Practice (GCP) * International Air Transport Association (IATA) * Current Basic Cardiopulmonary Resuscitation (CPR) * Phlebotomy certification unless part of active professional licensure (RN or LPN) * Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified. Additional Information Located in Coral Springs, Florida. (On-site position). If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Job Description The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager. In this job you will: Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution. Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time. Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria. Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff. Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed. Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment. Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual. Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution. Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments. Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions. Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding. Assist site staff with maintaining appropriate temperature monitoring for study products and supplies. Support the contract and budget negotiations and oversees Investigator/Site Payments. Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation. Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc. Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections. Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs). May be involved in the on-site training of additional staff as part of the SEO or other education programs. Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements. Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II. SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope. Qualifications Education Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects. Language Requirements Bilingual proficiency in English and Spanish is required. Certifications Current Good Clinical Practice (GCP) International Air Transport Association (IATA) Current Basic Cardiopulmonary Resuscitation (CPR) Phlebotomy certification unless part of active professional licensure (RN or LPN) Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified. Additional Information Located in Coral Springs, Florida. (On-site position). If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!

The Clinical Research Coordinator (CRC) will support the Principal Investigator (PI) in conducting industry-sponsored clinical trials. This role reports to the director of clinical research and is responsible for coordinating and conducting patient study visits, ensuring protocol compliance, maintaining accurate documentation, and managing regulatory files. Prior clinical research experience is highly desired. Key Responsibilities Conduct study visits in collaboration with the Principal Investigator in accordance with approved protocols. Perform venipuncture and process blood samples as required by study protocols. Ensure all study visits are documented accurately and completely, in compliance with protocol requirements, GCP, and regulatory standards. Enter and manage study data in electronic data capture systems, including Veeva EDC and CRIO. Maintain complete and up-to-date regulatory binders and essential trial documentation. Prepare for and support monitoring visits, audits, and inspections. Track study progress and ensure timely completion of study-related tasks. Communicate effectively with study sponsors, CROs, and internal research staff. Adhere to institutional policies, SOPs, and all applicable regulatory requirements. Work Environment & Expectations Direct patient interaction during study visits. Collaboration with physicians, research staff, sponsors, and CROs. Compliance with clinical research regulations and institutional policies. Other duties as assigned. Pay Range:The salary range for the Research Study Coordinator position is $45,000 - $66,000 per year, commensurate with experience and qualifications. FLSA Status:This position is classified as Exempt under the Fair Labor Standards Act (FLSA). EEOC Statement:Next Level Medical is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, or any other protected characteristic. Our commitment to Service-Excellence, Teamwork, Integrity, Innovation, and Compassion extends to our employment practices, ensuring fairness and equal opportunity for all. Requirements Required / Preferred Qualifications 2 years of prior experience as a Clinical Research Coordinator or similar research role strongly preferred. Hands-on experience using Veeva EDC and CRIO is strongly preferred. Proven experience performing venipuncture and handling blood samples. Familiarity with clinical trial protocols, informed consent processes, and regulatory documentation. Strong organizational skills with attention to detail. Ability to manage multiple studies and priorities simultaneously. Excellent written and verbal communication skills.

Study Participants Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.

Study Participants Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.

Study Participants Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.