Clinical Research Associate jobs at Collabera - 97 jobs

IDR is seeking a Clinical Research Associate to join one of our top clients in Los Angeles, CA. This role offers a unique opportunity to work onsite, fostering close collaboration with our client's team and immersing yourself in a dynamic work environment. If you are eager to be part of a growing organization with a team-oriented culture, please apply today! Position Overview/Responsibilities for the Clinical Research Associate: • Collaborate with the team to submit research projects for human subjects approval, including protocols, consent forms, and IRB applications. • Manage internal documentation for contract execution and maintain communication with contracting officers and sponsors during budgeting and negotiations. • Develop and monitor research project budgets, ensuring alignment with protocol requirements and institutional costs. • Ensure compliance with IRB, FDA, OHRP, HIPAA, and other guidelines by maintaining high-quality regulatory files and submitting necessary paperwork. • Coordinate site feasibility and initiation visits, and provide facility tours for research sponsors and other personnel. Required Skills for Clinical Research Associate: • High School Diploma or GED is required; a Bachelor's degree is preferred. • At least one year of experience in clinical research, with a preference for experience in chemo, oncology, or pharmaceutical research. • Strong organizational skills and attention to detail in managing research documentation and regulatory compliance. • Ability to collaborate effectively with internal and external investigators and participating centers. What's in it for you? Competitive compensation package Full Benefits; Medical, Vision, Dental, and more! Opportunity to get in with an industry-leading organization Close-knit and team-oriented culture Why IDR? 25+ Years of Proven Industry Experience in 4 major markets Employee Stock Ownership Program Medical, Dental, Vision, and Life Insurance ClearlyRated's Best of Staffing Client and Talent Award winner 12 years in a row

A healthcare technology company is seeking a Project Manager to support the Clinical Intelligence team. The ideal candidate will manage project timelines, coordinate across teams, and facilitate communication for quality delivery. Responsibilities include tracking project progress, documenting processes, and helping to scale operations effectively. Bachelors or relevant experience preferred. Compensation ranges from $110K to $130K, along with equity and a bonus. Potential hybrid work model with great benefits. #J-18808-Ljbffr

Employment Type Full time Department Product Compensation $110K - $130K • Offers Equity • Offers Bonus Today, when you go to your doctor and get referred to a specialist (e.g., for sleep apnea), your doctor sends out a referral and tells you, “They'll be in touch soon.” So you wait. And wait. Sometimes days, weeks, or even months. Why? Because too often specialists and medical services are overwhelmed with referrals and the painstakingly manual process it takes to qualify your referral prevents them from getting around to it on time, or sometimes at all. Tennr prevents these delays and denials by making sure every referral gets where it needs to go, with the right info, at the right time. Powered by RaeLM™ Tennr reads, extracts, and acts on every piece of patient information so providers can capture more referrals, slash denials, and reduce delays. Role Description This role supports the Clinical Intelligence team by keeping qualification projects organized, moving, and aligned. The Project Manager acts as the orchestrator who drives work from intake through delivery, translating structured information from QA Specialists and reviewers into clear tasks, timelines, and ownership. They ensure customer reviews, new rollouts, and internal cleanup cycles move smoothly, with nothing slipping through the cracks. This role is essential to helping the qualification organization scale without losing quality, consistency, or speed. Responsibilities In this role, you will: Own project timelines and manage all phases of qualification work from intake to completion Coordinate across CSMs, QA Specialists, reviewers, and Product to keep builds aligned and progressing Break down intake information into clear action items with defined owners, expectations, and deadlines Track progress across workstreams and surface risks or blockers early Facilitate cross-functional communication to ensure each team understands next steps and deliverable expectations Support customer review cycles, rollout planning, and internal operational cleanup Maintain accurate documentation, templates, and workflows that help the team scale efficiently Ensure all deliverables meet internal quality standards and customer expectations Partner closely with Clinical Intelligence leadership to refine processes and drive continuous improvement Candidate Qualifications Required Experience managing projects or programs in a fast‑paced, cross‑functional environment Ability to manage multiple workstreams at once with strong prioritization and follow‑through Proven experience driving timelines, coordinating across teams, and ensuring high‑quality delivery Strong communication skills with the ability to translate complex information into clear tasks and expectations Comfort identifying risks, surfacing issues, and proactively resolving blockers High attention to detail with strong organizational habits Familiarity with project management tools such as Asana, Monday, Jira, or similar Ability to work effectively with both technical and non‑technical partners Strong documentation skills and the ability to maintain structured processes as the team grows Preferred Experience working with Customer Success, Product, QA, or clinical operations teams Background in healthcare operations, medical review workflows, or SaaS environments Familiarity with qualification, review, or data‑validation work Experience working in a growth‑stage or rapidly scaling organization Exposure to centralized operational or intelligence‑focused functions Why Tennr? Drive Impact: one of our company values is Cowboy, meaning you set the pace. You won't just talk about things, you'll get them done. And feel the impact. Develop Operational Expertise: learn the inner workings of scaling systems, tools, and infrastructure Innovate with Purpose: we're not just doing this for fun (although we do have a lot of fun). At Tennr, you'll join a high‑caliber team maniacally focused on reducing patient delays across the U.S. healthcare system. Build Relationships: collaborate and connect with like‑minded, driven individuals in our Chelsea office 4 days/week (preferred) Free lunch! Plus a pantry full of snacks. Benefits New, spacious Chelsea office Unlimited PTO 100% paid employee health benefit options Employer‑funded 401(k) match Competitive parental leave Compensation Range: $110K - $130K #J-18808-Ljbffr

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: * 2+ years of Oncology monitoring experience * 2+ 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: $90,000 - $120,000 * 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 1/9/2025. Applications for this job will be accepted for at least 30 days from the posting date.

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.

Piper Companies is currently seeking a Clinical Research Associate (CRA) for an opportunity in Chicago, Illinois (IL). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the 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 Clinical Research Associate: * 2-4 years performing on-site monitoring and hands on experience with EDC Systems * Experience with Oncology is highly advantageous * Organization to perform monitoring duties across multiple sites is a must Compensation for the Clinical Research Associate: * Salary Range: $100,000-$120,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1

, 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: Contract or 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. Contract hourly rate is $55.00-62.00 / hour USD (contractors are not eligible for benefits under Tech Mahindra). 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_******************************.

Collabera Inc (Staffing Firm). We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization with operations in more than 100 countries and has more than 50,000 employees around the world. For eight consecutive years, Fortune has named this company as World's ‘Most Admired Companies to work for'. Job Description Position Description: The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements. Position Responsibilities: • Prepare and revise study materials and/or training • Conduct training of site and/or Medtronic staff • Assist in site initiation activities (e.g. study start-up documentation preparation) • Set-up and maintain accurate progress and study status tracking logs • Assist in the preparation of reports, regulatory submissions, publications and presentations • Assist in the preparation of budgets and project plans • Identify and mitigate quality risk and/or issues associated with assigned studies/activities • May arrange conference calls, staff meetings, and training events. • Assist in the preparation and review of data • Oversee follow-up and resolution of sites issues • Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines • Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks • Contribute to process improvement initiatives and participate in training to enhance knowledge Qualifications Basic Qualifications: • Bachelors degree • 4+ years' experience in clinical research (Masters degree will substitute for 1 year experience) Desired/Preferred Qualifications: • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies • Proficient knowledge of medical terminology Additional Information If you are interested and want to apply, please contact: Ebrahim Sayarwala ebrahim.sayarwala(at )collabera.com ************

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.

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!

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!

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.