clinical trial associate

Piper Companies

<div>
 
 Piper Companies
 
 is looking for an
 
 In-House Clinical Research Associate
 
 to join a clinical research company located in
 
 Bethesda, MD.
 
 
 
 
 Responsibilities of the In-House Clinical Research Associate include:
 
 
 
 <ul>
 <li>
 Review and process essential regulatory documents received from clinical trial sites
 </li>
 <li>
 Request missing or additional documentation and respond to protocol or process-related inquiries
 </li>
 <li>
 Maintain and organize Trial Master Files (TMF) and centralized document systems
 </li>
 <li>
 Track regulatory documents and workflow in a centralized web-based system or database
 </li>
 <li>
 Ensure documents meet FDA, ICH GCP, and sponsor requirements for accuracy and completeness
 </li>
 <li>
 Troubleshoot regulatory document issues and follow up with study sites as needed
 </li>
 <li>
 Support distribution of trial-related materials and assist with study team coordination
 </li>
 <li>
 Assist with monitoring visit preparation and follow-up, including teleconference coordination
 
 
 </li>
 </ul>
 
 Qualifications for the In-House Clinical Research Associate include:
 
 
 
 <ul>
 <li>
 3&ndash;5 years of experience in a clinical research setting
 </li>
 <li>
 Experience with regulatory document review/collection and knowledge of FDA and ICH GCP guidelines
 </li>
 <li>
 Experience with eTMF systems (e.g., Veeva Vault) and system administration skills
 </li>
 <li>
 Experience with Trial Master Files and centralized tracking systems
 </li>
 <li>
 Experience with IRB submissions and OHRP regulations is a plus
 </li>
 <li>
 Bachelor&rsquo;s degree required
 </li>
 <li>
 Strong organizational, communication, and time management skills
 </li>
 <li>
 Proficiency with Microsoft Office (Word, Excel, Outlook)
 
 
 </li>
 </ul>
 
 Compensation for In-House Clinical Research Associate includes:
 
 
 
 <ul>
 <li>
 Rate Range: $50,000&ndash;$80,000, depending on experience
 </li>
 <li>
 Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law
 
 
 </li>
 </ul>
 
 This job is open for applications on June 1st, 2026. Applications will be accepted at least 30 days from the posting date.
 
 
 
 Keywords: Clinical Research, Clinical Trials, Clinical Operations, In-House CRA, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Regulatory Affairs, Document Management, ICH GCP, FDA Regulations, Good Clinical Practice, Essential Documents, Site Document Collection, IRB Submissions, OHRP Regulations, Site Start-Up, Study Coordination, Clinical Study Support, Monitoring Support, TMF Maintenance, Document Tracking, Compliance, Audit Readiness, Clinical Data Management, Sponsor Oversight, CRO, Protocol Compliance, Investigator Communication, Site Management, Clinical Systems, Database Tracking, Microsoft Excel, Microsoft Word, Microsoft Outlook
 
 
</div>

In-House Clinical Research Associate

Warman O'Brien

<div>
 
 Clinical Research Associate II (CRA II) | North Carolina | Permanent | Hybrid
 
 
 
 
 
 I'm currently supporting a leading global biopharmaceutical organisation in the search for a Clinical Research Associate II to join their expanding Clinical Operations team.
 
 
 
 
 
 This is a fantastic opportunity for an experienced CRA looking to take the next step in their career with a company that is committed to advancing innovative therapies and improving patient outcomes worldwide.
 
 
 
 
 
 You'll be responsible for managing site monitoring activities across the full clinical trial lifecycle, working closely with investigators and study teams to ensure studies are delivered to the highest quality standards. The role offers excellent exposure, autonomy, and the chance to work within a highly collaborative and supportive environment.
 
 
 
 
 
 🔹 Independent site monitoring experience required
 
 
 🔹 Strong understanding of ICH-GCP and clinical trial regulations
 
 
 🔹 Opportunity to work on innovative clinical development programmes
 
 
 🔹 Excellent career progression and long-term development opportunities
 
 
 🔹 Competitive compensation, benefits, and supportive team culture
 
 
 
 
 
 If you're a CRA who enjoys site relationships, values quality, and wants to work within a supportive, collaborative environment where your contribution is recognised, this could be the move you've been waiting for.
 
 
 
 
 
 If you'd like to learn more, please send me a copy of your CV and I'll be in touch to arrange a confidential discussion.
 
</div>

Clinical Research Associate

ICON Strategic Solutions

<div>
 Clinical Research Associate - Early Development Multi Therapeutic - Midwest Region
 
 
 ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
 
 
 
 What You Will Be Doing
 
 
 
 <ul>
 <li>
 Serve as the primary point of contact between investigation sites and the sponsor
 </li>
 <li>
 Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
 </li>
 <li>
 Ensure site compliance with ICH-GCP, SOPs, and regulations
 </li>
 <li>
 Maintain up-to-date documentation in CTMS and eTMF systems
 </li>
 <li>
 Support and track site staff training and maintain compliance records
 </li>
 <li>
 Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
 </li>
 <li>
 Support subject recruitment and retention efforts at the site level
 </li>
 <li>
 Oversee drug accountability and ensure proper storage, return, or destruction
 </li>
 <li>
 Resolve data queries and drive timely, high-quality data entry
 </li>
 <li>
 Document site progress and escalate risks or issues to the clinical team
 </li>
 <li>
 Assist in tracking site budgets and ensuring timely site payments (as applicable)
 </li>
 <li>
 Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
 
 
 </li>
 </ul>
 
 You Are
 
 
 
 <ul>
 <li>
 A graduate with a Bachelor&rsquo;s degree in Life Sciences or equivalent, or a qualified RN
 </li>
 <li>
 Eligible to work in United States without visa sponsorship
 </li>
 <li>
 A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
 </li>
 <li>
 Experienced monitoring early development Phase I/II clinical studies, across multiple therapeutic areas
 </li>
 <li>
 Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
 </li>
 <li>
 A clear communicator, problem-solver, and collaborative team player
 </li>
 <li>
 Willing and able to travel up to 60% for on-site monitoring visits across the Midwest region; preference given to candidates residing in Midwest region near major HUB airports to support efficient regional travel
 
 
 </li>
 </ul>
 
 What ICON Can Offer You
 
 
 
 Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
 
 
 In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
 
 
 
 Our Benefits Examples Include
 
 
 
 <ul>
 <li>
 Various annual leave entitlements
 </li>
 <li>
 A range of health insurance offerings to suit you and your family&rsquo;s needs.
 </li>
 <li>
 Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
 </li>
 <li>
 Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family&rsquo;s well-being.
 </li>
 <li>
 Life assurance
 </li>
 <li>
 Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
 
 
 </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
 
 
 At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
 
 
 If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
 
 
 Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.
 
 
 Are you a current ICON Employee? Please click here to apply
</div>

AstraZeneca

<div>Location Michigan City, Indiana, United States Job ID R-254145 Date posted 08/06/2026</div>
 <div><div>Title: Clinical Research Associate
<ul><li>This role is located in either Ohio or Michigan</li></ul>
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the
individual studies.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager.
Accountabilities
<ul><li>Contributes to the selection of potential investigators.
</li><li>In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
</li><li>Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
</li><li>Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
</li><li>Actively participates in Local Study Team (LST) meetings.
</li><li>Contributes to National Investigators meetings, as applicable.
</li><li>Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
</li><li>Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
</li><li>Updates CTMS and other systems with data from study sites as per required timelines.
</li><li>Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
</li><li>Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits.
</li><li>Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
</li><li>Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
</li><li>Ensures data query resolution in a timely manner.
</li><li>Works with data management to ensure robust quality of the collected study data.
</li><li>Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
</li><li>Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP.
</li><li>Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
</li><li>Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
</li><li>Assists site in maintaining inspection ready ISF.
</li><li>Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
</li><li>Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate.
</li><li>Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF.
</li><li>Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
</li><li>Ensures compliance with AstraZeneca&rsquo;s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
</li><li>Ensures compliance with local, national and regional legislation, as applicable.
</li><li>Collaborates with local MSLs as directed by LSM or line manager.
</li></ul>Requirements:
<ul><li>Bachelors degree in related discipline, preferably in life science, or equivalent qualification (*).
</li><li>Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
</li><li>Good knowledge of relevant local regulations.
</li><li>Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
</li><li>Basic understanding of the drug development process.
</li><li>Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
</li><li>Excellent attention to details.
</li><li>Good written and verbal communication skills.
</li><li>Good collaboration and interpersonal skills.
</li><li>Good negotiation skills.
</li><li>Ability to travel nationally/internationally as required.
</li><li>Valid driving license
</li></ul>The annual base pay for this position ranges from $112,154.40 - $168,231.60. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an &ldquo;at-will position&rdquo; and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
09-Jun-2026
Closing Date
19-Jun-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.</div></div><div></div>

Clinical Research Associate - Ohio/Michigan

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation 
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.<div>
Must have at least 1 year of travel monitoring experience in Neurology!
 
 
As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. 
 
What You&rsquo;ll Do: 
<ul><li>Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</li><li>Participates in investigator meetings as necessary. Identifies potential</li><li>investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</li><li>Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.</li><li>Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>Responds to company, client and applicable regulatory requirements/audits/inspections.</li><li>Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</li><li>Contributes to other project work and initiatives for process improvement, as required.</li></ul> 
Education and Experience Requirements: 
<ul><li>Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.</li><li>Valid driver's license where applicable.</li></ul>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 
 
Knowledge, Skills and Abilities: 
<ul><li>Proven clinical monitoring skills</li><li>Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</li><li>Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving</li><li>Ability to manage Risk Based Monitoring concepts and processes</li><li>Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>Good organizational and time management skills</li><li>Effective interpersonal skills</li><li>Attention to detail</li><li>Ability to remain flexibile and adaptable in a wide range of scenarios</li><li>Ability to work in a team or independently as required</li><li>Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>Good English language and grammar skills</li><li>Good presentation skills</li></ul> 
Working Conditions and Environment: 
<ul><li>Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.</li><li>Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.</li><li>Exposure to biological fluids with potential exposure to infectious organisms.</li><li>Personal protective equipment required such as protective eyewear, garments and gloves.</li><li>Exposure to fluctuating and/or extreme temperatures on rare occasions</li></ul></div></div>

Clinical Research Associate II/ Neurology/ Eastern region of the US!

Advanced Research Institute

Job Description Summary: The Clinical Research Coordinator (CRC) works under the direction of company administration and the principle investigator to perform assigned and delegated duties associated with the execution of clinical research trial protocols. The Clinical Research Coordinator will have, or will develop, skills in phlebotomy, electrocardiograms, collection of medical/surgical histories, basic laboratory tests, performance of subject trial visits, completion of case report forms (CRFs), and resolution of data queries. The Clinical Research Coordinator will participate in the completion of regulatory documents. The Clinical Research Coordinator shall have the highest moral and ethical standards and will be expected to conduct themselves in a responsible, professional, moral, and ethical manner at all times. The Clinical Research Coordinator shall have excellent interpersonal communication skills and have a strong commitment to the success of the research team.CRC Responsibilities:- Assist in the coordination and execution of clinical drug trials under the guidance and direction of the site administrator, principal investigator, and sub-investigators.- Read, comprehend, and execute clinical trial protocols.- Perform laboratory tests as required by trial protocol.- Monitor clinical and laboratory data for accuracy and compliance with trial protocols.- Complete all documentation required by trial protocol for submission to the trial sponsor.- Comply with all international, federal, state, local, and company guidance, laws, regulations, policies, and procedures as applicable to clinical research trials and Advanced Research Institute.- Interact with patients by explaining trial protocols, consenting subjects, monitoring their compliance with protocols, collecting data, and collection laboratory samples.- Protect every subject's safety to the best of your ability.- Maintain every patient's rights to privacy.- Maintain flexibility by performing all other assigned duties.-Perform phlebotomy. (Phlebotomist.)Training: On the job training. Formal continuing education opportunities provided.Experience Requirements: Experience is highly preferred but not necessarily required.Education Requirements: High school diploma required.Job Type: Full-timeSchedule:<ul><li>8 hour shift</li><li>Monday to Friday</li><li>No weekends</li></ul>Ability to commute/relocate:<ul><li>Tigard, OR 97223: Reliably commute or planning to relocate before starting work (Required)</li></ul>Education:<ul><li>High school or equivalent (Required)</li></ul>Experience:<ul><li>Research: 1 year (Preferred)</li><li>Clinical trials: 1 year (Preferred)</li><li>Phlebotomy: 1 year (Preferred)</li></ul>Work Location: In personJob Type: Full-timePay: $22.00 - $27.00 per hourBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Flexible spending account</li><li>Health insurance</li><li>Paid time off</li></ul>Ability to Commute:<ul><li>Portland, OR 97223 (Required)</li></ul>Work Location: In person

Clinical Research Coordinator

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4146 clinical trial associate jobs Near Me

In-House Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate - Ohio/Michigan

Clinical Research Associate II/ Neurology/ Eastern region of the US!

Clinical Research Associate II/ Neurology/ Eastern region of the US!

Clinical Research Coordinator