clinical research management 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

Syneos Health

<div>Clinical Research Associate - Full-Service
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
</li><li>We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.
</li></ul>Job Responsibilities
<ul><li>Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
</li><li>Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
</li><li>Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.
</li><li>May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
</li><li>Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
</li><li>Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
</li><li>For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
</li><li>May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
</li><li>Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
</li><li>Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
</li><li>Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection
 
Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.
</li></ul>Qualifications:
<ul><li>Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience
</li><li>Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
</li><li>Must demonstrate good computer skills and be able to embrace new technologies
</li><li>Excellent communication, presentation and interpersonal skills
</li><li>Ability to manage required travel of up to 75% on a regular basis
</li><li>US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.
</li></ul>We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</div>

Clinical Research Associate - Full-Service

AbbVie

<div>
 
 Company Description
 
 
 
 
 About AbbVie
 
 
 
 AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
 
 
 
 Job Description
 
 
 
 
 We are hiring in Pittsburg &amp; Michigan
 
 
 
 Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
 
 
 Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
 
 
 Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
 
 
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.
 </li>
 <li>
 Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
 </li>
 <li>
 Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
 </li>
 <li>
 Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
 </li>
 <li>
 Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
 </li>
 <li>
 Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
 </li>
 <li>
 Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
 </li>
 <li>
 Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
 </li>
 <li>
 Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
 </li>
 <li>
 Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
 </li>
 <li>
 Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk&hyphen;based monitoring approach, onsite and offsite monitoring.
 </li>
 <li>
 Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
 </li>
 <li>
 Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
 </li>
 <li>
 Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
 </li>
 <li>
 Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
 </li>
 <li>
 Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
 </li>
 <li>
 Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
 </li>
 <li>
 Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
 </li>
 <li>
 Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.
 
 
 </li>
 </ul>
 Additional Information
 
 
 Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
 
 
 <ul>
 <li>
 The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
 </li>
 <li>
 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
 </li>
 <li>
 This job is eligible to participate in our short-term incentive programs.
 
 
 </li>
 </ul>
 Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolutediscretion, consistent with applicable law.
 
 
 AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
 
 
 US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
 
 
 US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
 
 
 https://www.abbvie.com/join-us/reasonable-accommodations.html
</div>

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

<div>Company Description 
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
This position will be field based in Central Florida
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. 
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. 
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities<ul><li>
Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.</li><li>
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.</li><li>
Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li><li>
Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li><li>
Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. 
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li><li>
Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. 
May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li><li>
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.</li><li>
Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li><li>
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li><li>
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. 
Ensures audit and regulatory inspection readiness at assigned clinical site at all times. 
Manages investigator payments as per executed contract obligations, as applicable.</li></ul> 

Qualifications 
<ul><li>
Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.</li><li>
Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li><li>
Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li><li>
Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.</li><li>
Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolutediscretion, consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Clinical Research Associate II

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

Search 10000+ Clinical research management associate jobs near you this June. New roles added regularly across leading industries. Apply today.

10000 clinical research management associate jobs Near Me

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate - Ohio/Michigan

Clinical Research Associate - Full-Service

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

Clinical Research Associate II

In-House Clinical Research Associate