senior cra

Medasource

<div>
 
 
 Position Overview
 
 
 
 
 Pay:
 
 $70-75 an hour | 40 hour work week
 
 
 
 
 
 The Senior Clinical Research Associate (CRA) will serve as the
 
 primary owner for assigned clinical sites
 
 , overseeing day-to-day site management, monitoring activities, and issue resolution for cardiovascular device studies involving heart pump technology.
 
 
 
 
 
 This role requires a
 
 traditional, hands-on monitoring approach
 
 , including in-depth review of medical records, informed consent documentation, and safety data. The CRA is expected to independently identify risks, guide sites through corrective actions, and escalate thoughtfully when necessary.
 
 
 
 
 
 
 CRA's will be involved cardiovascular studies. Devices which are used in various cardiac procedures.
 
 
 
 
 
 
 
 Key Responsibilities
 
 
 
 1. Site Management &amp; Ownership
 
 <ul>
 <li>
 Serve as the
 
 primary point of contact
 
 for assigned investigational sites
 </li>
 <li>
 Take full ownership of site performance, beyond high-level monitoring
 </li>
 <li>
 Proactively manage:
 </li>
 <li>
 Site questions and protocol clarifications
 </li>
 <li>
 Retraining needs
 </li>
 <li>
 Data quality concerns
 </li>
 <li>
 Monitoring follow-ups
 </li>
 <li>
 Identify issues early and work independently to resolve them before escalating
 </li>
 </ul>
 
 
 
 
 2. Clinical Monitoring (SDV &amp; SDR)
 
 <ul>
 <li>
 Conduct onsite monitoring visits focused on
 
 deep Source Data Verification (SDV)
 
 and
 
 Source Data Review (SDR)
 
 </li>
 <li>
 Review
 
 full medical records
 
 , not just EDC worksheets
 </li>
 <li>
 Ensure:
 </li>
 <li>
 Accurate transcription of source data
 </li>
 <li>
 Protocol compliance
 </li>
 <li>
 Complete and compliant documentation
 </li>
 <li>
 Clearly articulate monitoring logic, including:
 </li>
 <li>
 How informed consent is reviewed
 </li>
 <li>
 How eligibility and endpoint data are verified
 </li>
 </ul>
 
 
 
 
 3. Protocol Compliance &amp; Patient Safety
 
 <ul>
 <li>
 Act as the
 
 first line of defense
 
 to ensure sites:
 </li>
 <li>
 Enroll the correct patient populations
 </li>
 <li>
 Follow protocol requirements precisely
 </li>
 <li>
 Review medical histories and clinical documentation to identify:
 </li>
 <li>
 Adverse events (AEs)
 </li>
 <li>
 Serious adverse events (SAEs)
 </li>
 <li>
 Other safety signals
 </li>
 <li>
 Assist sites in properly documenting and reporting safety events in accordance with protocol and regulatory expectations
 </li>
 </ul>
 
 
 
 
 4. Communication &amp; Team Integration
 
 <ul>
 <li>
 Participate in:
 </li>
 <li>
 Regular study team meetings
 </li>
 <li>
 Project check-ins and updates
 </li>
 <li>
 Maintain
 
 high transparency
 
 by:
 </li>
 <li>
 Copying the internal study team on all site-related communications
 </li>
 <li>
 Providing clear, timely updates on site status, risks, and progress
 </li>
 <li>
 Operate as an embedded team member rather than a siloed monitor
 </li>
 </ul>
 
 
 
 
 5. Office-Based Administrative Responsibilities
 
 
 Approximately
 
 1&ndash;2 weeks per month
 
 are dedicated to office-based work, including:
 
 <ul>
 <li>
 Query review and resolution
 </li>
 <li>
 Site retraining preparation and follow-up
 </li>
 <li>
 Monitoring visit preparation and documentation
 </li>
 <li>
 Follow-up on action items identified during visits
 </li>
 <li>
 Ongoing site relationship management
 </li>
 </ul>
 
 This time is critical to maintaining site quality and continuity between visits.
 
 
 
 
 
 
 Qualifications &amp; Experience
 
 
 
 Required Experience
 
 <ul>
 <li>
 
 5&ndash;10 years
 
 of clinical monitoring experience
 </li>
 <li>
 Previous experience functioning at a
 
 Senior CRA level
 
 </li>
 <li>
 Strong background in
 
 cardiovascular clinical studies
 
 </li>
 </ul>
 
 
 
 
 Preferred Experience
 
 <ul>
 <li>
 
 Medical device trial experience
 
 (highly preferred)
 </li>
 <li>
 Understanding of device-specific regulatory and procedural nuances
 </li>
 <li>
 Experience working:
 </li>
 <li>
 Directly with a sponsor
 
 or
 
 </li>
 <li>
 At a smaller, high-touch CRO
 </li>
 <li>
 Candidates whose background is limited to large, highly automated CRO environments may not be an ideal fit due to differences in monitoring depth and expectations
 </li>
 <li>
 Someone who has worked with us in the past.
 </li>
 </ul>
 
 
 
 
 Core Competencies
 
 <ul>
 <li>
 Strong critical-thinking and problem-solving skills
 </li>
 <li>
 Ability to clearly explain:
 </li>
 <li>
 SDV/SDR methodology
 </li>
 <li>
 Informed consent review process
 </li>
 <li>
 Safety event identification
 </li>
 <li>
 High attention to detail with a patient-safety mindset
 </li>
 <li>
 Strong written and verbal communication skills
 </li>
 <li>
 Comfort operating autonomously with accountability
 </li>
 </ul>
 
 
 
 
 
 Travel &amp; Work Environment
 
 
 <ul>
 <li>
 
 Travel Requirement:
 
 Approximately
 
 60%
 
 </li>
 <li>
 
 Visit Frequency:
 
 </li>
 <li>
 Typically
 
 2 monitoring visits per month
 
 </li>
 <li>
 Occasionally
 
 3 visits per month
 
 </li>
 <li>
 Only
 
 one visit in any given week
 
 </li>
 <li>
 
 Geographic Scope:
 
 </li>
 <li>
 Primary regions include East Coast, South, and Midwest
 </li>
 <li>
 Some sites located in
 
 California and Texas
 
 </li>
 <li>
 Willingness to travel outside a traditional region as business needs arise is required
 </li>
 </ul>
 
 
 
 
 
 Travel &amp; Expense Logistics
 
 
 <ul>
 <li>
 Travel is booked through the
 
 Concur
 
 system
 </li>
 <li>
 CRA uses a
 
 personal credit card
 
 to access preferred corporate rates
 </li>
 </ul>
 
 
</div>

Clinical Research Associate

IQVIA

<div>Istanbul, Turkey | Full time | Home-based | R1535388</div>
 <div><div>To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.</div><div>
Responsabilities:</div><ul><li>
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.</li><li>
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies</li><li>
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.</li><li>
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.</li><li>
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.</li><li>
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.</li><li>
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.</li><li>
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.</li><li>
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.</li><li>
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.</li><li>
Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).</li><li>
Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.</li><li>
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.</li><li>
Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.</li><li>
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.</li><li>
Proactively identifies risks and facilitates resolution of complex study problems and issues.</li><li>
Organises regular Local Study Team meetings on an agenda driven basis.</li><li>
Actively works towards achieving good personal relationships with all Local Study Team members, sites&rsquo; staff and global stakeholders.</li><li>
Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.</li><li>
Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.</li><li>
Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.</li><li>
Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.</li><li>
Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.</li><li>
Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.</li><li>
Provides input to process development and improvement.</li><li>
Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.</li><li>
Updates Line Managers about the performance of the CRAs/CSAs.</li><li>
Ensures that study activities at country level comply with local policies and code of ethics.</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 Sponsor&acute;s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).</li><li>
Collaborates with local Medical Affairs team.</li><li>
Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.</li></ul><div>
Requirements:</div><ul><li>
Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).</li><li>
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).</li><li>
Good knowledge of international guidelines ICH GCP as well as relevant local regulations.</li><li>
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.</li><li>
Good medical knowledge and ability to learn relevant Sponsor Therapeutic Areas</li><li>
Good knowledge of the Drug Development Process.</li><li>
Excellent understanding of the Clinical Study Process including monitoring.</li><li>
Very good understanding of the Study Drug Handling Process and the Data Management Process.</li><li>
Excellent project management skills.</li><li>
Excellent team building and interpersonal skills, organizational skill and verbal and written communication skills</li><li>
Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.</li><li>
Excellent knowledge of spoken and written English and local languages.</li><li>
Good ability to learn and to adapt to work with IT systems.</li><li>
Ability to travel nationally and internationally as required</li></ul><div>
&quot;Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered&rdquo;.</div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div>

Local Study Associate Director - Sponsor Dedicated (m/w/d)

JPMorganChase

<div>JOB DESCRIPTION 
To fulfill the firm&rsquo;s CRA obligations, CRCP maintains a technology platform which includes a data ecosystem that assembles qualifying activities from across the firm and from external data sources, workflow tools to manage review of those activities, and operational tools to facilitate LOB engagement, strategy, and other CRCP deliverables.
The Program Manager for the CRA Program is responsible for translating CRCP&rsquo;s business requirements into actionable technical solutions &ndash; a combination of steady-state technology deliverables and ground-breaking new development leveraging AI and re-architected technology. This role serves as the primary liaison between CRCP teams, and Corporate Technology Product and Engineering, ensuring that CRA-related technology initiatives are delivered efficiently, accurately, and in compliance with CRA requirements and business standards. The Program Manager gathers proposed prioritization of technology work and is responsible for stakeholder collaboration, requirements management, testing oversight/acceptance.
The ideal candidate will demonstrate strong analytical and communication skills, a deep understanding of agile methodologies and product management, as well as the ability to work collaboratively across business, Product and Technology. They will be proactive in identifying and resolving issues, adept at managing competing priorities, and committed to delivering high-quality solutions that support regulatory requirements and operational excellence.
Responsibilities:<ul><li>
Serve as the primary liaison between CRCP and the Technical Product Manager, ensuring clear and consistent communication of priorities and objectives.</li><li>
Assist with documenting CRCP&rsquo;s technical needs by working closely with stakeholders.</li><li>
Maintain and manage a clear, organized, and prioritized backlog of CRA-related technical needs, ensuring alignment with business goals and regulatory deadlines.</li><li>
Collaborate with the Technical Product Owner to oversee the timely delivery of technology solutions that effectively address CRA business objectives and operational needs.</li><li>
Participate actively in agile ceremonies, including sprint planning and backlog grooming, to represent CRA priorities and ensure business needs are reflected in development activities.</li><li>
Coordinate user acceptance testing (UAT) to assist CRCP with validation of technology solutions.</li><li>
Provide structured feedback to Product and Technology based on testing and user experience and drive continuous improvement of CRA technology solutions.</li></ul>
Qualifications<ul><li>
3+ years of experience in product ownership required, with business analysis and project management, preferably within financial services or regulatory environments, strongly preferred.</li><li>
Familiarity with agile methodologies and product management tools strongly preferred.</li><li>
Understanding of the Community Reinvestment Act and related compliance requirements.</li><li>
Experience working with cross-functional teams, including business, Product and Technology.</li><li>
Excellent communication, documentation, and organizational skills.</li><li>
Familiarity with agile methodologies and product management tools strongly preferred.
</li><li>Bachelor&rsquo;s degree in Information Systems, Business, Finance, or related field is preferred.</li></ul>
ABOUT US 
<div>
<div>JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world&rsquo;s most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.
</div><div>We offer a competitive total rewards package including base salary determined based on the role, experience, skill set and location. Those in eligible roles may receive commission-based pay and/or discretionary incentive compensation, paid in the form of cash and/or forfeitable equity, awarded in recognition of individual achievements and contributions. We also offer a range of benefits and programs to meet employee needs, based on eligibility. These benefits include comprehensive health care coverage, on-site health and wellness centers, a retirement savings plan, backup childcare, tuition reimbursement, mental health support, financial coaching and more. Additional details about total compensation and benefits will be provided during the hiring process.
<div>We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants&rsquo; and employees&rsquo; religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation.
JPMorgan Chase &amp; Co. is an Equal Opportunity Employer, including Disability/Veterans 
</div></div></div> 
 
ABOUT THE TEAM 
<div>Our professionals in our Corporate Functions cover a diverse range of areas from finance and risk to human resources and marketing. Our corporate teams are an essential part of our company, ensuring that we&rsquo;re setting our businesses, clients, customers and employees up for success. 
</div><div></div> 
<div>The Corporate Responsibility (CR) department mission is to advance a stronger, more durable and safe financial system and an inclusive economy and society for clients, customers and communities around the world. The department includes sub-departments focused on policy advocacy and lobbying, philanthropy, sustainability, impact finance, community engagement and data analysis and research.</div></div>

Community Reinvestment Act Program Manager

Medpace

<div>
 
 Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!
 
 
 
 This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our
 
 PACE&reg;
 
 Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
 
 
 
 WE OFFER THE FOLLOWING
 
 
 
 <ul>
 <li>
 Competitive travel bonus;
 </li>
 <li>
 Equity/Stock Option program;
 </li>
 <li>
 Training completion and retention bonus
 </li>
 <li>
 Annual merit increases;
 </li>
 <li>
 401K matching;
 </li>
 <li>
 The opportunity to work from home;
 </li>
 <li>
 Flexible work hours across days within a week;
 </li>
 <li>
 Retain airline reward miles and hotel reward points;
 </li>
 <li>
 Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
 </li>
 <li>
 In-house travel agents, reimbursement for airline club, and TSA pre-check;
 </li>
 <li>
 Opportunity for leadership positions &ndash; Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
 </li>
 <li>
 CRA training program (PACE&reg;);
 </li>
 <li>
 Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
 </li>
 <li>
 In-house administrative support for all levels of CRAs; and
 </li>
 <li>
 Opportunities to work with international team of CRAs.
 
 
 </li>
 </ul>
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
 </li>
 <li>
 Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
 </li>
 <li>
 Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
 </li>
 <li>
 Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
 </li>
 <li>
 On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
 </li>
 <li>
 Verification that the investigator is enrolling only eligible subjects;
 </li>
 <li>
 Regulatory document review;
 </li>
 <li>
 Medical device and/or investigational product/drug accountability and inventory;
 </li>
 <li>
 Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
 </li>
 <li>
 Assess the clinical research site&rsquo;s patient recruitment and retention success and offering suggestions for improvement; and
 </li>
 <li>
 Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Must have a minimum of a Bachelor&rsquo;s degree in a health or science related field;
 </li>
 <li>
 Experience as a Clinical Research Coordinator (minimum 1 year);
 </li>
 <li>
 Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely
 </li>
 <li>
 Must maintain a valid driver&rsquo;s license and the ability to drive to monitoring sites;
 </li>
 <li>
 Proficient knowledge of Microsoft&reg; Office;
 </li>
 <li>
 Strong communication and presentation skills; and
 </li>
 <li>
 Must be detail-oriented and efficient in time management.
 
 
 </li>
 </ul>
 
 
 
 
 
 Medpace Overview
 
 
 
 Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
 
 
 
 Why Medpace?
 
 
 
 People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
 
 
 The work we&rsquo;ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
 
 
 
 Medpace Perks
 
 
 
 <ul>
 <li>
 Flexible work environment
 </li>
 <li>
 Competitive PTO packages &ndash; starting at 20+ days
 </li>
 <li>
 Company-sponsored employee appreciation events
 </li>
 <li>
 Employee health and wellness initiatives
 </li>
 <li>
 Competitive compensation and benefits package
 </li>
 <li>
 Structured career paths with opportunities for professional growth
 </li>
 <li>
 Discounts for local businesses
 
 
 </li>
 </ul>
 
 Awards
 
 
 
 <ul>
 <li>
 Named a Top Workplace in 2024 by The Cincinnati Enquirer
 </li>
 <li>
 Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
 </li>
 <li>
 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
 
 
 </li>
 </ul>
 
 What To Expect Next
 
 
 
 A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
 
 
</div>

Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

<div>
 
 
 IQVIA Biotech is now hiring for CRA 1 with a minimum of 6 months of on-site monitoring. Must have experience monitoring in oncology solid tumor.
 
 
 
 
 
 IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.
 
 
 
 
 Job Overview
 
 
 
 The Clinical Research Associate I (CRA I) plays a key role in supporting the successful conduct of clinical research studies by performing site monitoring and site management activities. In this position, you will ensure that assigned study sites conduct trials in compliance with the protocol, applicable regulations, Good Clinical Practice (GCP), and ICH guidelines. This role is essential in protecting patient safety, ensuring high‑quality clinical data, and maintaining study integrity.
 
 
 
 Key Responsibilities
 
 
 
 As a CRA I, you will conduct various types of monitoring visits&mdash;including site selection, initiation, routine monitoring, and close‑out visits&mdash;to evaluate the quality and integrity of site practices. You will verify that study activities are performed according to regulatory requirements and sponsor expectations, escalating quality concerns as necessary. During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the Investigator Site File (ISF).
 
 
 A central part of this role involves building and maintaining strong communication with investigative sites. You will provide protocol training, set expectations, address site‑level challenges, and support recruitment planning to help sites meet enrollment targets. You will also collaborate closely with internal project teams to ensure cohesive study execution and may contribute to site-level financial processes or start‑up activities based on study needs.
 
 
 Accurate and timely documentation is critical. The CRA I prepare detailed monitoring visit reports, follow‑up letters, and all required study documentation to ensure audit readiness and transparent oversight. The ability to manage multiple tasks, prioritize effectively, and work independently while maintaining productive team relationships is essential for success.
 
 
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree required; a scientific or healthcare discipline is preferred.
 </li>
 <li>
 6 months &ndash;2 years of relevant experience, with equivalent combinations of education, training, or completion of a CRA training program considered.
 </li>
 <li>
 Basic knowledge of clinical research regulations (GCP/ICH).
 </li>
 <li>
 Ability to travel as required by the project.
 
 
 </li>
 </ul>
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
 
 
 IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
 
 
 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
 
 
 The potential base pay range for this role, when annualized, is $71,900.00 - $119,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
</div>

CRA 1, IQVIA Biotech

Planet Pharma

<div>
 
 
 Role Purpose
 
 
 
 Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
 
 
 
 Essential Job Functions
 
 
 
 Provide cross functional operational support throughout the study lifecycle, investigating data or documentation discrepancies and contributing to process improvements that reduce recurrence during study conduct and closeout
 
 
 Support and coordinate study start up activities, including tracking site readiness, managing essential document collection, and communicating with sites regarding planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs).
 
 
 Perform remote monitoring visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study monitoring plan
 
 
 Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel
 
 
 Build and maintain strong working relationships with internal partners (Clinical Operations, Regulatory Affairs, Quality, R&amp;D) and site personnel (Investigators, CRCs, research nurses) to support enrollment, data quality, and site performance.
 
 
 Assist with any site remediation activities, as applicable
 
 
 Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training
 
 
 Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas
 
 
 
 Required
 
 
 
 Bachelor's Degree or Equivalent Life Sciences or Nursing
 
 
 3-4 years in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry
 
 
 Experience with electronic data capture.
 
 
 
 Preferred
 
 
 
 Licenses and Certifications: Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)
 
</div>

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8697 senior cra jobs Near Me

Clinical Research Associate

Local Study Associate Director - Sponsor Dedicated (m/w/d)

Community Reinvestment Act Program Manager

Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

CRA 1, IQVIA Biotech

CRA 1, IQVIA Biotech

Clinical Research Associate