clinical monitor

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

Indero

Freelance / Contractual CRA with experience in Dermatology, Florida
 
The Contractual Clinical Research Associate (cCRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
 
This role will be perfect for you if: 
You are an experienced CRA with a demonstrated ability to work autonomously to meet quality standards and deadlines
 Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you
 You enjoy working for a mid-sized CRO where your contributions are noticed and valued
 
RESPONSIBILITIES
 
The cCRA will: 
Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Indero and sponsor SOPs, ICH/CGP guidelines and applicable regulations
 Participates in investigators’ meetings
 Prepares site visit reports and follow-up letters to the investigator
 Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets
 Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate
 Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training
 
Requirements: 
Education
 
B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
 
Experience
 
3 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
 At least 1 year of experience in dermatology
 
Knowledge and skills
 
Good knowledge of ICH/GCP standards and applicable regulatory requirements
 Strong verbal and written communication skills in English
 Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
 Excellent judgement and problem-solving skills
 Travel to research sites approximately 65% of the time
 Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)
 Experience in dermatology is an asset
 
Brand name: 
Indero
 
Our company: 
The work environment
 
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
 
Recruitment process: what to expect
 
As part of the recruitment process for this position you will meet various team members at Indero
 The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour)
 
About Indero
 
A Global Clinical Leader In Dermatology!
 
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
 
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
 
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
 
Indero only accepts applicants who can legally work in the United State.

Freelance, Senior Clinical Research Associate or CRA II, Florida, USA

Fortrea

<div>Our FSP team is currently seeking an Oncology Sr. CRA 2 with 5+ years of monitoring residing in the Los Angeles or Southern California.
WHAT YOU WILL DO
You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Responsibilities:<ul><li>
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -</li><li>
Responsible for all aspects of site management as prescribed in the project plans</li><li>
General On-Site Monitoring</li><li>
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</li><li>
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</li><li>
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data</li><li>
Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested</li><li>
Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs</li><li>
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management</li><li>
Assist with training of new employees, eg. co-monitoring</li><li>
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned</li><li>
Perform other duties as assigned by management</li></ul>
Requirements<ul><li>
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)</li><li>
5+ years of Clinical Monitoring experience</li><li>
Oncology experience, early phase preferred</li><li>
40-50% overnight travel</li></ul>
The important thing for us is you are comfortable working in an environment that is:<ul><li>
Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.</li><li>
Changing priorities constantly asking you to prioritize and adapt on the spot.</li><li>
Teamwork and people skills are essential for the study to run smoothly.</li><li>
Technology based. We collect our data directly into an electronic environment.</li></ul>
Work Environment:<ul><li>
Work is performed in an office environment with exposure to electrical office equipment.</li><li>
Frequent travel to clients/ site locations with occasional travel both domestic and international.</li></ul>
Physical Requirements:<ul><li>
Ability to sit for extended periods and operate a vehicle safely.</li><li>
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</li><li>
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</li><li>
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</li><li>
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</li><li>
Regular and consistent attendance.</li><li>
Varied hours may be required.</li><li>
Target Pay Range: $125 - $140K</li></ul>
#LI - Remote
Applications will be accepted on an ongoing basis.
Learn more about our EEO &amp; Accommodations request here.</div>

Sr. CRA II, Oncology, FSP - Los Angeles

<div>Our FSP team is currently seeking an Oncology Sr. CRA 2 with 5+ years of monitoring residing in the NYC Metro.
WHAT YOU WILL DO
You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Responsibilities:<ul><li>
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -</li><li>
Responsible for all aspects of site management as prescribed in the project plans</li><li>
General On-Site Monitoring</li><li>
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</li><li>
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</li><li>
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data</li><li>
Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested</li><li>
Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs</li><li>
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management</li><li>
Assist with training of new employees, eg. co-monitoring</li><li>
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned</li><li>
Perform other duties as assigned by management</li></ul>
Requirements<ul><li>
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)</li><li>
5+ years of Clinical Monitoring experience</li><li>
Oncology experience, early phase preferred</li><li>
40-50% overnight travel</li></ul>
The important thing for us is you are comfortable working in an environment that is:<ul><li>
Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.</li><li>
Changing priorities constantly asking you to prioritize and adapt on the spot.</li><li>
Teamwork and people skills are essential for the study to run smoothly.</li><li>
Technology based. We collect our data directly into an electronic environment.</li></ul>
Work Environment:<ul><li>
Work is performed in an office environment with exposure to electrical office equipment.</li><li>
Frequent travel to clients/ site locations with occasional travel both domestic and international.</li></ul>
Physical Requirements:<ul><li>
Ability to sit for extended periods and operate a vehicle safely.</li><li>
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</li><li>
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</li><li>
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</li><li>
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</li><li>
Regular and consistent attendance.</li><li>
Varied hours may be required.</li><li>
Target Pay Range: $125 - $140K</li></ul>
#LI - Remote
Applications will be accepted on an ongoing basis.
Learn more about our EEO &amp; Accommodations request here.</div>

Sr. CRA II - Oncology, FSP - NYC

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. 
 
 
 
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>
Compensation and Benefits
The salary range estimated for this position based in New York is $100,000.00&ndash;$140,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>
A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>
Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</li><li>
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>
Employees&rsquo; Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards</div>

Clinical Research Associate (Level II) - FSP Oncology- NortheastUS

<div>Job ID R-541838 Date posted 13 April 2026
<div><h1 class="jobSectionHeader">Job Description Summary</h1>
The Senior Clinical Research Associate is responsible for delivering high quality and compliant site management &amp; monitoring for clinical studies (e.g., EFS/FIH, IDE, Post-Market) sponsored by the BD Peripheral Intervention business unit to ensure they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations. The Senior Clinical Research Associate will be responsible for the day-to-day management and oversight of assigned clinical sites, performing on-site and remote monitoring visits, driving recruitment, providing technical/troubleshooting support and for developing strong relationships with clinical site personnel including Investigators, study coordinators, nurses and other site staff. The Senior Clinical Research Associate will also lead and/or support Clinical Project Management with other study development, study start-up, study conduct/maintenance and study close-out activities including the review and development of essential clinical study documents. 
 
 
 
 
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.<h1 class="jobSectionHeader">
Job Description</h1>
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health&trade; is our Purpose, and it&rsquo;s no small feat. It takes the imagination and passion of all of us&mdash;from design and engineering to the manufacturing and marketing of our billions of MedTech products per year&mdash;to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you&rsquo;ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Job Responsibilities:<div><ul><li>
Provide Site Management &amp; Monitoring support for BDPI clinical studies to enable successful completion of studyobjectivesand deliverables.</li></ul></div><div><ul><li>
Ensure quality and compliance for assigned clinical studies and study activities performed at assigned clinical sites, ensuring the highest standards for scientific quality, integrity and ethics are met and that these are conducted according to BD global clinical procedures, study protocols, GCP and all applicable regulations.</li></ul></div><div><ul><li>
Conduct on-site or remote clinical site monitoring activities for assigned clinical sites to evaluate sites for qualification or activation, review informed consent forms, review subject data for accuracy, issue and address data queries, ensure study is conducted compliantly, address/escalate study non-compliance issues, verify that any corrective actions are implemented, perform investigational clinical product accountability, ensure proper regulatory approval, review essential clinical study documents for completion/accuracy, conduct study training/presentations, ensure proper training documentation, ensure timely reporting for reportable events (e.g., Unanticipated Adverse Device Effects, device deficiencies, etc.), ensure good documentation/clinical practices (GDP/GCP), ensure study supplies are adequate and perform other site management &amp; monitoring activities, as needed.</li></ul></div><div><ul><li>
Serve as a product, procedure and clinical study protocol expert and resource for BD stakeholders, Investigators, and study site personnel.</li></ul></div><div><ul><li>
Develop andmaintainstrong relationships with investigational site staff, hospital personnel, and cross-functional study teams to support study deliverables. Facilitate communication between clinical sites and BD stakeholders (e.g., PMs, Clinical Field Specialists, Contract Managers), as needed.</li></ul></div><div><ul><li>
Develop and manage study-specific tracking reports to detail clinical study progress (e.g., screening/enrollment status, site activation status, SDV status, etc.), as required, to ensure Site Management &amp; Monitoring deliverables are completed compliantly, within study-specific timelines and within budgets for clinical studies and/or sites assigned.</li></ul></div><div><ul><li>
Perform study and/or site-level audits of the Trial Master File (TMF) for accuracy, that files are current, completeand audit-ready.</li></ul></div><div><ul><li>
Assistwith study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current,accurateand complete.</li></ul></div><div><ul><li>
Develop and/or complete study-specific reports such as: Clinical Site Activation Checklists, Master Site Selection Trackers, Qualification Visit Reports, Initiation Visit Reports, Interim Monitoring Visit Reports, Close-Out Visit Reports, Confirmation &amp; Follow-Up Letters, Clinical Site Product Accountability Logs, Clinical Site Training Logs, Clinical Site Visit Logs, Delegation of Authority Logs, Clinical Monitoring Plans, Financial Disclosure Forms and other essential clinical study documents.</li></ul></div><div><ul><li>
Review and provide input on the development of other essential documents related to Clinical Project Management, Clinical Data Management, Clinical Statistics, Clinical Safety Management, Clinical Product Management and Clinical Supplier Management.</li></ul></div><div><ul><li>
Proactively and critically examine ways to enhance overall clinical study performance and transfer clinical study knowledge and experience into meaningful input and feedback to cross-functional study team partners within Clinical Affairs.</li></ul></div><div><ul><li>
Communicate BD product complaints and other events/issues that inhibit safe and effective use of BD products and negativelyimpactsubject recruitment, datacollectionand study performance to BD stakeholdersin accordance withestablished clinical study procedures and company policies.</li></ul></div><div><ul><li>
Participate in, support and/or lead study-specific meetings including, but not limited to study team meetings, Clinical Research Associate team meetings, and vendor meetings.</li></ul></div><div><ul><li>
Support Clinical Project Management with other administrative tasks, as needed, tofacilitatethe conduct of the study.</li></ul></div><div><ul><li>
Provide critical thinking and support for issue escalation related to site management &amp; monitoring. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactively identify issues and build mitigation strategies in collaboration with clinical trial leadership and other management.
</li></ul></div><div><ul><li>Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to site management &amp; monitoring activities.</li></ul></div><div><ul><li>
Support continuous improvement activities/initiatives and sharing of best practices, including development of site management &amp; monitoring tools and resources.</li></ul></div><div><ul><li>
Mentor Site Management &amp; Monitoring personnel and conduct monitoring evaluations or co-monitoring visits with collaborators, as needed.Identifyperformance issues and training opportunities and communicate with leadership, as needed</li></ul></div>
Education and Experience:<div><ul><li>
Bachelor&rsquo;s Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)</li></ul></div><div><ul><li>
5+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)</li></ul></div><div><ul><li>
4+ years of experience with site management &amp; monitoring or managing clinical projects</li></ul></div>
Knowledge and Skills:<div>
Qualifications:</div><div><ul><li>
Strong working knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies</li></ul></div><div><ul><li>
Proficiencywith Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)</li></ul></div><div><ul><li>
Proficient knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)</li></ul></div><div><ul><li>
Strong interpersonal and communication/presentation (oral and written) skills</li></ul></div><div><ul><li>
Strong organizational skills, attention to detail, effective judgment and analytical skills</li></ul></div><div><ul><li>
Able to manage and delegate multiple tasks and prioritize importance of tasks/projects</li></ul></div><div><ul><li>
Ability to travel up to 60% (or more during peak times)</li></ul></div><div>
Preferred Skills &amp; Experience:</div><div><ul><li>
Prior experience with clinical studies related to peripheral vascular diseases, end-stage kidneydiseaseand/or oncology</li></ul></div><div><ul><li>
Experience with medical device studies</li></ul></div><div><ul><li>
Proficiencywith Veeva Vault CTMS, CDMS and eTMF</li></ul></div><div><ul><li>
Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)</li></ul></div>
Physical Demands:
While working in this role, the employeeis regularly required tostand, walk, sit, use sight, and use hands to manipulate,handleor feel objects, tools, controls, and office equipment. The employeefrequentlyis required toverbally communicate with other associates. The employeeis occasionally required toreach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in anopen-cubicleenvironment. The candidatemust be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company&rsquo;s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD&rsquo;s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It&rsquo;s also a place where we help each other be great, we do what&rsquo;s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you&rsquo;ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
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USA AZ - Tempe Headquarters<h1 class="jobSectionHeader">
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Sr. Clinical Research Associate (Remote)

サイネオス・ヘルス

<div><div><div>Updated: Yesterday 
Location: Nida Kule Iş Merkezi G&ouml;ztepe, 34, Turkey 
Job ID: 25107370
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</div></div><div>Description
CRA II - FSP<div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
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 deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
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 building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div>
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>
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.
Summary
Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</div></div></div></div><div></div>

CRA II - FSP

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