clinical associate

WVU Medicine

<div><h2 class="jobSectionHeader">Welcome! We&rsquo;re excited you&rsquo;re considering an opportunity with us! To apply to this position and be considered, click the Apply button located above this message and complete the application in full. Below, you&rsquo;ll find other important information about this position.
</h2>Performs direct and indirect patient care activities under the supervision of a registered professional nurse. Assists in providing high quality, cost-effective care by performing delegated tasks. Proactively interacts with patients families and other customers to ensure a family centered experience
MINIMUM QUALIFICATIONS :
EDUCATION, CERTIFICATION, AND/OR LICENSURE:
1. High school diploma or equivalent.
2. Obtain certification in Basic Life Support or HeartSaver First Aid within 30 days of hire date.
PREFERRED QUALIFICATIONS :
EXPERIENCE:
1. Prior patient care experience preferred.
CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position. They are not intended to be constructed as an all-inclusive list of all responsibilities and duties. Other duties may be assigned.
1. Assists in direct patient care by providing basic physical care to promote patient comfort as directed by the Registered Nurse.
2. Assists all assigned patients with activities of daily living according to need in a timely manner including making all assigned beds.
3. Safely transports and patients according to WVUH&rsquo;s Safe Patient Handling Policy to all tests and procedures as well as escorts patients for discharge.
4. Transports specimens and items throughout the facility.
5. Performs assigned tests such as glucose monitoring, urine and stool testing and maintains quality control testing &amp; logs, according to department policy. On Subacute Unit, CNAs are not permitted to do glucose monitoring.
6. Performs routine phlebotomy services, excluding line draws, in departments determined by management.
7. Obtains and records assigned patient temperatures, pulse rates, respiratory rates, blood pressures, intake and outputs, weights and abdominal girths according to departmental policy.
8. Provides respiratory support by properly setting up equipment needed for oxygen administration.
9. Encourage the usage of Incentive Spirometer according to Respiratory Care procedure.
10. Observes and reports all patient concerns/changes in condition to a registered nurse immediately.
11. Prepares patients for examinations and diagnostic procedures according to departmental procedure.
12. Assists physicians and registered nurse with examinations and procedures.
13. Assists with basic rehab/Physical Therapy activities, i.e. active and passive range of motion and ambulation.
14. Communicates with RN regarding any nutrition issues, such as poor appetite or verbalized lack of understanding of diet changes
15. Provides total care within scope of practice (vital signs, activities of daily living) when assigned sitter or constant visual responsibilities.
16. Assists in indirect patient care by maintaining a clean and safe environment to help prevent and/or control infections and to provide for safety of patients, visitors and employees.
17. Maintains clean assigned, unit equipment according to departmental procedures.
18. Reports all necessary equipment repairs to appropriate personnel according to departmental procedure in a timely manner.
19. Assists in routine unit operations as directed/needed to assure smooth communication and functioning of the unit.
20. Courteously answers telephone in a timely manner, identifying self and unit at all times.
21. Courteously answers patient call bell and relays message to the appropriate personnel.
22. Relays accurate telephone, visitor and patient messages to appropriate persons in a timely manner.
23. Promptly completes errands as requested.
24. Unlicensed assistive personnel (UAP) may have limited access to medications including during transport of non-controlled substances at the request of a licensed care provider.
25. Removes out of date items.
PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
1. Heavy/Hard work: Work requires strength and/or stamina, lifting, moving, stooping, reaching, standing, and walking. Handling of materials and equipment weighing up to 50 pounds. Pushing/Pulling carts weighing up to 200 pounds.
2. The National Institute for Occupational Safety and Health recommends minimizing the need for employees to manually lift patients, and limit safe patient handling to 35 pounds. All transfers, lifts and re-positioning will be completed utilizing the lift equipment and/or other patient handling aids as indicated by the patient&rsquo;s profile and appropriate algorithms.
3. Must be able to sit, walk or stand for prolonged periods of time. 
WORKING ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
SKILLS AND ABILITIES:
1. Demonstrate competency in the use of Safe Patient Handling equipment.
2. Excellent communication skills and strong customer service orientation.
3. Experience in dealing with simultaneously, multiple demands.
4. Good time management skills.
Additional Job Description:
7pm-730am
Scheduled Weekly Hours:
24
Shift:
Night (United States of America)
Exempt/Non-Exempt:
United States of America (Non-Exempt)
Company:
WVUH West Virginia University Hospitals
Cost Center:
21 WVUH Nursing 7 East
Address:
1 Medical Center Drive
Morgantown
West Virginia
Equal Opportunity Employer 
West Virginia University Health System and its subsidiaries (collectively &quot;WVUHS&quot;) is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. WVUHS strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law. All WVUHS employees, other workers, and representatives are prohibited from engaging in unlawful discrimination. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and termination of employment.</div>

Clinical Associate-7 East

<div><h2 class="jobSectionHeader">Welcome! We&rsquo;re excited you&rsquo;re considering an opportunity with us! To apply to this position and be considered, click the Apply button located above this message and complete the application in full. Below, you&rsquo;ll find other important information about this position.
</h2>Performs direct and indirect patient care activities under the supervision of a registered professional nurse. Assists in providing high quality, cost-effective care by performing delegated tasks. Proactively interacts with patients families and other customers to ensure a family centered experience
MINIMUM QUALIFICATIONS :
EDUCATION, CERTIFICATION, AND/OR LICENSURE:
1. High school diploma or equivalent.
2. Obtain certification in Basic Life Support or HeartSaver First Aid within 30 days of hire date.
PREFERRED QUALIFICATIONS :
EXPERIENCE:
1. Prior patient care experience preferred.
CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position. They are not intended to be constructed as an all-inclusive list of all responsibilities and duties. Other duties may be assigned.
1. Assists in direct patient care by providing basic physical care to promote patient comfort as directed by the Registered Nurse.
2. Assists all assigned patients with activities of daily living according to need in a timely manner including making all assigned beds.
3. Safely transports and patients according to WVUH&rsquo;s Safe Patient Handling Policy to all tests and procedures as well as escorts patients for discharge.
4. Transports specimens and items throughout the facility.
5. Performs assigned tests such as glucose monitoring, urine and stool testing and maintains quality control testing &amp; logs, according to department policy. On Subacute Unit, CNAs are not permitted to do glucose monitoring.
6. Performs routine phlebotomy services, excluding line draws, in departments determined by management.
7. Obtains and records assigned patient temperatures, pulse rates, respiratory rates, blood pressures, intake and outputs, weights and abdominal girths according to departmental policy.
8. Provides respiratory support by properly setting up equipment needed for oxygen administration.
9. Encourage the usage of Incentive Spirometer according to Respiratory Care procedure.
10. Observes and reports all patient concerns/changes in condition to a registered nurse immediately.
11. Prepares patients for examinations and diagnostic procedures according to departmental procedure.
12. Assists physicians and registered nurse with examinations and procedures.
13. Assists with basic rehab/Physical Therapy activities, i.e. active and passive range of motion and ambulation.
14. Communicates with RN regarding any nutrition issues, such as poor appetite or verbalized lack of understanding of diet changes
15. Provides total care within scope of practice (vital signs, activities of daily living) when assigned sitter or constant visual responsibilities.
16. Assists in indirect patient care by maintaining a clean and safe environment to help prevent and/or control infections and to provide for safety of patients, visitors and employees.
17. Maintains clean assigned, unit equipment according to departmental procedures.
18. Reports all necessary equipment repairs to appropriate personnel according to departmental procedure in a timely manner.
19. Assists in routine unit operations as directed/needed to assure smooth communication and functioning of the unit.
20. Courteously answers telephone in a timely manner, identifying self and unit at all times.
21. Courteously answers patient call bell and relays message to the appropriate personnel.
22. Relays accurate telephone, visitor and patient messages to appropriate persons in a timely manner.
23. Promptly completes errands as requested.
24. Unlicensed assistive personnel (UAP) may have limited access to medications including during transport of non-controlled substances at the request of a licensed care provider.
25. Removes out of date items.
PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
1. Heavy/Hard work: Work requires strength and/or stamina, lifting, moving, stooping, reaching, standing, and walking. Handling of materials and equipment weighing up to 50 pounds. Pushing/Pulling carts weighing up to 200 pounds.
2. The National Institute for Occupational Safety and Health recommends minimizing the need for employees to manually lift patients, and limit safe patient handling to 35 pounds. All transfers, lifts and re-positioning will be completed utilizing the lift equipment and/or other patient handling aids as indicated by the patient&rsquo;s profile and appropriate algorithms.
3. Must be able to sit, walk or stand for prolonged periods of time. 
WORKING ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
SKILLS AND ABILITIES:
1. Demonstrate competency in the use of Safe Patient Handling equipment.
2. Excellent communication skills and strong customer service orientation.
3. Experience in dealing with simultaneously, multiple demands.
4. Good time management skills.
Additional Job Description:
Scheduled Weekly Hours:
36
Shift:
Night (United States of America)
Exempt/Non-Exempt:
United States of America (Non-Exempt)
Company:
WVUH West Virginia University Hospitals
Cost Center:
35 WVUH CH Nursing Pediatrics Neonatal ICU
Address:
1 Medical Center Drive
Morgantown
West Virginia
Equal Opportunity Employer 
West Virginia University Health System and its subsidiaries (collectively &quot;WVUHS&quot;) is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. WVUHS strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law. All WVUHS employees, other workers, and representatives are prohibited from engaging in unlawful discrimination. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and termination of employment.</div>

Clinical Associate - Children's NICU

ICON Strategic Solutions

<div>
 
 At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON&rsquo;s global expertise. As the world&rsquo;s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
 
 
 
 
 
 ** Must have 2 years of onsite monitoring experience**
 
 
 **Must have Ophthalmology experience**
 
 
 
 
 
 We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
 
 
 
 
 
 
 What you will be doing
 
 
 <ul>
 <li>
 Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
 </li>
 <li>
 Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
 </li>
 <li>
 Collaborating with investigators and site staff to facilitate smooth study conduct.
 </li>
 <li>
 Performing data review and resolution of queries to maintain high-quality clinical data.
 </li>
 <li>
 Contributing to the preparation and review of study documentation, including protocols and clinical study reports
 </li>
 </ul>
 
 
 
 
 
 Your profile
 
 
 <ul>
 <li>
 Bachelor's degree in a scientific or healthcare-related field.
 </li>
 <li>
 Minimum of 2 years of experience as a Clinical Research Associate.
 </li>
 <li>
 In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
 </li>
 <li>
 Strong organizational and communication skills, with attention to detail.
 </li>
 <li>
 Ability to work independently and collaboratively in a fast-paced environment.
 </li>
 <li>
 Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license
 </li>
 </ul>
 
 
 
 
 Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
 
 
 
 Rewards &amp; Benefits
 
 
 
 ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
 
 
 Benefits may include:
 
 <ul>
 <li>
 Competitive base salary and performance related incentives
 </li>
 <li>
 Health and wellbeing programmes including medical, dental, and vision coverage where applicable
 </li>
 <li>
 Retirement and pension plans
 </li>
 <li>
 Life assurance and disability coverage
 </li>
 <li>
 Employee assistance programmes and wellbeing resources
 </li>
 <li>
 Learning and development opportunities through structured training and career pathways
 </li>
 </ul>
 
 Benefits may vary depending on role and location.
 
 
 
 
 
 
 Inclusion and Accessibility
 
 
 
 ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
 
 
 If you require reasonable accommodations during the recruitment process, please let us know or submit a request
 
 here
 
 .
 
 
 Are you a current ICON Employee? Please click
 
 here
 
 to apply.
 
 
 
</div>

Clinical Research Associate

ICON plc

<div>Clinical Research Associate - California
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
As a CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.
What You Will Do:
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. 
 
Key responsibilities include:<ul><li>
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.</li><li>
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.</li><li>
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.</li><li>
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.</li><li>
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.</li></ul>
Your Profile:
You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</li><li>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</li><li>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</li><li>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul>
What ICON can offer you:<div><div><div><div>
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
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.<div><div><div><div>
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<div>
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.</div></div></div></div></div></div>

RTI LABORATORIES

Job Summary We are seeking a dynamic and detail-oriented Clinical Research Associate (CRA) to join our innovative clinical development team. In this vital role, you will oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory standards and study protocols. Your expertise will drive the successful management of clinical research projects, ensuring data integrity, patient safety, and adherence to all applicable regulations. This position offers an exciting opportunity to contribute to groundbreaking medical advancements while working in a collaborative and fast-paced environment.Responsibilities<ul><li>Coordinate and monitor clinical trials across multiple sites, ensuring adherence to study protocols, FDA regulations, ICH GCP guidelines, and company standards. </li><li>Conduct site qualification visits, initiate visits, routine monitoring visits, and close-out visits to verify compliance and data accuracy. </li><li>Review and verify source documents, case report forms (CRFs), and other trial documentation for completeness and accuracy. </li><li>Provide training and support to site staff on protocol procedures, data collection methods, EMR systems, and regulatory requirements. </li><li>Monitor patient safety by reviewing adverse event reports, ensuring proper documentation, and reporting to relevant authorities as required. </li><li>Manage trial documentation including ethics submissions, informed consent forms, regulatory binders, and audit readiness files. </li><li>Collaborate with cross-functional teams such as clinical operations, data management, laboratory personnel, and medical staff to facilitate smooth trial execution. </li><li>Ensure compliance with HIPAA regulations concerning patient confidentiality and data security. </li><li>Assist in the review of clinical laboratory results, vital signs data, blood sampling procedures (phlebotomy), and other clinical assessments. </li><li>Support statistical analysis activities by coordinating with statisticians using software tools designed for clinical data analysis. </li><li>Maintain detailed records of site communications, monitoring reports, and trial progress for audit purposes.</li></ul>Experience<ul><li>Proven supervising experience in managing clinical trials or overseeing clinical research teams. </li><li>Extensive knowledge of clinical trials management processes from initiation through close-out phases. </li><li>Strong understanding of medical terminology, FDA regulations, ICH GCP guidelines, and CDISC standards for data exchange. </li><li>Hands-on experience with EMR systems and electronic data capture (EDC) platforms for efficient data management. </li><li>Background in nursing or clinical laboratory work (including blood sampling and vital signs measurement) is highly desirable. </li><li>Familiarity with statistical software used in clinical research for data analysis purposes. </li><li>Certification such as ICH GCP certificate from a recognized issuer (including CA) is required; additional certifications in HIPAA compliance or phlebotomy are a plus. </li><li>Excellent analysis skills combined with meticulous attention to detail to ensure high-quality documentation review and compliance management. Join us in advancing medical science through rigorous research practices! We value energetic professionals committed to excellence in clinical development who thrive in collaborative environments dedicated to improving patient outcomes worldwide.</li></ul>Pay: $51,498.23 - $62,019.38 per yearWork Location: In person

Alliance for Clinical Trials in Oncology

<div>
 
 The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
 
 
 In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners.
 
 
 The Alliance Foundation Trials (AFT) is seeking a Clinical Research Associate (CRA) to support the management and execution of clinical trial operations across AFT studies. This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS. The CRA will collaborate closely with CROs, vendors, and investigative sites to ensure studies are conducted in compliance with ICH GCP guidelines and organizational standards, while supporting studies from start-up through ongoing maintenance. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer.
 
 
 Benefits of working at the Alliance for Clinical Trials in Oncology Foundation:
 
 <ul>
 <li>
 8 weeks of paid time off (including PTO, sick, and holidays) during year one
 </li>
 <li>
 Medical, Dental &amp; Vision plans with a 100% employer-paid option for employees
 </li>
 <li>
 Tuition reimbursement stipends
 </li>
 <li>
 Continuing Education
 </li>
 <li>
 3% employer match for retirement investments
 </li>
 <li>
 Annual Employee Performance Bonus Program
 </li>
 <li>
 Annual Cost of Living Adjustment
 </li>
 <li>
 50% commuter reimbursement
 </li>
 <li>
 Healthy Work/Life balance and flexibility
 
 </li>
 </ul>
 
 
 ROLE AND RESPONSIBILITIES
 
 
 
 &bull; Assist operations team in supporting the Alliance member sites and escalate site related issues when necessary.
 
 
 &bull; Send, track, and review study-specific and global feasibility questionnaires.
 
 
 &bull; Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and follow-up on site accruals accordingly.
 
 
 &bull; Track training information and issue trainings for sites and contacts.
 
 
 &bull; Collection of essential documents related to study start-up and review IP release packages.
 
 
 &bull; Prepare for and execute Investigator meetings and other site training programs.
 
 
 &bull; Assist with creation of start-up plans and templates.
 
 
 &bull; Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations.
 
 
 &bull; Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.
 
 
 &bull; Accurately enter and manage data within the Clinical Trial Management System (CTMS) by: tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts.
 
 
 &bull; Participate in co-monitoring activities.
 
 
 &bull; Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.
 
 
 &bull; Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team
 
 
 &bull; Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.
 
 
 &bull; Other related duties as assigned to meet departmental and company objectives.
 
 
 
 
 Requirements
 
 
 
 
 
 QUALIFICATIONS AND EDUCATION REQUIREMENTS
 
 
 
 &bull; A minimum of a BA/BS degree is required.
 
 
 &bull; Degree in a health or science major preferred.
 
 
 &bull; 2 - 4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.
 
 
 &bull; Working knowledge of clinical monitoring responsibilities and procedures.
 
 
 &bull; Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
 
 
 &bull; Proficient in Microsoft Office Suite, especially Word and Excel.
 
 
 
 PREFERRED SKILLS
 
 
 
 &bull; Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.
 
 
 &bull; Strong interpersonal, written, and verbal communication skills.
 
 
 &bull; Flexible and adaptable to a small business workplace environment.
 
</div>

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>

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