clinical monitor

Novum Pharmaceutical Research Services

<p>Would you like to work for a global company with small company values like teamwork and a commitment to excellence? At Novum, our mission is to ensure excellence where everyone works as an integral part of the team to get the job done? We have a commitment to an ongoing learning process and professional development. As part of the Novum Pharmaceutical Research Services team you will work with inspiring managers and talented coworkers who are all empowered to make significant and lasting contributions to the world we live in.<br/>The Clinical Research Associate is Responsible for independent monitoring of multi-site assignments for Clinical Studies. Ensure adherence to Good Clinical Practices, investigator integrity and compliance with protocol and study procedures, at Investigator sites, in accordance with Novum SOP&rsquo;s.<br/>Essential Responsibilities:</p><ul><li>Review Regulatory Documents from Investigator Sites for completeness and accuracy.</li><li>Bilingual in Spanish and English</li><li>Conduct site selection, initiation, close out and interim monitoring visits at assigned Investigator sites.</li><li>Review study site data to ensure compliance with the study protocol.</li><li>Verify CRF&rsquo;s with source documentation.</li><li>Track SAE&rsquo;s reporting at Investigator Sites.</li><li>Meet with Sponsor representatives as requested.</li><li>Review site&rsquo;s regulatory binder to ensure that the master study files contain the most up to date information.</li><li>Review site&rsquo;s drug accountability logs per patients and overall.</li><li>Monitor informed consents signed by study patients to ensure that the patients were consented properly and with the current revision.</li><li>Work with sites to resolve queries in a timely manner.</li><li>Other duties as assigned.</li></ul><p>Qualifications:</p><ul><li>Bachelor's degree; and two years experience specifically as a Clinical Research Associate with a CRO or equivalent combination of education and experience.</li><li>80% travel required which may be irregular and may include international travel.</li><li>Working knowledge of MS Office software.</li></ul><p>Licensing/Certification Requirements:</p><ul><li>Valid Driver&rsquo;s License is required.</li></ul><p>Novum provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.<br/>This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.</p><p>Job Type: Full-time</p><p>Benefits:</p><ul><li>401(k)</li><li>Dental insurance</li><li>Flexible schedule</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Referral program</li><li>Vision insurance</li></ul><p>Application Question(s):</p><ul><li>Will you now or in the future require sponsorship for employment visa status? (For example, are you now working for another employer in H-1B status who will need an H-1B transfer, or are you an F-1 student who will need H-1B sponsorship in the future?)</li><li>Have you ever been employed with our organization?</li><li>Are you able to perform the tasks listed under the &quot;Job Requirements&quot; section of the job description, either with or without accommodations?</li><li>What are you salary expectations?</li><li>Are you eligible to work legally in the United States? </li></ul><p>Willingness to travel:</p><ul><li>75% (Required)</li></ul><p>Work Location: Remote</p>

Clinical Research Associate

Ray-CRO

<p>Clinical Research Associate (CRA) Opportunity &ndash; Saudi Arabia</p><p>RAY-CRO is expanding its operations in Saudi Arabia and is seeking a qualified Clinical Research Associate (CRA) to support regional clinical research activities and contribute to high-quality study execution.</p><p>The successful candidate will be responsible for:</p><ul><li>End-to-end site management from initiation through close-out</li><li>Ensuring compliance with ICH-GCP, study protocols, and applicable regulatory requirements</li><li>Effective communication with investigative sites, sponsors, and internal teams</li><li>Proactive issue identification and resolution</li><li>Maintaining high standards of quality, timelines, and patient safety</li></ul><p>Location: KSA<br/>Applications: careers@ray-cro.com</p><p>This is an excellent opportunity to join a regional CRO with an expanding clinical research footprint in Saudi Arabia.</p><p>Job Type: Full-time</p><p>Work Location: In person</p>

BeOne Medicines

<div><div>BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.</div><div></div><div>
General Description:</div><div></div><ul><li>
The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.</li><li>
Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.</li><li>
The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.</li><li>
Identify gaps and areas for improvement and propose CAPA.</li><li>
Supports start-up and provides local expertise.</li><li>
SSU experience is considered a plus</li></ul><div></div><div>
CRA activities</div><ul><li><div>
Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets</div></li><li><div>
Provides protocol and related study training to assigned sites.</div></li><li><div>
Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs</div></li><li><div>
Conducts co-monitoring visits, if required</div></li><li><div>
Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP</div></li><li><div>
Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.</div></li><li><div>
Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations</div></li><li><div>
Ensure inspection readiness of the study and sites</div></li><li><div>
Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)</div></li><li><div>
Attends disease indication project specific training and general CRA training as required</div></li><li><div>
Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required</div></li><li><div>
Evaluates the quality and integrity of site practices &ndash; escalating quality and/or GCP issues with Investigators and internal team as appropriate.</div></li><li><div>
Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.</div></li></ul><div></div><div>
Education Required:</div><ul><li><div>
BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.</div></li><li><div>
Experience in oncology global trials preferred</div></li></ul><div></div><div>
Other Qualifications:</div><ul><li><div>
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines</div></li><li><div>
At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry</div></li><li><div>
Experience in oncology/hematology trials preferred</div></li><li><div>
Excellent communication and interpersonal skills</div></li><li><div>
Excellent organizational skills and ability to prioritize and multi-task</div></li><li><div>
Fluent in English &amp; Turkish (writing and speaking)</div></li></ul><div></div><div>
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook</div><div></div><div>
Travel: up to 60%</div><div></div><div>
Global Competencies</div><div>
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.</div><ul><li>
Fosters Teamwork</li><li>
Provides and Solicits Honest and Actionable Feedback</li><li>
Self-Awareness</li><li>
Acts Inclusively</li><li>
Demonstrates Initiative</li><li>
Entrepreneurial Mindset</li><li>
Continuous Learning</li><li>
Embraces Change</li><li>
Results-Oriented</li><li>
Analytical Thinking/Data Analysis</li><li>
Financial Excellence</li><li>
Communicates with Clarity</li></ul><div></div><div>
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.</div></div><div></div>

Parexel

<div>
 <strong>
  Key Accountabilities
  <br/>
  <br/>
 </strong>
 <strong>
  Site Management Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Contributes to the selection of potential investigators.
  </li>
  <li>
   In some countries, as required, Sr CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
  </li>
  <li>
   Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
  </li>
  <li>
   Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.
  </li>
  <li>
   Actively participates in Local Study Team (LST) meetings.
  </li>
  <li>
   Contributes to National Investigators meetings, as applicable.
  </li>
  <li>
   Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
  </li>
  <li>
   Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
  </li>
  <li>
   Updates CTMS and other systems with data from study sites as per required timelines.
  </li>
  <li>
   Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
  </li>
  <li>
   Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
  </li>
  <li>
   Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
  </li>
  <li>
   Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
  </li>
  <li>
   Ensures data query resolution in a timely manner.
  </li>
  <li>
   Works with data management to ensure robust quality of the collected study data.
  </li>
  <li>
   Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
  </li>
  <li>
   Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
  </li>
  <li>
   Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
  </li>
  <li>
   Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
  </li>
  <li>
   Assists site in maintaining inspection ready ISF.
  </li>
  <li>
   Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
  </li>
  <li>
   Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
  </li>
  <li>
   Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
  </li>
  <li>
   Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
  </li>
  <li>
   Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Compliance with Sponsor Standards
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Ensures compliance with the Client&rsquo;s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
  </li>
  <li>
   Ensures compliance with local, national, and regional legislation, as applicable.
  </li>
  <li>
   Completes timesheets accurately as required
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Compliance with Parexel Standards
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Complies with required training curriculum.
  </li>
  <li>
   Completes timesheets accurately as required.
  </li>
  <li>
   Submits expense reports as required.
  </li>
  <li>
   Updates CV as required.
  </li>
  <li>
   Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Skills (Essential)
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Excellent attention to detail.
  </li>
  <li>
   Good written and verbal communication skills.
  </li>
  <li>
   Good collaboration and interpersonal skills.
  </li>
  <li>
   Good negotiation skills.
  </li>
  <li>
   Proficient in written and spoken English language required.
  </li>
  <li>
   Fluency in local language(s) required.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Skills (Desirable)
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
  </li>
  <li>
   Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
  </li>
  <li>
   Good analytical and problem-solving skills.
  </li>
  <li>
   Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
  </li>
  <li>
   Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
  </li>
  <li>
   Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):
  </li>
  <li>
   Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
  </li>
  <li>
   Good knowledge of relevant local regulations.
  </li>
  <li>
   Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
  </li>
  <li>
   Basic understanding of the drug development process.
  </li>
  <li>
   Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Knowledge And Experience (Desirable)
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Familiar with risk-based monitoring approach including remote monitoring.
  </li>
  <li>
   Good cultural awareness.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Education
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Other
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Ability to travel nationally/internationally as required.
  </li>
  <li>
   Valid driving license per country requirements, as applicable
  </li>
 </ul>
</div>


Senior Clinical Research Associate & CRAII  - FSP (Open)

Syneos Health

<div><p><b>Description</b>
</p>Sr CRA II - FSP - Turkey - Homebased<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p><p></p><p>
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><p></p><p><b>
Job Responsibilities</b></p><p></p><ul><li>
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (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 via review of site source documents and medical records<br>
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines<br>
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 action items to resolution.</li><li>
Understands project scope, budgets, and timelines for own and others&rsquo; activities in the clinical team; 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 and may lead 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>
May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.</li><li>
For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.Site Management Associate II. Additional responsibilities include:<br>
Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs<br>
Chart abstraction activities and data collection<br>
As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff<br>
The SMA II may be requested to train junior staff<br>
Identify and communicate out of scope activities to Lead CRA/Project Manager<br>
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.<br>
Identify operational efficiencies and process improvements<br>
Develop study and country level informed consent forms<br>
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared<br>
Participate in bid defense meetings<br>
Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy.<br>
Participate in Case Report Form design and edit check development.</li></ul><p></p><p>
Qualifications:</p><p></p><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. Moderate level of critical thinking skills expected.</li><li>
Ability to manage required travel of up to 75% on a regular basis</li></ul><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
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.</p><p></p><p>
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.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
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.</p><p><b>
Summary</b>
</p>Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring.Impact and ContributionIndividual 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. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div>

Sr CRA II - FSP - Turkey - Homebased

CTI Clinical Trial and Consulting

<div><div><b>Senior Clinical Research Associate (</b><b>home based</b><b>) (Level dependent on experience)</b></div>
<div><br>
To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance.<br>
<br>
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.<br>
<br>
<b>What You'll Do</b></div>
<ul><li>Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor.</li>
<li>Creates and implements subject enrollment strategies for assigned investigative sites.</li>
<li>Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan.</li>
<li>Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.</li>
<li>Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product.</li>
<li>Participates in development of CRFs and other study related documents</li>
</ul><div><b>What You Bring</b></div>
<ul><li>Bachelor&rsquo;s or Master&rsquo;s Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or</li>
<li>RN with Associate&rsquo;s Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience</li>
</ul><div><b>Why CTI?</b>
<div>At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.</div>
<div>For that reason, we treat our team members with the respect they deserve, and our numbers show it:</div>
<ul><li>We support career progression &ndash; We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward</li>
<li>We value education and training &ndash; We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department</li>
<li>We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.</li>
<li>Our culture is unparalleled &ndash; We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry</li>
<li>We think globally and act locally &ndash; With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.</li>
<li>We are looking toward the future &ndash; We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs</li>
<li>Our work makes a difference &ndash; We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market</li></ul></div></div>

Senior Clinical Research Associate (level dependent on experience)

<div><div><b>Senior Clinical Research Associate (</b><b>home based</b><b>) (level dependent on experience)</b><br>
<b>Job Purpose/Summary</b></div>
<div><br>
To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance.<br>
<br>
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.<br>
<br>
<b>What You'll Do</b></div>
<ul><li>Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor.</li>
<li>Creates and implements subject enrollment strategies for assigned investigative sites.</li>
<li>Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan.</li>
<li>Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.</li>
<li>Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product.</li>
<li>Participates in development of CRFs and other study related documents</li>
</ul><div><b>What You Bring</b></div>
<ul><li>Bachelor&rsquo;s or Master&rsquo;s Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or</li>
<li>RN with Associate&rsquo;s Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience</li>
</ul><div><b>Why CTI?</b>
<div>At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.</div>
<div>For that reason, we treat our team members with the respect they deserve, and our numbers show it:</div>
<ul><li>We support career progression &ndash; We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward</li>
<li>We value education and training &ndash; We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department</li>
<li>We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.</li>
<li>Our culture is unparalleled &ndash; We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry</li>
<li>We think globally and act locally &ndash; With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.</li>
<li>We are looking toward the future &ndash; We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs</li>
<li>Our work makes a difference &ndash; We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market</li></ul></div></div>

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