clinical trials assistant

Evolution Research Group

<p></p><div><p><b>Job Title: Clinical Trials Assistant (CTA)</b></p><p><b>
Location: Remote</b></p><p><b>
Job Description:</b></p><p>
The Clinical Trials Assistant supports Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. The CTA will archive and organize clinical trial master file documents, including clinical study site documents, generate filing indexes and maintain currents lists of correspondence.</p><p><b>
Essential Duties and Responsibilities:</b></p><ul><li>
Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. Manage clinical, regulatory, and study-related essential documents such as study protocols, Informed Consent Forms, etc.</li><li>
Assist with all aspects of initial study drug release including regulatory packet review and study-drug release.</li><li>
Assist in the preparation and development of study-specific training materials.</li><li>
Participate in the planning of investigator meetings.</li><li>
Interact with sites as needed to respond to issues.</li><li>
Handle incoming and outgoing shipments, as needed.</li><li>
Monitor and track monitoring visit reports. Assist with tracking of clinical trial progress including status update reports, as required.</li><li>
Participate in the review of clinical data at the case report form, data listing, and report table levels.</li><li>
Collect enrollment updates and reports on a weekly basis.</li><li>
Assist with tracking of clinical trial progress, as assigned.</li><li>
Assist PM with set up and preparation of project meetings. May include scheduling the calls, gathering updates from the team, drafting, and finalizing of agenda, sending agenda to the team, and drafting and finalizing minutes.</li><li>
File and QC trial master files.</li><li>
Ensure documents are filed/uploaded into the eTMF in a timely and accurate manner.</li><li>
Review and maintain up-to-date training records for the study team.</li><li>
Document changes in study team members including updating the Study Contact Sheet.</li><li>
Complete Study Plan Checklist for study Plans as assigned.</li><li>
Identify and escalate issues appropriately.</li><li>
May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.</li><li>
Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.</li><li>
Performs other miscellaneous related duties, as required.</li></ul><p><b>
Education and/or Experience:</b></p><ul><li>
BS/BA preferred. High school diploma/certificate or educational equivalent required.</li><li>
Must possess a general knowledge of applicable clinical research requirements, including GCP and ICH guidelines.</li><li>
Minimum of 2 years of clinical research experience required; one year CTA experience preferred but not required.</li><li>
Demonstrated organizational and coordination skills with attention to detail.</li><li>
Solid understanding of clinical drug development is preferred.</li></ul><p><b>
Skills and Abilities:</b></p><ul><li>
Strong Microsoft Office skills.</li><li>
Strong written and verbal communication skills.</li><li>
Effective time management and organizational skills.</li><li>
Attention to detail and accuracy in work.</li><li>
Strong customer service orientation.</li><li>
Ability to work effectively and efficiently handling multiple tasks simultaneously.</li><li>
Ability to facilitate a teamwork philosophy with a positive attitude.</li></ul></div>

CRO-Clinical Trials Assistant (remote)

The University of Iowa

<div><p>The Department of Biostatistics Clinical Trial Statistical Data Management Center is seeking Clinical Trials &amp; Data Management Research Assistant, Associate and Specialist positions, remote and hybrid work available. Responsibilities include assisting in the development of data management plans and identifying appropriate resources for research projects; assisting with designing forms to collect and track study data, subjects, drugs, biological specimens and/or procedures; assisting in the design of database management system applications and developing specifications for data collection and modules; assisting with data processing tasks including data cleaning, reconciliation, and reporting. This position will work closely with external research partners and other CTSDMC team members to determine requirements and create comprehensive solutions for data collection, verification and validation. As a member of the CTSDMC Data Management team, this position will work closely with the IT and Protocol Coordination teams to develop the databases and data entry systems. This position is responsible for mission-critical research applications and sensitive data, so attention to detail and quality are critical.</p><div><b>
Benefits Highlights:</b></div><div></div><div><br>
This is a regular, salaried position. Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans. Complete information regarding the full benefits package may be viewed at: Benefits | University Human Resources - The University of Iowa (uiowa.edu)</div><p><b>
Application Details:</b></p><p>
To be considered for an interview, applicants must upload <b>a resume and cover letter and mark them as a &ldquo;Relevant File&rdquo; to the submission. </b>Job openings are posted for a minimum of <b>14 </b>calendar days and may be removed from posting and filled any time after the original posting period has ended.</p><p>
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to five professional references will be requested at a later step in the recruitment process.</p><p>
This position is eligible for <b>remote or </b><b>hybrid</b> work within Iowa and will require a work arrangement form to be completed upon the start of your employment. Per policy, work arrangements will be reviewed annually, and must comply with the remote work program and related policies and employee travel policy when working at a remote location.</p><p>
Additional Information:</p><p>
Classification Title: Clinical Trials &amp; Data Management Research Assistant, Associate and Specialist</p><p>
Appointment Type: Professional and Scientific</p><p>
Schedule: 100% positions available</p><p>
Work Modality Options: on-campus/Hybrid/remote within Iowa negotiable</p><p>
Pay Level: Research Assistant 3A Research Associate 4A Research Specialist 5A</p><p>
Contact Information:</p><p>
Organization: College of Public Health</p><p>
Contact Name: Kay Shie</p><p>
Contact Email: kay-shie@uiowa.edu</p><br>
<p></p>
<div><p><b>Research Assistant:</b></p><p><b>
Required:</b></p><p>
Requires the academic knowledge of a discipline plus the ability to translate, adapt and apply this knowledge that is generally associated with a Bachelor's degree or an equivalent combination of education and experience</p><p>
Excellent written and verbal communication skills and attention to detail</p><p>
Strong interpersonal and organization skills</p><p>
Ability to apply critical thinking, technical problem solving, and analyzing system specifications</p><p>
Occasional out-of-state travel</p><p>
Knowledge and considerable experience with Microsoft Office Suite or similar software</p><p><b>
Highly Desirable:</b></p><p>
Knowledge and some experience (1 year) with database programming (e.g. SQL), or relational database systems or statistical packages (SAS or R).</p><p><b>
Desirable:</b></p><p>
Knowledge of and/or experience with Azure DevOps for development tracking</p><p>
Knowledge of 21 CFR Part 11 compliance</p><p>
Knowledge of GCP and ICH guidelines</p><p><b>
Research Associate:</b></p><p><b>
Required:</b></p><p>
Requires the academic knowledge of a scientific field including advanced study or demonstrated capacity for scientific research that is generally associated with a Bachelor&rsquo;s degree, supplemented by one or more years of progressively responsible experience in the data management field including data collection tool development and/or data cleaning or an equivalent combination of education and experience</p><p>
Excellent written and verbal communication skills and attention to detail</p><p>
Strong interpersonal and organizational skills</p><p>
Ability to apply critical thinking, technical problem solving, and analyzing system specifications</p><p>
Occasional out-of-state travel</p><p>
Knowledge and considerable experience with Microsoft Office Suite or similar software</p><p><b>
Highly Desirable:</b></p><p>
Knowledge and some experience (2-3 years) with database programming (e.g. SQL), or relational database systems or statistical packages (SAS or R).</p><p><b>
Desirable:</b></p><p>
Knowledge and/or experience with Azure DevOps for development tracking.</p><p>
Familiarity with research processes</p><p>
Experience in design and development of database system and developing specifications for applications</p><p>
Experience with group presentations</p><p>
Knowledge of 21 CFR Part 11 compliance</p><p>
Knowledge of GCP and ICH guidelines</p><p><b>
Research Specialist:</b></p><p><b>
Required:</b></p><p>
Requires the academic knowledge of a scientific field, including advanced study or demonstrated capacity for scientific research, that is generally associated with a Master&rsquo;s degree, supplemented by three or more years of progressively responsible experience in the data management field including data collection tool development and/or data cleaning, or an equivalent combination of education and experience</p><p>
Excellent written and verbal communication skills and attention to detail</p><p>
Strong interpersonal and organizational skills</p><p>
Ability to apply critical thinking, technical problem solving, and analyzing system specifications</p><p>
Occasional out-of-state travel</p><p>
Knowledge and considerable experience with Microsoft Office Suite or similar software</p><p><b>
Highly Desirable:</b></p><p>
Knowledge and experience (4-5 years) with database programming (e.g. SQL), or relational database systems or statistical packages (SAS or R).</p><p>
Experience with Microsoft PowerBI for data visualization</p><p><b>
Desirable:</b></p><p>
Knowledge of and/or experience with Azure DevOps for development tracking</p><p>
Experience conducting clinical or social science research</p><p>
Experience in design and development of database system and developing specifications for applications</p><p>
Experience with group presentations</p><p>
Knowledge of 21 CFR Part 11 compliance</p><p>
Knowledge of GCP and ICH guidelines</p></div></div>

Clinical Trials Research Assistant, Associate and Specialist positions

Oregon Health & Science University

<div>Department Overview:
<div>
The Clinical Trials Unit supports the vision of the Division of Cardiovascular Medicine, the Knight Cardiovascular Institute (KCVI) and OHSU Health to provide Oregonians with state-of-the-art facilities and outstanding staff to advance treatments for cardiovascular diseases. KCVI and OHSU Health proudly collaborate to support clinical research and bring the future of cardiovascular care to the present. Our clinic, located on the South waterfront in CHH1, supports the complex care initiative and the Healthcare mission's priorities, while the CTU provides in patient trial opportunities and procedural care on OHSU main campus as well. Our unit provides the physical infrastructure to perform pharmacological and medical device trials including trials which require infusions, genetic trials, device implants, and cutting-edge imaging.</div><div></div><div><br>
The Knight Cardiovascular Institute Clinical Research Assistant II (Assistant Coordinator) is responsible for various duties related to clinical trials. They will assist the study coordinators in supporting patient visits, assists in data collection and entry for the sponsor, and coordinates patient travel to ensure study subjects are able to meet their visits. This position will primarily support our Cardiomyopathy research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities.</div>
Function/Duties of Position:
<ul><li><div>
Always promotes the mission of the Knight Cardiovascular Institute through our Professional Standards of timely Customer Service, Reliability, Productivity, Professionalism, Accuracy, Timeliness, Integrity, and Problem-Solving.</div></li><li><div>
Responsible for many aspects of clinical trial operations from site initiation visit to closeout and assuring appropriate conduct of protocols to meet FDA guidelines. This includes but is not limited to:</div><ul><li><div>
Works in collaboration with study coordinator to maintain and file regulatory and study documents of active trials to meet study requirements</div></li><li><div>
Create a weekly task list of outstanding items for review to ensure data entry to EDC is captured within obligatory time frames</div></li><li><div>
Collection and transcription of all laboratory and imaging data with guidance from the coordinator as needed.</div></li><li><div>
Data entry of visit data into central data repositories (eCRIS, internal subject trackers, etc.)</div></li><li><div>
Addressing all imaging and laboratory queries in sponsor ERT</div></li><li><div>
Maintaining laboratory reporting and signature requests from the PI</div></li></ul></li><li><div>
Responsible for elements of patient visits including but not limited to:</div></li><li><div>
Work with coordinator in planning visit activities and scheduling participant appointments</div><ul><li><div>
Take point on patient scheduling</div></li><li><div>
Coordination of patient travel</div></li><li><div>
Prepping any necessary documents prior to the visit</div></li><li><div>
Responsible for communicating with patients regarding scheduled appointments</div></li><li><div>
Work with coordinator in collaborating with ancillary departments to make sure all patients receive timely ECHO&rsquo;s, Imaging, vitals (blood pressure, temp, respirations, height, weight) or other study related tasks as needed.
</div></li><li><div>Independently provide follow up for subjects who are no longer receiving treatment in the form of phone calls or clinic visits.</div></li><li><div>
Work with monitoring groups to ensure all data is captured as per protocol</div></li></ul></li><li><div>
Assist the Clinical Trial Leadership, coordinators, or Principal Investigator with other research related projects and administrative/office related duties as needed</div></li><li><div>
Assist manager and coordinator as needed in supporting sponsor visits (i.e. proctoring visits, monitoring, site initiation, etc.)</div></li></ul>
Required Qualifications:
<ul><li><div>
Bachelor's in relevant field <b>OR</b></div></li><li><div>
Associate's <b>AND</b> 2 years of relevant experience <b>OR</b></div></li><li><div>
3 years of relevant experience <b>OR</b></div></li><li><div>
Equivalent combination of training and experience</div></li><li><div>
Ability to prioritize multiple tasks at one time</div></li><li><div>
Must have excellent communication, analytical and organizational skills: both written and verbal.</div></li><li><div>
Ability to work independently and as part of a team while being collaborative in resolving problems.</div></li><li><div>
Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint).</div></li><li><div>
Must have demonstrated excellent customer service skills both on the phone and in person.</div></li><li><div>
Demonstrated ability to work with a variety of diverse individuals and personalities.</div></li><li><div>
Must possess energy and drive to coordinate multiple projects simultaneously.</div></li><li><div>
Ability to use tact and diplomacy to maintain effective working relationships</div></li><li>
Ability to perform the job duties with or without accommodation.</li></ul>
Preferred Qualifications:
<ul><li>Bachelor's degree with coursework in Science</li><li><div>
At least one year general office experience</div></li><li><div>
Knowledge of cardiology. Managing Access database or similar database.</div></li><li><div>
Microsoft office, medical terminology, analytical skills, trouble shooting skills. Ability to work independently as well as within a team environment.</div></li><li><div>
BLS</div></li></ul>
Additional Details:
<div><b>
Location:</b> Marquam Hill &amp; South Waterfront Campus<br>
<b>Schedule:</b> Monday &ndash; Friday, 6am &ndash; 6pm primary business hours with variability depending on clinical schedules with occasional evenings &amp; weekend work to meet project deadlines/goals. As a salaried employee assistant coordinators are expected to flex their time in conjunction with OHSU policy; this may mean working more than 40 hours in a week and then less another.</div><div></div><div><br>
Must be able to travel to all KCVI worksite locations, including potentially using the tram numerous times each day. Will work with human biological samples, including samples which may contain infectious disease. Research assistant Coordinator may be expected to travel to conferences, new study meetings. Clinical Research Assistant Coordinator is required to use Personal Protective Equipment (gloves, masks, etc.) as required to maintain a safe and healthy clinical research environment. Additional safety training may be required to work in clinical research. Position requires ability to focus in a busy cubicle environment with multiple distractions. Position requires successful completion of BLS certification.</div><div></div><div><br>
This is a patient facing on-site roll. Limited remote work is approved on an as needed basis by Clinical Trial Administrator. All obligations to clinical schedules and security of paper PHI and clinical trials regulations must be maintained at all times &ndash; this severely restricting the ability to conduct work remotely.</div>
Why apply to OHSU?:
<div><b>
We are Oregon's only public academic health center.</b> In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington.</div><div><b><br>
All are welcome.</b> OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply. To request reasonable accommodation, contact askhr@ohsu.edu</div></div>

TI Clinical Research Coordinator

Temple University Health System

<div></div><div><div><p>The Temple University&rsquo;s Lewis Katz School of Medicine&rsquo;s Center for Neural Development and Repair is searching for a <b>Clinical Research Assistant</b> to join our team!</p><p><b>
Become a part of the Temple family and you will have access to the following:</b><br>
<i>Full medical, dental, vision coverage</i><br>
<i>Paid time off</i><br>
<i>11 Paid Holidays</i><br>
<i>Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE</i><br>
<i>A generous retirement plan and so much more!</i><br>
<br>
<b>Salary Grade: T23</b><br>
Learn more about the &ldquo;T&rdquo; salary structure</p><p><b>
Salary Range: Up to $45,000.00 per year</b><br>
<i>A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant&rsquo;s education and experience, all relevant internal equity considerations, department budget, and funding source.</i></p><div><b>
Job Details:</b><br>
<ul><li>This position will be on-site</li><li>This position requires the following background checks: Cash Handling</li></ul></div><p><b>
Position Summary:</b><br>
The Clinical Research Assistant works under the direct supervision of the Principal Investigator and/or other Research Coordinators and will assist with specific research tasks associated with clinical research projects or clinical trials. The Clinical Research Assistant is mentored by coordinators, managers and/or the PI. Decisions are made within the limits of clearly established policies, procedures or instructions.</p><p>
At Temple University&rsquo;s Lewis Katz School of Medicine, you will be part of a nationally recognized, state-of-the-art research community that is driving innovation in patient care. Our clinical research programs span a wide range of disciplines and provide coordinators with the opportunity to contribute to groundbreaking studies that directly impact the health and well-being of diverse populations. With access to advanced resources, collaborative teams, and a strong commitment to excellence, Temple offers an ideal environment for Clinical Research Coordinators to grow their careers while shaping the future of medicine.</p><p>
This is a grant-funded position and requires a background check. Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator. Hybrid work options may be considered depending on study and departmental needs.</p><div><b>
Required Education and Experience:</b><br>
<ul><li>Zero to 6 months of related experience is required, or an equivalent combination of education and experience may be considered. The position requires a strong interest in learning about Clinical Research.</li></ul></div><p><b>
Responsibilities:</b><br>
The Clinical Research Assistant performs study coordination tasks under the direct supervision, following established protocols and procedures. This position does not require prior experience in clinical research specifically, however, analytical thinking and attention to detail are necessary with responsibilities that may include performing repetitive tasks such as consenting patients.</p><ul><li>Assist with screening, enrollment and tracking patients in clinical trials and other research studies for the Lewis Katz School of Medicine at Temple University</li><li>May participate in the enrollment of human subjects for clinical trials. Obtain informed consent, schedule subjects for visits, perform basic clinical assessments and collect and enter study data.</li><li>Perform various research, database, and clerical tasks to support clinical trials, aiding investigators in organizing, gathering, and compiling clinical research data.</li><li>Organize and maintain documentation required for clinical trials and/or other research projects.</li><li>Inform the Principal Investigator or other designated individuals about any issues regarding patient responses to treatment, medication, or adverse effects.</li><li>Assist the Principal Investigator with Institutional Review Board (IRB) filings and annual reviews.</li><li>Offer clerical and technical support to ensure adherence to research protocols and maintain the quality of information received.</li><li>Adheres with FDA, IRB, Pennsylvania, and other applicable regulations.</li><li>Performs other duties as assigned</li></ul><div><b>
Required Skills and Abilities:</b><br>
<ul><li>Interest in learning about Clinical Research.</li><li>Demonstrated computer skills, and proficiency with MS Office Suite software programs.</li><li>Aptitude in professionalism.</li><li>Excellent written and oral communication skills.</li></ul></div><div><b>
Additional Information:</b><br>
<ul><li>This is a grant-funded position and requires PII/Cash Handling Clearance prior to the commencement of service</li><li>Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator.</li></ul></div><p><b>
Temple University</b> is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.</p><p><b>
Compliance Statement:</b> In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.<br>
<br>
<b>Temple University's Annual Security and Fire Safety Report </b>contains statistics, policies, and procedures related to campus safety. Go here to review.<br>
<br>
You may request a copy of the report by calling Temple University&rsquo;s <b>Department of Public Safety at 215-204-7900</b>.</p></div></div><p></p>

Clinical Research Assistant

Boston Children's Hospital

<div><div><div><div>84956BR</div>
</div><div><div>Pediatrics-GI/Nutrition
</div></div><div><p><b>Job Posting Description</b></p>
<div><b>Position Summary:</b><br>
We are recruiting a talented and motivated Clinical Research Assistant to join the Inflammatory Bowel Disease (IBD) Center and Fecal Microbiota Transplantation and Therapeutics Program at Boston Children&rsquo;s Hospital. You will work with a research team conducting longitudinal clinical trials and observational studies to provide new insights into the efficacy of novel pharmacologic (parenteral iron) and microbiome-based therapies for inflammatory bowel disease. We leverage our division&rsquo;s expertise in gastroenterology, microbiology, and translational medicine to advance our understanding of these complex diseases and discover new treatments. We are looking for somebody motivated, eager to learn, and able to take the initiative in conducting our clinical trials.<br>
<br>
<b>Key Responsibilities:
</b><ul><li>Coordinating clinical trials and research studies.</li><li>
Recruiting and enrolling study participants in inpatient and outpatient clinical settings.</li><li>
Interacting with study participants and families to gather clinical information, coordinate study visits, and serve as a point of contact for monitoring during the study.</li><li>
Completing data entry for active studies.</li><li>
Conducting medical chart reviews to abstract relevant study data.</li><li>
Assisting with the analysis of clinical metadata compiled from various databases.</li><li>
Assisting with protocol submissions to the Institutional Review Board.</li><li>
Assisting with documentation and communication to the US Food and Drug Administration.</li><li>
Performing laboratory processing of study samples and supporting laboratory experiments relevant to active studies.</li></ul>
<br>
<b>Minimum Qualifications</b><br>
<b>Education:</b><ul><li>
A bachelor's degree is required.</li></ul><br>
<b>
Experience:</b><ul><li>
Willingness to give at least a 2-year commitment to the position.</li><li>
Strong attention to detail and the ability to manage demanding and competing priorities in a fast-paced clinical and research setting.</li><li>
The ability to take initiative, be flexible, and work independently and in a team-based setting.</li><li>
Extremely strong organizational skills.</li><li>
Enjoy working in a collaborative setting with existing team members.</li><li>
Effective communication skills with patients, parents, and study participants to explain the research protocol, obtain informed consent, and record accurate information.</li><li>
Comfortable handling and processing of biological specimens.</li><li>
Computer skills, including, but not limited to, Microsoft Word, Excel, and PowerPoint. Background in statistics, SPSS, or SAS is helpful but not required.</li><li>
The analytical skills to resolve problems that require basic scientific, mathematical, or technical principles.</li></ul></div>
</div><div><p><b>Status</b></p>
<div>Full-Time</div>
</div><div><p><b>Regular, Temporary, Per Diem</b></p>
<div>Regular
</div></div><div><p><b>Standard Hours per Week</b></p>
<div>40
</div></div><div><p><b>Pay Range</b></p>
<div>$41246.40-$61339.20 Annual</div>
</div><div><p><b>Office/Site Location</b></p>
<div>Boston</div>
</div><div><p><b>Job Posting Category</b></p>
<div>Research</div>
</div><div><p><b>Remote Eligibility
</b></p><div>Part Remote/Hybrid</div></div></div></div><div></div>

Planet Pharma

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 <strong>
  The Opportunity:
 </strong>
 Clinical Trial Assistant I
 <br/>
 <br/>
 This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Assistant I (CTA I), you will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of clinical trials. Reporting into the Director (D) you will play a critical role in ensuring trials and studies align with all applicable standards.
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guideline
  </li>
  <li>
   Assist in the development, review, distribution, and archiving of study specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
  </li>
  <li>
   Will lead the set-up and maintenance of the trial master files (TMF), if applicable, and work with the contract research organization (CRO) to audit and resolve discrepancies.
  </li>
  <li>
   Assist project team(s) with sample management and generate trial progress tracking systems.
  </li>
  <li>
   Tracks and prepare study-specific information utilizing databases, trackers, and other study tools.
  </li>
  <li>
   Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal study team meetings.
  </li>
  <li>
   Gather investigator and site information to support study start-up, maintenance, and close-out activities.
  </li>
  <li>
   Assist in contacting investigator sites to provide study specific information.
  </li>
  <li>
   May serve as the point of contact for study sites and study monitors for clinical supplies, document collection, and preparation for close-out visits.
  </li>
  <li>
   Work with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.
  </li>
  <li>
   Liaise with Clinical Supply and other cross functional teams with processing shipments, returns, and assists with in-house drug, specimen, and ancillary supply reconciliation.
  </li>
  <li>
   Support other clinical operations activities as appropriate.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Required Skills, Experience And Education
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in biological sciences or health-related field required.
  </li>
  <li>
   1-3 years relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
  </li>
  <li>
   Has knowledge of GCP ICH Guidelines .
  </li>
  <li>
   Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  </li>
  <li>
   Excellent written/verbal communication and interpersonal skills.
  </li>
  <li>
   Demonstrate proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  </li>
  <li>
   Travel may be required (~10%).
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
  </li>
  <li>
   Oncology experience preferred.
  </li>
  <li>
   Attention to detail.
   <br/>
  </li>
 </ul>
 The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
 <br/>
</div>


Clinical Trial Assistant I - CTA

Concord Retreat

<p><b>Overview</b><br/>We are seeking a dedicated and detail-oriented Clinical Research Assistant to join our dynamic clinical research team. The ideal candidate will play a crucial role in supporting ongoing clinical studies. This position involves working closely with clinical staff to facilitate the successful execution of clinical trials. It is a good opportunity for candidates who are interested to learn about clinical research and/or pursue a career in the medical field.</p><p><b>Responsibilities</b></p><ul><li>Assist in the preparation and execution of clinical research protocols.</li><li>Conduct patient monitoring activities, including recruitment, data collection and help with conducting study visits.</li><li>Support laboratory tasks such as collecting, processing and shipping blood samples.</li><li>Going over database to hep recruiting subjects for clinical studies and answer phone.</li></ul><p><b>Requirements</b></p><ul><li>Bachelor&rsquo;s degree in a relevant field such as biology, life sciences, or a related discipline is preferred.</li><li>Proficiency in Spanish is a must.</li><li>Strong attention to detail with excellent organizational skills.</li><li>Excellent communication skills, both verbal and written, for effective interaction with team members and study participants.</li></ul><p>Join us in advancing clinical research that contributes to significant medical breakthroughs!</p><p>Pay: $18.00 - $20.00 per hour</p><p>Benefits:</p><ul><li>401(k)</li><li>401(k) matching</li><li>Health insurance</li><li>Paid time off</li><li>Retirement plan</li></ul><p>Education:</p><ul><li>Bachelor's (Required)</li></ul><p>Experience:</p><ul><li>medical: 1 year (Preferred)</li></ul><p>Language:</p><ul><li>Spanish (Required)</li></ul><p>Work Location: In person</p>

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