clinical trial associate

ImmunityBio, Inc.

<div>
 
 Company Overview
 
 
 
 ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient&rsquo;s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient&rsquo;s immune system and treat the host rather than just the disease.
 
 
 Why ImmunityBio?
 
 
 <ul>
 <li>
 ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
 </li>
 <li>
 Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
 </li>
 <li>
 Work with a collaborative team with the ability to work across different areas of the company.
 </li>
 <li>
 Ability to join a growing company with professional development opportunities.
 
 
 </li>
 </ul>
 
 Position Summary
 
 
 
 The Clinical Research Associate I will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.
 
 
 
 Essential Functions
 
 
 
 <ul>
 <li>
 Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
 </li>
 <li>
 Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
 </li>
 <li>
 Communicate scientific rationale for assigned studies to team members and clinical sites
 </li>
 <li>
 Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
 </li>
 <li>
 Create/edit, distribute and collect site feasibility questionnaires
 </li>
 <li>
 Oversee and support collection of essential documents during study start-up
 </li>
 <li>
 Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.
 </li>
 <li>
 Collect study and site metrics and maintain study trackers, as needed
 </li>
 <li>
 Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
 </li>
 <li>
 Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits
 </li>
 <li>
 Partner with field CRAs and CTAs to resolve issues identified during site visits
 </li>
 <li>
 Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions
 </li>
 <li>
 Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
 </li>
 <li>
 Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor
 </li>
 <li>
 Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors
 </li>
 <li>
 Conduct remote monitoring tasks including reconciliation of site investigational product accountability
 </li>
 <li>
 Provide data listings and compile clinical study report documents to support medical writing activities
 </li>
 <li>
 Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
 </li>
 <li>
 Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate.
 </li>
 <li>
 Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
 
 
 </li>
 </ul>
 
 Education &amp; Experience
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in a clinical research, science, or health-related field with 2 years of experience in a clinical research setting; or a high school diploma with 3 years of experience in a clinical research setting required
 </li>
 <li>
 2 years of experience as a Clinical Research Coordinator, Clinical Trial Associate or In-House Clinical Research Associate strongly preferred
 
 
 </li>
 </ul>
 
 Knowledge, Skills, &amp; Abilities
 
 
 
 <ul>
 <li>
 Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
 </li>
 <li>
 Excellent written/oral communication skills
 </li>
 <li>
 Strong organizational and multi-tasking skills
 </li>
 <li>
 Maintain corporate confidentiality at all times
 </li>
 <li>
 Ability to set priorities and independent decision making
 </li>
 <li>
 Ability to work independently as well as in teams
 </li>
 <li>
 Strong oral and written communication skills
 </li>
 <li>
 Outgoing and confident demeanor
 </li>
 <li>
 Independent thinker and persuasive communicator
 </li>
 <li>
 Detail oriented, with solid organization and time management skills
 </li>
 <li>
 Completes projects with reliability and minimal guidance
 </li>
 <li>
 Knowledge of drug development process
 </li>
 <li>
 Computer literacy: EDC, eTMF, CTMS, etc.
 </li>
 <li>
 Working knowledge of ICH E6, and the Code of Federal Regulations
 
 
 </li>
 </ul>
 
 Working Environment / Physical Environment
 
 
 
 <ul>
 <li>
 This position works remotely with ability to work flexible hours for various time zones
 </li>
 <li>
 Must be able to travel up to 75% of the time based on study requirement.
 
 
 </li>
 </ul>
 This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate&rsquo;s qualifications, prior experience as well as geographic location.
 
 
 $103,900 (entry-level qualifications) to $114,300 (highly experienced) annually
 
 
 The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
 
 
 ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options
 
 
 <ul>
 <li>
 Health and Financial Wellness Programs
 </li>
 <li>
 Employer Assistance Program (EAP)
 </li>
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 Company Paid and Voluntary Life/AD&amp;D, Short-Term and Long-Term Disability
 </li>
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 Healthcare and Dependent Care Flexible Spending Accounts
 </li>
 <li>
 401(k) Retirement Plan with Company Match
 </li>
 <li>
 529 Education Savings Program
 </li>
 <li>
 Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
 </li>
 <li>
 Paid Time Off (PTO) includes: 11 Holidays
 </li>
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 Exempt Employees are eligible for Unlimited PTO
 </li>
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 Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
 </li>
 <li>
 We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
 
 
 </li>
 </ul>
 At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
</div>

Clinical Research Associate I, Field Monitor

Alira Health

<div>Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don&rsquo;t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
Job Description<h2 class="jobSectionHeader">
ROLE</h2>
The In-house CRA is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel.<h2 class="jobSectionHeader">
KEY RESPONSABILITIES</h2><ul><li>
Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc.</li><li>
Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs</li><li>
Responds to sites&rsquo; regulatory board requests for protocol and ICF clarification as needed</li><li>
Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment</li><li>
Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews</li><li>
Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites</li><li>
Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests</li><li>
Conducts remote review of data entered on electronic Case Report Forms (eCRFs)</li><li>
Works closely with field CRAs and data management to resolve queries on discrepant data</li><li>
Assists with efforts to recruit investigative sites to participate in clinical studies</li><li>
Complies with ICH GCP guidelines, FDA regulations, and company SOPs</li><li>
Participates in internal, client/sponsor, scientific, and other meetings as required</li><li>
Manages and resolves conflicting priorities to deliver on commitments</li><li>
Performs additional duties as assigned</li></ul><h2 class="jobSectionHeader">
DESIRED QUALIFICATION &amp; EXPERIENCE</h2><ul><li>
BS/BA from an undergraduate program or equivalent experience</li><li>
1-2 years of experience in clinical research</li></ul><h2 class="jobSectionHeader">
TECHNICAL COMPETENCES &amp; SOFT SKILLS</h2><ul><li>
Proven ability to be careful, thorough, and detail-oriented</li><li>
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment</li><li>
Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills</li><li>
Self-starter who thrives in a collaborative, yet less structured team environment</li><li>
Ability to problem-solve unstructured or ambiguous challenges</li><li>
Strong command of English, both written and verbal</li><li>
Excellent communication and interpersonal skills with customer service orientation</li><li>
Proficient with MS Office Suite, particularly Word and Excel</li><li>
Permanent authorization to work in the U.S.</li></ul>
Compensation $85,000 - 100,000 commensurate with experience
Languages
English
Education
Bachelor of Arts (BA), Bachelor of Science (BS)
Contract Type
Regular</div>

In house clinical research associate

AstraZeneca

<div>Title: Clinical Research Associate
Type: Remote - Field - Chicago/Wisconsin
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the
individual studies.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager.
Accountabilities<ul><li>
Contributes to the selection of potential investigators.</li><li>
In some countries, as required, 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 trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.</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 AZ 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 (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 LSM 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 finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ 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, CSP or ICH-GCP compliance issues to Local Management and/or 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 LSM and CQM.</li><li>
Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM 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>
Ensures compliance with AstraZeneca&rsquo;s Code of Ethics, 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>
Collaborates with local MSLs as directed by LSM or line manager.</li></ul>
Requirements:<ul><li>
Bachelors degree in related discipline, preferably in life science, or equivalent qualification (*).</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 AZ 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.</li><li>
Excellent attention to details.</li><li>
Good written and verbal communication skills.</li><li>
Good collaboration and interpersonal skills.</li><li>
Good negotiation skills.</li><li>
Ability to travel nationally/internationally as required.
</li><li>Valid driving license</li></ul>
The annual base pay for this position ranges from $112,154.40 - $168,231.60. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an &ldquo;at-will position&rdquo; and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.</div>

Clinical Research Associate - Cell Therapy

St. Jude Children's Research Hospital

<div>We are seeking a Clinical Research Associate I or II to join our team within the Center for Experimental Neurotherapeutics (CENT), a newly established clinical research program at St. Jude. The mission of CENT is to bring children with catastrophic genetic neurological disorders to St. Jude, study these conditions to better understand their clinical progression, and develop and test innovative gene-directed therapies. The selected candidate should have a strong passion for working with patients and families, an interest in contributing to a dynamic start-up environment, and a collaborative, team-oriented mindset.<div><div>
The Clinical Research Associate I or II is responsible for performing data abstraction, collection, and entry to support clinical research. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data and reports to the collaborating research organization or study sponsor.
CRA I
Job Responsibilities:<ul><li>
Assist clinical research study team(s) in general administrative activities under guidance.</li><li>
Maintain sufficient inventory of material, supplies, and equipment for performance of clinical research-related activities.</li><li>
Assist with the dispensation and receipt of study-related information (e.g., test samples, regulatory documents, etc.).</li><li>
Participate in data retrieval, reporting, and preparation of files for various studies.</li><li>
Escalate issues and problems according to set standards and processes.</li><li>
Perform other duties as assigned to meet the goals and objectives of the department and institution.</li><li>
Maintains regular and predictable attendance.</li></ul>
Minimum Education and/or Training:<ul><li>
High School Diploma/GED required.</li><li>
Bachelor's degree in relevant area preferred.</li></ul>
Minimum Experience:<ul><li>
Minimum Requirement: Experience in a research or medical/hospital environment preferred.</li></ul>
Licensure, Registration and/or Certification Required by Law:<ul><li>
None</li></ul>
Licensure, Registration and/or Certification Required by SJCRH Only:<ul><li>
None</li></ul>
Special Skills, Knowledge and Abilities:<ul><li>
Is open to any type of change or new idea presented.</li><li>
Shows eagerness to learn from different avenues.</li><li>
Addresses needs/ problems in a logical manner, using defined approaches.</li><li>
Manages own time well to plan work and meet daily task needs.</li><li>
Executes routine tasks under guidance and/ or supervision.</li><li>
Shows attention to detail, produces quality work on time.</li><li>
Has clear, concise communication in both verbal and written communication.</li><li>
Listens to requests, confirms understanding of routine needs, and provides accurate answers.</li><li>
Shares information within team as directed.</li><li>
Applies basic knowledge of clinical study support processes in delivery of routine tasks (e.g., administrative activities, documentation, inventory maintenance) with guidance.</li><li>
Follows standard operating procedures within own area of support.</li></ul>
CRA II
Job Responsibilities:<ul><li>
Act as site study coordinator conducting informed consent process as designated, and assisting with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g. CTSRC and IRB) as applicable.</li><li>
Develop, maintain, monitor, and/or share assigned/relevant documentation (e.g., investigator files, case report forms, study data).</li><li>
Perform data abstraction, collection, and entry to support clinical research.</li><li>
Prepare submission for all reportable events (e.g., adverse events, protocol variances, violations).</li><li>
Prepare detailed data reports as required.</li><li>
(As applicable) Provide patient care, education, and management (e.g., routine test conduct; assistance in clinical procedures; medication instruction, monitoring, and documentation; patient care coordination; education on protocol activities).</li><li>
Perform other duties as assigned to meet the goals and objectives of the department and institution.</li><li>
Maintains regular and predictable attendance.</li></ul>
Minimum Education and/or Training:<ul><li>
Bachelor's degree in relevant area required.</li><li>
Master's degree preferred.</li></ul>
Minimum Experience:<ul><li>
Minimum Requirement: 2+ years of experience in carrying out research preferably in healthcare settings.</li><li>
Experience Exception: Master's degree and some experience preferred.</li><li>
Experience managing cross-functional communication, including liaison between site and study teams.</li><li>
Some experience with documentation and tracking systems/processes.</li><li>
Proven performance in earlier role.</li></ul>
Licensure, Registration and/or Certification Required by Law:<ul><li>
None</li></ul>
Licensure, Registration and/or Certification Required by SJCRH Only:<ul><li>
None</li></ul>
Special Skills, Knowledge and Abilities:<ul><li>
Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes.</li><li>
Adapts quickly to changing priorities to perform as needed in his/her role.</li><li>
Remains calm when faced with changes to (and in) his/her work.</li><li>
Effectively relays understanding of diverse perspectives.</li><li>
Can handle communication upwards and downwards as needed.</li><li>
Presents information in a clear, well thought out way and tailored to the audience.</li><li>
Shows support for the new direction even when the details have not been finalized.</li><li>
Spots early indications of underperformance and takes corrective actions. Celebrates successes.</li><li>
Works with partners inside his/her function to find the best solutions that align with functional priorities. Is easy to work with to find solutions.</li><li>
Contributes to study management and research procedures by consistently executing on assigned tasks in compliance with GCP guidelines, with minimal supervision</li><li>
Applies understanding of clinical study/site operations to address requirements (e.g., study selection and set-up, clinical monitoring, risk mitigation support).</li></ul></div></div>
Compensation
In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $70,720 - $126,880 per year for the role of Clinical Research Associate II.
Explore our exceptional benefits!<div>
St. Jude is an Equal Opportunity Employer</div>
No Search Firms
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.</div>

Clinical Research Associate II

Aga Khan University

<div><div>Research Associate, Clinical Trials Unit - (2600019H)</div><div><div> 
</div><div>Research Associate, Clinical Trials Unit</div><div></div><div> 
Location: Karachi, Pakistan.</div><div>
Introduction:</div>
Aga Khan University chartered in 1983 as Pakistan's first private international university, is committed to the provision of education, research, and health care of international standards relevant to Pakistan and the region. The affiliated Aga Khan University Hospital provides state-of-the-art clinical facilities and well-equipped diagnostic services. The University currently has teaching sites in Pakistan, East Africa, the United Kingdom, and Afghanistan, and is a major component of Aga Khan Development Network.
As an equal opportunity employer, AKU believes in promoting a diverse and inclusive culture and is committed to adopt appropriate standards for safeguarding and promoting a respectful relationship with and between diverse workforce of its faculty, staff, trainees, volunteers, beneficiaries, wider communities, and other stakeholders with whom it works, including children and vulnerable adults and expects all employees/trainees and partners to share this commitment.
Clinical Trials Unit (CTU) is a Department dedicated to develop a center of excellence for high quality and high impact clinical trials both nationally &amp; internationally. The Department promotes AKU&rsquo;s vision by providing leadership, consultation, and facilitation in different phases of clinical trials in compliance with the International Standards and Good Clinical Practice (GCP) guidelines.
This is a grant-funded contractual position.<div>
Job Role / Responsibilities:</div><div>
You will be responsible to:</div><ul><li>
review clinical trial protocols, relevant SOPs, investigator brochures (IB), and other study documents</li><li>
liaise with principal investigators and/or trial coordinators for investigational product (IP) management and promptly report any discrepancies or deviations</li><li>
prepare and dispense investigational products as per protocol, institutional, and regulatory requirements</li><li>
maintain inventory for clinical investigational drug trials, including ordering, replacing, and returning study materials as required</li><li>
maintain appropriate logs for dispensing, storage, returns, and temperature monitoring, ensuring accuracy and integrity as per protocol requirements</li><li>
store investigational products as per specified conditions and maintain cold chain and temperature records</li><li>
monitor pharmacy activities daily to ensure adherence to study protocols and dispensing procedures</li><li>
maintain pharmacy trial documentation, including dispensing logs, temperature logs, and accountability records, and report any ethical concerns or deviations to the supervisor</li><li>
coordinate with sponsors, EPI centre, MMD, and warehouse for study drug procurement and develop procurement plans accordingly</li><li>
replenish study drugs as per the planned schedule</li><li>
communicate with and train staff involved in clinical investigational drug trial management</li><li>
participate in the orientation and training of new employees, pharmacy trainees, and interns</li><li>
provide drug-related information to physicians, nurses, and other healthcare professionals regarding investigational products</li><li>
attend and contribute to interdisciplinary team meetings related to clinical trials</li><li>
support randomisation processes as per protocol, if required</li><li>
complete and maintain reports, including incident reports and adverse drug reaction reports</li><li>
liaise with CTU, department of pharmacy, principal investigators, clinical trial coordinators, EPI, MMD, and trial sponsors</li><li>
consult with pharmacy personnel to obtain required expertise in support of investigational drug trials</li><li>
perform cross-functional duties including measuring blood pressure, temperature, height, weight, and pulse rate.</li></ul></div><div></div><div> 
<div>
</div><div>Eligibility Criteria / Requirements:</div><div>
You should have:</div><ul><li>
bachelor&rsquo;s degree in pharmacy with appropriate clinical/pharmacy experience</li><li>
valid registration with the Pharmacy Council of Sindh with at least two years of experience in a hospital-based pharmacy or related environment</li><li>
research and clinical experience will be considered an added advantage</li><li>
strong communication and interpersonal skills</li><li>
proficiency in the use of computers and MS Office applications</li><li>
proficiency in the written and verbal English language.</li></ul>
Comprehensive employment reference checks will be conducted.<div> 
</div></div><div>
Primary Location: Pakistan</div><div>
Organisation: Aga Khan University Pakistan</div><div>
Employee Status: Contractual</div><div>
Job Type: Standard</div><div>
Job Posting: 17/03/2026, 11:28:46 PM</div><div>
Closing Date: 23/03/2026, 1:59:00 PM</div></div>

Research Associate, Clinical Trials Unit

bioMerieux

<div>The Clinical Research Scientist (CRS) leads the execution of the clinical studies that make up the company&rsquo;s clinical evidence generation program. In this role, you will execute clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
The Clinical Research Scientist collaborates closely with cross-functional teams, including associate Clinical Research Scientists, Disease State Scientists, Biostatistics &amp; Data Management, Logistics, Medical Writers, Regional Medical Affairs teams and other stakeholders to generate impactful clinical evidence that supports the company&rsquo;s strategy. This role is crucial in maintaining our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape. 
This position can be located in either St. Louis, MO OR Salt Lake City, UT.
Primary Duties
Team and Cross Functional Leadership: 
a. Leads the study team in the execution of clinical studies to meet the Evidence Generation Plan from study synopsis to data lock and final study report 
b. Partner with internal stakeholders to lead the development, review, and finalization of clinical protocols to meet regulatory and scientific objectives 
c. Contribute to the development of the study synopsis 
d. Partner with key stakeholders to create and manage the study execution team 
e. Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Biostatistics, Program Management, external vendors, and contract research organizations (CROs) to ensure high-quality study conduct 
f. Mentor Associate Clinical Research Scientist(s) and provide guidance on clinical operations processes, study management and other study execution tasks
Study Planning, Strategy and Reporting: 
a. Develop and manage study budgets, timelines, enrollment strategies, and resourcing requirements to ensure study milestones are met 
b. Develop and manage all required plans including clinical study project plans, study execution plans, risk and risk mitigation plans, monitoring plan, and communication plans 
c. Contributes to or leads the development of abstracts/posters of study results in collaboration with study team 
d. Develop clinical study reports and/or contribute to the development of scientific publications
Study Management and Site Management: 
a. Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out for bioM&eacute;rieux initiated research studies and collaborative studies 
b. Track study progress and provide regular status reports to stakeholders 
c. Assure study metrics and budget are input to corporate systems 
d. Oversee site selection, feasibility, study startup, site activation, enrollment, and ongoing execution 
e. Oversee clinical monitoring and data integrity 
f. Update trial management systems, including timelines and budgets 
g. Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits as required 
h. Oversee clinical site activities, reference laboratories, CROs, and other external partners to ensure adherence and compliance with protocol timelines, budgets, study milestones and quality standards 
i. Manage and coordinate IRB/EC document creations and communications 
j. Manage clinical trial agreements for sites 
k. Manage study documentation and filing with electronic trial master file (eTMF) platforms
Regulatory Compliance: 
a. Follow Corporate (e.g., SOP&rsquo;s) and local/regional regulatory requirements 
b. Participate in the review and revision of Clinical Operations Standard Operating Procedures (SOPs) to assist Medical Affairs leadership with continuous process improvement initiatives
Quality and Compliance: 
a. Identify and mitigate risks throughout the clinical trial lifecycle 
b. Assure a quality plan is in place
Data Management: 
a. Oversee and manage electronic data capture (EDC) systems 
b. Oversee data collection activities, compliance, and inspection readiness 
c. Oversee electronic trial master file (eTMF) platforms to ensure data integrity and regulatory compliance
Communication: 
a. Lead internal and external study meetings with relevant stakeholders 
d. Organize and drive study meetings and other study activities as assigned 
e. Participate in core team meetings to provide clinical insights and contribute to strategic decision-making 
f. Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders
Vendor management: 
a. Negotiate contracts and budgets in partnership with the legal team 
b. Manage clinical trial agreements with external vendors 
c. Manage vendor performance according to contract
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.
Experience<ul><li>
Bachelor's Degree required in a scientific, medical, or healthcare discipline</li><li>
2+ years of professional related experience in clinical trial management, preferably in diagnostics or medical device required.</li><li>
Certifications including ACRP-CP or ACRP-PM a plus.
</li><li>Excellent knowledge of clinical trial processes, systems, and tools (e.g., CTMS, EDC, eTMF), with the ability to oversee quality, data integrity, and inspection readiness.
</li><li>Proven leadership and stakeholder-management capabilities, with the ability to influence without authority and build strong relationships across functions and with external partners.
</li><li>Experience negotiating clinical research contracts and budgets
</li><li>Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
</li><li>Experience managing all major aspects of strategic planning, organization, implementation, and delivery of clinical studies.
</li><li>Understanding the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO)
</li><li>Proven track record writing clinical study plans and study protocols
</li><li>Experience with the study budget oversight, risk mitigation, management of timelines, deliverables, and milestones
</li><li>Experience negotiating clinical research contracts and budgets with Investigators and sites
</li><li>Experience with electronic clinical trial systems and clinical data review
</li></ul>Knowledge, Skills, &amp; Abilities<ul><li>
Consistently upholds and reflects the core ethical principles and values that bioM&eacute;rieux promotes.</li><li>
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives</li><li>
Effective Presentation Skills - including the ability to present technical data</li><li>
Solution oriented in the face of conflict</li><li>
Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently</li><li>
Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.</li><li>
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
</li><li><ul><li>Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently</li></ul></li><li>
Functionally Required Knowledge, Skills, and Abilities
</li><li><ul><li>Ability to manage budget, timelines and multiple projects simultaneously</li><li>
Ability to learn new products and adjust to changing research directions</li></ul></li></ul><div>
The estimated salary range for this role is between $80,000 and $116,700. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux&rsquo;s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate&rsquo;s experience and will be presented in writing at the time of the offer.</div><div>
In addition, bioM&eacute;rieux offers a competitive Total Rewards package that may include:</div><ul><li>A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options</li><li>Company-Provided Life and Accidental Death Insurance</li><li>Short and Long-Term Disability Insurance</li><li>Retirement Plan including a generous non-discretionary employer contribution and employer match.</li><li>Adoption Assistance</li><li>Wellness Programs</li><li>Employee Assistance Program</li><li>Commuter Benefits</li><li>Various voluntary benefit offerings</li><li>Discount programs</li><li>Parental leaves</li></ul><div>
</div><div>
#LI-US</div></div>

Clinical Research Scientist

Thermo Fisher Scientific

<div>Work Schedule
Environmental Conditions
Job Description
Join Us as a Clinical Research Associate (Level II) &ndash; IVD and Clinical &ndash; Make an Impact at the Forefront of Innovation. 
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. 
 
As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. The IVD Clinical Research Associate (CRA) is responsible for monitoring clinical trial testing sites to ensure compliance with Clinical Performance Study Protocol (CPSP), protocol, ICH-GCP guidelines, SOPs, and applicable regulatory requirements. The CRA serves as the primary liaison between the clinical lead and investigational testing sites and ensures the integrity, quality, and timely delivery of IVD testing data.
As a Clinical Research Associate (Level II), you'll also conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. 
What You&rsquo;ll Do:<ul><li>Perform testing site initiation, monitoring visits and close-out, in accordance with the Monitoring Plan.</li><li>Ensure CPSP/protocol adherence and IVD safety and quality.</li><li>Assess adequacy of site resources, laboratory equipment, and infrastructure</li><li>Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</li><li>Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</li><li>Train testing site staff on CPSP, protocol, EDC, safety reporting, testing devices and study procedures.</li><li>Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.</li><li>Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>Responds to company, client and applicable regulatory requirements/audits/inspections.</li><li>Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</li><li>Contributes to other project work and initiatives for process improvement, as required.</li></ul> 

Education and Experience Requirements: 
<ul><li>Bachelor's degree in Microbiology or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.</li><li>Valid driver's license where applicable.</li></ul>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 
 
Knowledge, Skills and Abilities: 
<ul><li>Proven clinical monitoring skills</li><li>Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</li><li>Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth `investigation for appropriate root cause analysis and problem solving</li><li>Ability to manage Risk Based Monitoring concepts and processes</li><li>Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>Good organizational and time management skills</li><li>Effective interpersonal skills</li><li>Attention to detail</li><li>Ability to remain flexible and adaptable in a wide range of scenarios</li><li>Ability to work in a team or independently as required</li><li>Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>Fluency in Arabic and good English language and grammar skills</li><li>Good presentation skills</li></ul> 

Working Conditions and Environment: 
<ul><li>Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.</li><li>Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.</li><li>Exposure to biological fluids with potential exposure to infectious organisms.</li><li>Personal protective equipment required such as protective eyewear, garments and gloves.</li><li>Exposure to fluctuating and/or extreme temperatures on rare occasions</li></ul><div><div><div><div><div><ul><li>Please submit your CV in English
</li></ul></div></div></div></div></div><div><div>Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.</div></div></div>

CRA II - IVD and Clinical

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