clinical trials manager

Retinal Consultants

**Overview:** We are seeking a dedicated Study Manager to join our team. The ideal candidate will have experience in clinical trials management and possess strong knowledge of clinical development processes. **Responsibilities:** - Manage and oversee clinical trials from initiation to completion - Ensure compliance with HIPAA regulations and other relevant standards - Review and maintain accurate documentation throughout the study - Conduct vital signs assessments and phlebotomize when necessary - Collaborate with clinical laboratory staff to ensure accurate results - Implement compliance management strategies to uphold study integrity **Experience:** - Proven experience in clinical trials management - Familiarity with HIPAA regulations and compliance standards - Ability to review and interpret clinical trial documentation - Knowledge of phlebotomy techniques - Strong understanding of clinical development processes This position offers the opportunity to work in a dynamic environment where you can contribute to cutting-edge research initiatives. If you are passionate about clinical trials and ensuring high-quality study outcomes, we encourage you to apply.Job Type: Part-timePay: $20.00 - $25.00 per hourBenefits:<ul><li>Paid time off</li></ul>Work Location: In person

Ophthalmology Clinical Trial Coordinator

<div>Job Description
Are you passionate about driving high‑quality clinical trials and building strong partnerships with investigators? Do you thrive in a role that combines end‑to‑end study ownership, cross‑functional leadership, and strategic impact?
We are looking for a Clinical Research Manager (CRM) to lead the operational delivery of clinical trials at country (and potentially cluster) level, ensuring excellence in execution, compliance, and stakeholder collaboration.<h2 class="jobSectionHeader">
Key Responsibilities</h2><ul><li>
Serve as the main point of contact for assigned protocols, representing country operations within global Clinical Trial Teams</li><li>
Lead end‑to‑end project management of clinical trials&mdash;from feasibility and site selection through execution and close‑out</li><li>
Ensure compliance with ICH/GCP, local regulations, internal policies, and safety reporting requirements</li><li>
Drive study performance by proactively planning, tracking, and resolving risks related to timelines, quality, and recruitment</li><li>
Lead and coordinate local study teams, acting as protocol expert and supporting CRAs and other country roles</li><li>
Review monitoring visit reports, identify performance gaps, and escalate issues as needed</li><li>
Conduct quality control visits when required</li><li>
Develop and execute local risk management plans for assigned studies</li><li>
Ensure accurate and timely use of CTMS, eTMF, and other key systems</li><li>
Build strong, trust‑based relationships with investigators, vendors, and external partners</li><li>
Share best practices across studies, countries, and clusters</li><li>
Contribute to local and regional clinical operations strategy in collaboration with internal stakeholders</li></ul><h3 class="jobSectionHeader">
Experience &amp; Education</h3><ul><li>
Bachelor&rsquo;s degree in Science or equivalent (advanced degree preferred)</li><li>
5&ndash;6 years of experience in clinical research</li><li>
CRA experience is an advantage</li></ul><h3 class="jobSectionHeader">
Core Skills</h3><ul><li>
Strong project and site management expertise</li><li>
Solid understanding of clinical trial planning, execution, and performance metrics</li><li>
Excellent knowledge of the local regulatory environment</li><li>
Ability to manage multiple studies and priorities simultaneously</li><li>
Fluent in English and local language (Arabic), with strong written and verbal communication skills</li></ul><h3 class="jobSectionHeader">
Leadership &amp; Behaviors</h3><ul><li>
Proven ability to lead without direct authority and influence cross‑functional teams</li><li>
Strong problem‑solving and risk‑mitigation mindset</li><li>
Skilled in navigating complex situations such as recruitment challenges, compliance issues, and resource constraints</li><li>
Collaborative, culturally aware, and effective in remote/virtual environments</li><li>
Professional, diplomatic, and confident when engaging with investigators and stakeholders</li></ul>
Required Skills:
Clinical Data Management, Clinical Research, Clinical Site Management, Clinical Trial Management Processes, Clinical Trials Operations, Good Clinical Practice (GCP), Planning, Project Management, Quality Management, Risk Management, Stakeholder Engagement
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
04/27/2026<ul><li>A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
</li></ul> 
Requisition ID:R392298</div>

Clinical Research Manager

NexGen Research

Overview We are seeking a dedicated and experienced Clinical Research Site Manager to work onsite at our Lima, OH location. The Clinical Research Site Manager will oversee the management of clinical trials at our research facility. The ideal candidate will have a strong background in clinical research, excellent supervisory skills, and a thorough understanding of FDA regulations and Good Clinical Practice (GCP). This role is essential in ensuring the successful execution of clinical trials while maintaining compliance with all regulatory requirements, play a key role in driving site growth, staff development, and sponsor satisfaction.Duties<ul><li>Oversee day-to-day site operations and ensure studies are conducted per protocol, GCP, and regulatory requirements.</li><li>Supervise and mentor Clinical Research Coordinators, Regulatory Specialists, and support staff.</li><li>Coordinate cross-functional activities across recruiting, scheduling, source documentation, and data entry to maintain timelines.</li><li>Collaborate with PIs, sub-investigators, and sponsors to ensure study milestones are achieved.</li><li>Monitor key site metrics (screening, randomization, query resolution, data entry timeliness, retention).</li><li>Manage site budgets, invoicing, and sponsor payments with support from finance and leadership.</li><li>Support feasibility assessments, pre-site selection visits, and business development initiatives.</li><li>Develop and refine SOPs and workflows to improve efficiency and compliance.</li><li>Serve as point of contact for sponsor/CRO monitors and auditors.</li></ul>Qualifications<ul><li>Minimum 3&ndash;5 years of clinical research experience, including 1&ndash;2 years in a leadership or management role (Site Manager, Lead CRC, or equivalent).</li><li>Proven experience in supervising clinical research teams or managing clinical trials.</li><li>Strong knowledge of medical terminology, FDA regulations, GCP, and compliance management practices.</li><li>Experience in data management, including familiarity with EMR systems and statistical software.</li><li>Excellent analytical skills with the ability to interpret complex data sets effectively.</li><li>Demonstrated ability to monitor patients effectively throughout the trial process.</li><li>Familiarity with documentation review processes and adherence to regulatory standards in clinical research. Join our team as a Clinical Research Site Manager where you will play a crucial role in advancing medical research while ensuring the highest standards of patient care and compliance are met.</li><li>Bachelor&rsquo;s degree in health sciences, nursing, or related field (advanced degree preferred).</li><li>Background in nursing or related healthcare field is preferred, along with clinical laboratory experience.</li><li>Excellent organizational, leadership, and communication skills.</li><li>Ability to manage multiple studies and teams in a fast-paced environment.</li><li>Experience with CTMS, eSource, and eRegulatory systems preferred.</li><li>CCRP, CCRA, or ACRP certification a plus.</li></ul>Compensation<ul><li>Base Salary: $70,000 &ndash; $80,000 per year (commensurate with experience)</li><li>Performance Bonus: Quarterly incentive based on measurable site metrics including:</li><li>Patient enrollment and retention goals</li><li>Timely data entry and query resolution</li><li>Study close-out and audit readiness</li></ul>Benefits<ul><li>Paid Time Off (PTO) and paid holidays</li><li>Health, dental, and vision insurance (employer contribution)</li><li>401(k) retirement plan with employer match</li><li>Tuition reimbursement and professional development support</li><li>Opportunity for advancement to Director of Site Operations with expanded responsibilities</li></ul>Why Join NexGen Research<ul><li>Physician-led organization with direct involvement in clinical and operational decisions</li><li>Collaborative, growth-oriented culture</li><li>Exposure to diverse therapeutic areas and sponsors</li><li>Opportunity to shape a fast-scaling research network and lead future site expansions</li></ul>Job Type: Full-timeBase Pay: $70,000.00 - $80,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Clinical Research Site Manager

Solace Clinical Research

Job Summary We are seeking a dynamic and highly organized Clinical Research Site Manager to lead and oversee the daily operations of our clinical trial site. In this pivotal role, you will coordinate all aspects of clinical trials, ensuring compliance with regulatory standards, maintaining high-quality documentation, and fostering a patient-centered environment. Your leadership will drive the successful execution of research studies, facilitate effective communication among team members, and uphold the integrity of data collection and management. This position offers an exciting opportunity to contribute to groundbreaking medical research while supporting the advancement of healthcare solutions.Responsibilities<ul><li>Supervise and coordinate the activities of clinical research staff, including nurses, coordinators, and laboratory personnel, ensuring seamless trial operations</li><li>Manage patient recruitment, screening, enrollment, and ongoing monitoring to ensure adherence to study protocols and regulatory requirements</li><li>Oversee data collection processes, review source documents for accuracy, and ensure proper documentation in accordance with ICH GCP standards and FDA regulations</li><li>Maintain compliance with HIPAA regulations and ensure confidentiality of patient information throughout all trial activities</li><li>Review clinical documentation such as case report forms (CRFs), laboratory results, vital signs, and adverse event reports for completeness and accuracy</li><li>Monitor clinical laboratory procedures including blood sampling, phlebotomy, and specimen handling to ensure quality standards are met</li><li>Utilize electronic medical record (EMR) systems and statistical software for data management, analysis, and reporting purposes</li><li>Ensure adherence to CDISC standards for data formatting and reporting in clinical trials</li><li>Conduct regular site audits to verify compliance with protocol requirements and regulatory guidelines</li><li>Facilitate training sessions on Good Clinical Practice (GCP), FDA regulations, and study-specific procedures for staff members</li></ul>Qualifications<ul><li>Proven supervising experience in a clinical research environment or healthcare setting</li><li>Strong knowledge of clinical trials management, including patient monitoring and data collection techniques</li><li>Familiarity with medical terminology, clinical laboratory procedures, and blood sampling techniques</li><li>Experience with EMR systems, statistical software, and data management tools used in clinical research</li><li>In-depth understanding of FDA regulations, ICH GCP guidelines, HIPAA compliance, and CDISC standards</li><li>Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent is required; additional certifications such as an ICH GCP certificate are preferred</li><li>Background in nursing or clinical laboratory work is advantageous</li><li>Excellent analysis skills with attention to detail for reviewing documentation and ensuring protocol adherence</li><li>Ability to lead teams effectively while maintaining a positive work environment</li></ul>Join us in advancing innovative healthcare solutions by managing impactful clinical research studies. Your expertise will help shape the future of medicine while supporting a collaborative team dedicated to excellence in clinical development.Pay: $20.00 - $38.00 per hourBenefits:<ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul>Work Location: In person

Hawaii Pacific Neuroscience

Job Overview We are seeking a dynamic and detail-oriented Clinical Research Coordinator to join our team and drive forward innovative clinical trials. In this pivotal role, you will coordinate all aspects of clinical research studies, ensuring compliance with regulatory standards, managing data collection, and maintaining seamless communication between research teams, participants, and regulatory bodies. Your energetic approach will help accelerate the development of new therapies and improve patient outcomes. This paid position offers an exciting opportunity to contribute to cutting-edge medical research in a collaborative environment dedicated to excellence.Duties<ul><li>Oversee the planning, implementation, and management of clinical trials in accordance with FDA regulations, ICH GCP guidelines, and institutional policies</li><li>Recruit, screen, and monitor study participants, ensuring adherence to protocol and safety standards</li><li>Review and verify all study documentation for accuracy, completeness, and compliance with regulatory requirements</li><li>Collect, record, and manage clinical data using electronic Medical Record (EMR) systems and adhere to CDISC standards for data formatting</li><li>Conduct patient assessments including vital signs, blood sampling (phlebotomy), and monitoring of clinical laboratory results</li><li>Supervise research staff and coordinate activities related to clinical trials management, including training on Good Clinical Practice (GCP) procedures</li><li>Ensure compliance with HIPAA regulations to protect patient privacy and confidentiality at all times</li></ul>Skills<ul><li>Proven supervising experience in clinical research settings with strong leadership capabilities</li><li>Extensive knowledge of clinical trials management processes from protocol development to data analysis</li><li>Proficiency in medical terminology, blood sampling techniques, and clinical laboratory procedures</li><li>Skilled in reviewing documentation such as consent forms, case report forms (CRFs), and regulatory submissions</li><li>Ability to monitor patients effectively while maintaining high standards of care and safety protocols</li><li>Experience with statistical software for data analysis and interpretation of trial results</li><li>Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance, and CDISC standards for data management</li><li>Clinical laboratory experience including blood sampling techniques such as phlebotomy</li><li>Strong understanding of clinical development phases and research methodologies</li><li>Certification in GCP from a recognized issuer (such as ICH GCP certificate) or equivalent certification in Good Clinical Practice (GCP) applicable in California or other regions</li><li>Knowledge of EMR systems for efficient data entry and retrieval during trial conduct</li><li>Excellent analysis skills for interpreting complex clinical data sets accurately</li><li>Ability to manage multiple projects simultaneously while ensuring strict adherence to compliance management protocols</li></ul>Join us to be part of a passionate team dedicated to advancing medical science! Your expertise will directly impact the development of new treatments while providing invaluable support to patients participating in groundbreaking research. We value your commitment to excellence and look forward to welcoming a motivated professional eager to make a difference.Pay: $62,400.00 - $68,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee discount</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>Professional development assistance</li><li>Retirement plan</li><li>Vision insurance</li></ul>Work Location: In person

Clinical Research Coordinator

Allegheny Health Network

<div><h2 class="jobSectionHeader">Company :
</h2>Allegheny Health Network
<h2 class="jobSectionHeader">Job Description :
</h2>GENERAL OVERVIEW:
This job plans, coordinates, and manages the activities associated with the initiation and completion of clinical trials, sponsored by internal, industry, foundation, and/or Federal funding sources. Maintains compliance with all regulatory bodies associated with human subject research.
ESSENTIAL RESPONSIBILITIES:
<ul><li>Interfaces with clinical staff to identify patients eligible for clinical trials. Provides in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (30%)
</li><li>Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure that they are informed prior to obtaining written consent. Completes required follow-up and active patient monitoring per study protocol. (30%)
</li><li>Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies. (15%)
</li><li>Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies. (15%)
</li><li>Performs other duties as assigned or required. (10%)
</li></ul>QUALIFICATIONS:
Minimum
<ul><li>Associate's degree, RN, or equivalent research experience.
</li><li>1-3 years&rsquo; related experience.
</li></ul>Preferred
<ul><li>Bachelor&rsquo;s Degree.
</li><li>Current research-related certification from accredited program such as The Association of Clinical Research Professional (ACRP), e.g. Certified Clinical Research Coordinator (CCRC), ACRP Certified Professional (ACRP-CP) or The Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professionals (CCRP).
</li><li>Driver's license may be required depending on facility requirements.
</li></ul>Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.
 
 
Compliance Requirement : This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies. 
 
As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company&rsquo;s Handbook of Privacy Policies and Practices and Information Security Policy.
 
 
Furthermore, it is every employee&rsquo;s responsibility to comply with the company&rsquo;s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.
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Clinical Research Coordinator - Full Time - Day Shift - AGH

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $100,000-$110,000</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

The candidate will be an integral member of the senior leadership team within the Clinical Protocol &amp; Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). Responsibilities include but are not limited to: coordinating the data management activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Clinical Research Coordinators (CRCs) and Data Coordinators(DCs); creating and promoting professional development opportunities (both internally and externally) for staff; implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships and outcomes with private industry and other external agencies.

The Clinical Research Manager reports directly to the Assistant Director, Clinical Research Operations.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

STAFFING
<ul>
<li>Posts/justifies new and replacement positions, screens applicants</li>
<li>On-boards and trains staff (protocol, university, departmental training)</li>
<li>Liaises with the HICCC HR representative for scheduling medical surveillance, JCAHO, and other HR-related functions</li>
<li>Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals)</li>
</ul>
SUPERVISION
<ul>
<li>Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations</li>
<li>Determines CRC and DC workloads and protocol assignments</li>
<li>Assures the subject data collected by the CRCs is organized and submitted in a timely manner</li>
<li>Develops quality control mechanisms to ensure accurate data reporting</li>
<li>Assists with CRF development, accuracy, and implementation for investigator initiated trials</li>
<li>Ensures CRC&rsquo;s are adequately prepared for and successfully manage all monitoring and/or auditing visits
</li>
</ul>PROTOCOL/DISEASE BASE TEAM MANAGEMENT
<ul>
<li>Provides protocol management and research expertise by participating in discussions at disease team and collaborative research meetings, ensuring operational feasibility, compliance, and strategic alignment with CPDM and Cancer Center goals.</li>
<li>Leads ongoing assessment of trials within the portfolio to evaluate feasiblity, accrual trends, and resource utilization. Implements priority scoring and portfolio review processes to ensure staffing and support are aligned with institutional priorities and study performance.</li>
Organizes and coordinates project activities, collaborating with multidisciplinary teams - including investigators, research nurses, coordinators and regulatory staff <li>- to ensure timely completion of study start-up, activation, and conduct.</li>
<li>Represents the department at conferences and meetings, maintaining effective communication channels between clinical, research, and administrative stakeholders to promote consistent study management, issue resolution, and operational best practices.</li>
</ul>
FINANCE MANAGEMENT
<ul>
<li>Prepares and reviews study budgets for submission, negotiation, and ongoing financial monitoring to ensure accuracy, compliance, and alignment with departmental standards.</li>
<li>Monitors, reports, and interprets variances to approved budgets. Collaborates with the Assistant Director to develop and execute action plans that address financial gaps and optimize resource utilization. Uses forecasting tools to project financial outcomes and proactively identify risks and opportunities.</li>
<li>Implements strategies to support financial stability and operatinal efficiency across assigned studies and departmental functions. Ensures financial practices align with institutional priorities, long-term sustainability goals, and portfolio management objectives.</li>
</ul>
DEPARTMENT INITIATIVES
<ul>
<li>Assist the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs).</li>
<li>Develop standardized forms, study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, provide appropiate staff updates, in-services, trainings, etc.</li>
</ul>
OTHER
<ul>
<li>Performs other related duties as assigned.</li>
</ul>
Minimum Qualifications
<ul>
<li>Bachelor&rsquo;s Degree or equivalent in education, training and experience, plus 4 years of related experience.</li>
</ul>
Preferred Qualifications
<ul>
<li>Certification as a Clinical Research Professional through a national accrediting body such as ACRP and/or SoCRA.</li>
</ul>
Other Requirements
<ul>
<li>Minimum one year of supervisory experience.</li>
<li>Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.</li>
<li>Excellent interpersonal and organizational skills.</li>
<li>Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).</li>
</ul>
Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

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Clinical Research Coordinator - Full Time - Day Shift - AGH

Clinical Research Manager