clinical research associate

Mix Talent

<div>
 
 Clinical Research Associate | Sponsor-Side | Biologics
 
 
 
 We&rsquo;re partnering with an innovative, cGMP-certified regenerative biologics company advancing extracellular vesicle platform technology, and they&rsquo;re hiring a Clinical Research Associate to support growing clinical programs.
 
 
 This is a high-impact, field-facing role with strong sponsor visibility.
 
 
 What You&rsquo;ll Do:
 
 
 <ul>
 <li>
 Conduct site evaluation, initiation, monitoring &amp; closeout visits (on-site + remote)
 </li>
 <li>
 Ensure GCP, FDA &amp; ICH compliance
 </li>
 <li>
 Review source data, safety reporting &amp; EDC entries
 </li>
 <li>
 Oversee IMP accountability &amp; pharmacy compliance
 </li>
 <li>
 Support protocol development and study documents
 </li>
 <li>
 Mentor junior CRAs and collaborate cross-functionally
 
 
 </li>
 </ul>
 What We&rsquo;re Looking For:
 
 
 <ul>
 <li>
 3+ years CRA experience (on-site + remote)
 </li>
 <li>
 Strong GCP &amp; FDA regulatory knowledge
 </li>
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 Preferred: CRA monitoring experience within a biotech or biopharma sponsor organization
 </li>
 <li>
 Biologics experience a plus
 </li>
 <li>
 Willingness to travel up to 50%+
 
 
 </li>
 </ul>
 If you&rsquo;re looking for a visible, growth-oriented CRA role within an innovative biologics organization, let&rsquo;s connect
 
 
 Job Identifier: #9817
 
 
</div>

Clinical Research Associate

ICON plc

<div>Clinical Research Associate - Early Development Multi-Therapeutic - Regional (major hub) 
 
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. 
 
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 
 
As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. 
 
What You Will Do:
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.
 
 
Key responsibilities include:
<ul><li>Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li>
<li>Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li>
<li>Collaborating with investigators and site staff to facilitate smooth study conduct.</li>
<li>Performing data review and resolution of queries to maintain high-quality clinical data.</li>
<li>Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li> 
</ul> 
Your Profile:
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills.
 
 
Required qualifications and experience:
<ul><li>Bachelor's degree in a scientific or healthcare-related field.</li>
<li>Minimum of 2 years of experience as a Clinical Research Associate.</li>
<li>In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li>
<li>Strong organizational and communication skills, with attention to detail.</li>
<li>Ability to work independently and collaboratively in a fast-paced environment.</li>
<li>Willingness to travel as required (approximately 60%)</li> 
</ul> 
Employment with ICON is contingent upon having the legal right to work in the country where the role is based. 
 
Rewards &amp; Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. 
 
Benefits may include:
<ul><li>Competitive base salary and performance related incentives</li>
<li>Health and wellbeing programmes including medical, dental, and vision coverage where applicable</li>
<li>Retirement and pension plans</li>
<li>Life assurance and disability coverage</li>
<li>Employee assistance programmes and wellbeing resources</li>
<li>Learning and development opportunities through structured training and career pathways</li> 
</ul> 
Benefits may vary depending on role and location. 
 
Visit our careers site to read more about the benefits ICON offers. 
 
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. 
 
If you require reasonable accommodations during the recruitment process, please let us know or submit a request .
Are you a current ICON Employee?</div>

Intellectt Inc

<div>
 
 The Clinical Research Associate (CRA) serves as a sponsor-side clinical operations representative responsible for oversight of investigational sites and support of high-quality study execution across Phase 1 oncology trials (required) plus other therapeutic areas monitoring oversight a plus. This role combines traditional site monitoring responsibilities with broader sponsor oversight activities, including identification of operational and quality risks, collaboration with CRO partners and vendors, and proactive escalation of issues that may affect subject safety, data integrity, protocol compliance, or study timelines. The CRA is expected to apply strong clinical judgment in early-phase oncology settings, including dose-escalation and complex treatment protocols, while building effective relationships with sites and internal cross-functional teams. Experience monitoring National Cancer Institute (NCI) studies, cooperative group studies, or other academically complex oncology trials is strongly preferred. This is a contract traveling CRA position, as needed.
 
 
 
 
 
 
 Primary Responsibilities:
 
 
 
 &bull; Serve as the sponsor-side point of contact for assigned sites, providing direct oversight of site performance, protocol execution, and overall study conduct throughout the trial lifecycle.
 
 
 &bull; Conduct on-site and remote monitoring activities for Phase 1 oncology studies, including site qualification, initiation, routine monitoring, and closeout visits, in alignment with the monitoring plan, sponsor SOPs, ICH/GCP, and applicable regulations.
 
 
 &bull; Provide sponsor oversight of critical study processes, including informed consent, eligibility confirmation, treatment administration, dose-escalation decisions, safety reporting, investigational product handling, protocol deviations, and data quality.
 
 
 &bull; Evaluate site performance, operational readiness, and quality trends using monitoring observations, study metrics, and site interactions to identify actual or emerging risks.
 
 
 &bull; Escalate significant site issues, quality concerns, and compliance risks in a timely manner, and partner with the Clinical Trial Manager and broader study team on mitigation strategies and follow-up actions.
 
 
 &bull; Collaborate closely with CRO monitors, vendors, data management, medical monitoring, pharmacovigilance, clinical scientists, and study management to ensure alignment on site status, issues, and study priorities.
 
 
 &bull; Provide sponsor-level oversight of CRO-delivered monitoring activities, as applicable, including review of monitoring quality, timeliness of follow-up, issue escalation, and adequacy of site action plans.
 
 
 &bull; Review source-oriented and site-level information to confirm that subject safety, protocol compliance, and key study endpoints are being managed appropriately, with particular attention to the complexity of early-phase oncology trials.
 
 
 &bull; Support study start-up and maintenance activities by contributing to site feasibility, site activation readiness, training, enrollment oversight, and ongoing site engagement.
 
 
 &bull; Track and follow critical site issues, protocol deviations, data queries, action items, and inspection readiness activities to resolution, ensuring appropriate documentation and communication across stakeholders.
 
 
 &bull; Prepare and/or review monitoring documentation, visit reports, follow-up communications, and study oversight documentation to ensure accuracy, consistency, and compliance with sponsor expectations.
 
 
 &bull; Contribute to audit and inspection readiness by ensuring site-facing and sponsor oversight activities are documented appropriately and that issues are identified, trended, escalated, and resolved in a timely manner.
 
 
 &bull; Build strong working relationships with investigators, research nurses, study coordinators, pharmacists, and site leadership while maintaining clear sponsor expectations for quality and performance.
 
 
 &bull; Apply prior oncology monitoring experience to assess patient safety considerations, site capabilities, protocol complexity, and operational execution in Phase 1 and other early-phase oncology settings.
 
 
 &bull; Experience monitoring National Cancer Institute (NCI) studies, cooperative group studies, or federally sponsored oncology trials is a strong plus, particularly in environments with complex institutional processes and academic site infrastructure.
 
 
 &bull; Travel to investigative sites as required to support sponsor-side field monitoring and oversight responsibilities.
 
 
 This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
 
 
 
 
 
 
 Qualifications, Knowledge, Skills and Abilities:
 
 
 
 &bull; Bachelor&rsquo;s degree in life sciences, nursing, pharmacy, or a related scientific field preferred.
 
 
 &bull; Minimum of 5 years of clinical monitoring experience, with strong oncology monitoring experience required.
 
 
 &bull; Direct Phase 1 oncology monitoring experience is required, including experience with dose-escalation studies, complex eligibility and safety assessments, and early-phase operational challenges.
 
 
 &bull; Prior experience in a sponsor-side or sponsor-dedicated CRA role is preferred; candidates should demonstrate the ability to operate with a sponsor mindset and exercise sound judgment beyond routine monitoring activities.
 
 
 &bull; Experience monitoring NCI-sponsored studies, cooperative group studies, or academic oncology research networks is preferred.
 
 
 &bull; Strong working knowledge of ICH/GCP guidelines, FDA regulations, and sponsor oversight expectations, including the ability to recognize and escalate risks related to subject safety, data integrity, and protocol compliance.
 
 
 &bull; Experience working with CRO partners and cross-functional study teams, with the ability to communicate clearly, influence effectively, and drive issue resolution across multiple stakeholders.
 
 
 &bull; Experience with EDC systems, CTMS, eTMF, and study tracking tools, with the ability to use study information and metrics to assess site status and support oversight.
 
 
 &bull; Strong written and verbal communication skills, with the ability to clearly document findings, synthesize issues, and communicate risks and recommendations to internal and external stakeholders.
 
 
 &bull; Demonstrated ability to identify issues, apply critical thinking, drive follow-up to resolution, and support inspection-ready study conduct.
 
 
 &bull; Willingness and ability to travel regularly for on-site monitoring and sponsor oversight activities.
 
 
 
 
 
 it is now defined as a 40-hour-a-week job!
 
</div>

Spaulding Clinical

<div>Job Summary:<div>
The Senior Clinical Research Associate (Senior CRA) is responsible for performing monitoring and site management activities to ensure that assigned clinical research studies are conducted and reported in accordance with the study protocol, applicable regulations and guidelines, Good Clinical Practice, ICH requirements, sponsor requirements, and Spaulding Clinical SOPs. This role supports Phase I clinical pharmacology studies by overseeing site conduct, documentation quality, recruitment progress, data integrity, issue resolution, and inspection readiness while reporting to the Clinical Team Lead.
The Senior CRA serves as a senior monitoring and site management resource for assigned studies and may perform selection, initiation, interim monitoring, and close-out visits in accordance with contracted scope of work, monitoring plans, and project requirements. The role works closely with sites, sponsors, Project Management, Clinical Operations, Regulatory, Data Management, Quality Assurance, and other cross-functional stakeholders to support compliant study execution, timely deliverables, and proactive escalation of quality, operational, recruitment, and site performance risks.</div>
Essential Duties and Responsibilities:
Study Monitoring and Clinical Oversight<ul><li>
Perform site monitoring visits, including site selection, site initiation, interim monitoring, and close-out visits, in accordance with contracted scope of work, monitoring plans, project requirements, Good Clinical Practice, applicable regulations, and sponsor expectations.</li><li>
Review study conduct, source documentation, case report forms, regulatory documents, essential documents, and applicable study records for accuracy, completeness, timeliness, and protocol compliance.</li><li>
Verify that study activities are conducted in accordance with protocol requirements, informed consent, GCP, applicable regulations, sponsor expectations, and Spaulding Clinical SOPs.</li><li>
Identify, document, communicate, and escalate protocol deviations, documentation deficiencies, quality concerns, participant safety concerns, and operational risks in a timely manner.</li><li>
Support timely resolution of monitoring findings, data discrepancies, action items, audit observations, and study team follow-up items.</li><li>
Maintain a strong working knowledge of Phase I unit operations, clinical pharmacology procedures, study-specific requirements, source documentation expectations, and sponsor delivery expectations.</li><li>
Support review of study-specific tools, worksheets, source templates, visit schedules, and documentation practices to promote consistency, completeness, and inspection readiness.</li><li>
Participate in study meetings, sponsor calls, internal project meetings, and cross-functional discussions as the CRA representative or clinical operations quality resource.</li><li>
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations, questions, action items, and issues.</li><li>
Evaluate the quality and integrity of study site practices related to proper protocol conduct, participant safety, data integrity, informed consent, and adherence to applicable regulatory requirements; escalate quality issues as appropriate.</li><li>
Work with sites and study teams to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability and support enrollment goals.</li><li>
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution; may support the study start-up phase as assigned.</li></ul>
Protocol, Regulatory, and GCP Compliance<ul><li>
Maintain current knowledge of Good Clinical Practice, ICH guidelines, FDA regulations, applicable laws, ethical standards, and internal SOPs relevant to clinical trial conduct.</li><li>
Review assigned protocols, amendments, informed consent documents, manuals, monitoring plans, and study-specific instructions to ensure thorough understanding of study requirements.</li><li>
Support protocol training and study readiness activities by helping confirm that appropriate staff understand study-specific documentation, timing, procedural, and escalation requirements.</li><li>
Partner with Quality Assurance and operational leaders to support audit readiness, inspection readiness, CAPA activities, root cause analysis, and quality improvement efforts as needed.</li><li>
Ensure clinical research documentation supports sponsor review, audits, regulatory inspections, and internal quality expectations.</li><li>
Recognize and escalate clinical practice concerns, participant safety issues, consent concerns, data integrity concerns, and potential compliance risks promptly and professionally.</li></ul>
Study Documentation, Data Quality, and Issue Resolution<ul><li>
Evaluate study documentation and data collection practices to help ensure accurate, attributable, legible, contemporaneous, original, and complete records.</li><li>
Support data cleaning activities by assisting with query review, source-to-database verification, discrepancy follow-up, and communication with study team members.</li><li>
Track assigned action items, findings, risks, and documentation issues through resolution using applicable tools, trackers, and systems.</li><li>
Prepare accurate monitoring reports, visit summaries, follow-up letters, action item trackers, and other CRA deliverables in accordance with timelines and quality standards.</li><li>
Support Trial Master File and/or study file completeness by reviewing essential documents and identifying missing, incomplete, or outdated documentation.</li><li>
Ensure copies and/or originals, as required, of site documents are available for filing in the Trial Master File and verify that the Investigator's Site File is maintained in accordance with Good Clinical Practice and applicable regulatory requirements.</li><li>
Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular monitoring visit reports, generating follow-up letters, and completing other required study documentation within required timelines.</li><li>
Assist Project Management and study teams with study startup, conduct, closeout, and lessons-learned activities as assigned.</li></ul>
Cross-Functional Collaboration and Sponsor Support<ul><li>
Partner with Project Management to support study timelines, risk management, sponsor communication, issue escalation, and successful project delivery.</li><li>
Collaborate and liaise with study team members, assigned sites, sponsors, vendors, and functional departments to support project execution, issue resolution, and timely completion of study deliverables.</li><li>
As applicable, support development of project subject recruitment plans on a per-site basis and provide input regarding recruitment risks, site performance trends, and mitigation strategies.</li><li>
As applicable, support site financial management according to executed clinical trial agreements, including tracking site payment status, reviewing site/investigator payment-related documentation, and retrieving invoices according to applicable requirements.</li><li>
Collaborate with Clinical Operations, Regulatory, Recruitment, Data Management, Pharmacy, Laboratory, Biometrics, Contracts, Finance, and other departments to support coordinated study execution.</li><li>
Communicate professionally with sponsors, monitors, vendors, auditors, and internal stakeholders regarding CRA activities, documentation expectations, findings, risks, and follow-up needs.</li><li>
Provide clear, timely, and solution-oriented communication regarding study status, monitoring outcomes, documentation gaps, and compliance concerns.</li><li>
Support sponsor visits, sponsor audits, regulatory inspections, bid defense preparation, project kickoffs, governance discussions, and study closeout activities as requested.</li></ul>
Senior-Level Leadership, Mentoring, and Process Improvement<ul><li>
Serve as a senior resource for CRA practices, Phase I documentation expectations, monitoring standards, GCP interpretation, and study execution quality.</li><li>
Mentor, train, and provide guidance to CRA staff, clinical research staff, and cross-functional team members on study documentation, monitoring expectations, and escalation practices.</li><li>
Identify opportunities to improve CRA processes, monitoring tools, templates, checklists, documentation quality, workflow efficiency, and inspection readiness.</li><li>
Assist with development, implementation, and refinement of CRA tools, training materials, SOP-related workflows, and best practices.</li><li>
Demonstrate professionalism, accountability, sound judgment, urgency, and leadership in interactions with staff, sponsors, vendors, participants, and external partners.</li><li>
May act as lead CRA or primary CRA contact for assigned studies, complex projects, sponsor engagements, or coverage needs.</li><li>
Other functions as directed and delegated.</li></ul>
The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
Skills/Qualifications
<ul><li>Ability to read, write, and interpret the English language.</li><li>
Strong working knowledge of clinical research operations, GCP, FDA regulations, ICH guidelines, informed consent requirements, and clinical trial documentation standards.</li><li>
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, Good Clinical Practice, and ICH guidelines.</li><li>
Good therapeutic area and protocol knowledge as provided through company, sponsor, and study-specific training.</li><li>
Demonstrated knowledge of CRA monitoring practices, source documentation review, essential document review, protocol deviation identification, issue escalation, and follow-up practices.</li><li>
Understanding of Phase I clinical pharmacology unit operations, including inpatient/outpatient study conduct, protocol-driven procedures, visit schedules, sample collection timing, safety assessments, and data integrity expectations.</li><li>
Excellent attention to detail and ability to produce accurate, complete, and timely documentation.</li><li>
Strong analytical, problem-solving, organizational, and time management skills.</li><li>
Ability to manage multiple competing priorities and meet deadlines in a fast-paced regulated environment.</li><li>
Professional written and verbal communication skills, including ability to interact effectively with sponsors, auditors, vendors, investigators, study staff, and cross-functional colleagues.</li><li>
Ability to identify risks, escalate concerns appropriately, and drive action items to resolution.</li><li>
Demonstrated professionalism, sound judgment, accountability, discretion, and commitment to quality.</li><li>
Ability to mentor, train, and guide less experienced staff.</li><li>
Proficient computer skills, including Microsoft Word, Excel, PowerPoint, Outlook, clinical trial systems, electronic data capture systems, eTMF/CTMS tools, and other applicable technologies</li></ul><div>
</div>Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
<ul><li>Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
</li><li>Ability to lift and/or move up to 25 pounds.
</li><li>Specific vision abilities required by this job include clarity of vision both near and far.
</li><li>Ability to identify and distinguish colors.</li></ul>
Hazards:<ul><li>
Potential for exposure to toxic or caustic chemicals</li><li>
Potential for exposure to blood borne pathogens</li></ul>
Education and Experience:
Required<ul><li>
Bachelor's degree in a scientific discipline, healthcare, nursing, clinical research, or a related field preferred; equivalent combination of education, training, and relevant clinical research experience may be accepted in lieu of degree.</li><li>
Minimum of 2 years of on-site monitoring experience required; additional progressive CRA, monitoring, clinical operations, or study oversight experience preferred for Senior CRA level.</li><li>
Experience supporting Phase I-III, clinical pharmacology, CRO, pharmaceutical, biotech, academic research, or clinical research unit studies.</li><li>
Strong knowledge of clinical trial conduct, applicable clinical research regulatory requirements, Good Clinical Practice, ICH guidelines, FDA regulations, source documentation, protocol compliance, and essential document requirements.</li><li>
Demonstrated experience identifying and escalating protocol deviations, documentation deficiencies, quality risks, and participant safety concerns.</li><li>
Ability to work independently, manage multiple priorities, and communicate effectively with sponsors and cross-functional teams.</li></ul>
Preferred<ul><li>
CCRA, CCRP, ACRP-CP, SOCRA, or other relevant clinical research certification.</li><li>
Prior Senior CRA, Lead CRA, monitoring, or audit-readiness experience in a Phase I clinical pharmacology unit or CRO environment.</li><li>
Experience with cardiac safety, thorough QT, first-in-human, SAD/MAD, bioequivalence, drug-drug interaction, food effect, renal/hepatic impairment, or other clinical pharmacology study designs.</li><li>
Experience with EDC, CTMS, eTMF, electronic source, clinical trial management tools, and sponsor portals.</li><li>
Experience mentoring CRA staff or training clinical research personnel.</li><li>
Experience supporting sponsor audits, regulatory inspections, CAPAs, root cause analysis, and process improvement initiatives.</li></ul>
Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.</div>

SENIOR CLINICAL RESEARCH ASSOCIATE

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader">Summary</h2></div><div>
The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with Baylor College of Medicine Department of Pediatrics at The Texas Children's Cancer and Hematology Centers (TXCH). This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This position requires expertise and understanding of clinical research and applicable regulations. 
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.</div></div><div><div><h2 class="jobSectionHeader">
Job Duties</h2></div><div><ul><li>
Coordinates regulatory correspondence across internal stakeholders and external institutions.</li><li>
Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH.</li><li>
Maintains and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.</li><li>
Maintains working knowledge of regulatory requirements through independent continuing education using guidelines, articles, and courses.</li><li>
Develops and maintains positive relationships with institutional review committees and sponsor through oral and written communications.</li><li>
Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.</li><li>
Facilitates investigators in reporting and responding to institutional review committees' and other regulatory agencies' inquiries or comments.</li><li>
Provides input to the investigators in consent form creation and protocol editing.</li><li>
Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.</li><li>
Prepares for FDA meetings, inspections, and audits from regulatory authorities. Is available on site during audit visit to reply to auditor inquiries.</li><li>
Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.</li><li>
Assures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects.</li><li>
Maintains regulatory database as applicable. Maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready.</li><li>
Keeps the study team and supervisor informed of protocol related issues.</li><li>
Participates in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other onsite meetings as required.</li><li>
Practices a high level of integrity and honesty in maintaining confidentiality.</li><li>
Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.</li><li>
Attends all required meetings and conferences, contributes pertinent protocol information and uses information presented to develop an understanding of the hematology/oncology landscape, in order to more accurately assist in the preparation of submissions.</li><li>
Plans and pursues activities to promote self development related to hematology/oncology and regulatory issues. Looks for opportunities to improve performance; manages time, work, and relationships effectively and efficiently.</li><li>
Performs other job related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Minimum Qualifications</h2></div><div><ul><li>
Bachelor's degree.</li><li>
Two years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Department Specific Criteria</h2></div><div><ul><li>
Two or more years of experience in regulatory affairs for clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.</li><li>
Demonstrated knowledge of regulatory processes and applicable regulations.</li><li>
Ability to manage regulatory aspects of multiple research projects.</li><li>
Ability to establish and maintain cooperative and mutually supportive working relationships with faculty, administrators, staff, other campus units, sponsors, their representatives, and other business partners.</li><li>
Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.</li><li>
Ability to serve as a resource to clinical investigators and staff.</li><li>
Ability to manage shifting priorities in short time frames.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Preferred Qualifications</h2></div><div><ul><li>
Certification in Clinical Research, SOCRA or other preferred.</li><li>
Should have excellent oral and written communication skills.</li><li>
Knowledge of medical/scientific terminology.</li><li>
Excellent organization skills; ability to multi-task.</li><li>
Strong computer skills including Microsoft Office Suite.</li><li>
High sense of professional behavior and conduct and an ability to communicate with various levels of faculty and staff within Baylor College of Medicine and outside organization.</li></ul></div></div></div> 
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment. 
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</div>

Regulatory Affairs Associate - Clinical Research

Foundation for Atlanta Veterans Education and Research, Inc.

Position Title: Clinical Research Coordinator 
Employment Status: Full-Time (40 hours/week) 
 
Position Summary 
The Clinical Research Coordinator will be responsible for, but not limited to, the following: - Identifying, recruiting and screening potential study participants, and conducting patient and family education accordingly. - Performing patient evaluations, administering medications and research instruments. - Making referrals to in-house or community professionals and serves as clinical resource. - Collecting and documenting data, assisting in developing data collection systems and compiling reports. - Collecting specimen, to include phlebotomy, processing and preparation for shipping, and vital signs. - Coordinating, implementing and evaluating clinical research trials, studies and projects to improve and advance clinical research within the organization. - Providing direction in the development of research protocols. - Providing leadership or assistance in identifying and writing study materials, brochures and correspondence. - Providing direction in auditing and monitoring activities. - Collaborating with multidisciplinary researchers to establish research programs that integrate new advances in clinical trials management. - Conducting on-going training of clinical trials staff, providing updated information on internal processes and resources and external benchmarks. - Ensuring compliance with research and health care regulatory requirements and guidelines. - Performing related responsibilities as required. 
 
Job Functions 
Function 1 (40%): Overall coordination and facilitation of clinical study activities. Collects, records, maintains all participant data and specimen, which may include phlebotomy, lab processing and shipping. 
Function 2 (40%): Managing patient / study participant recruitment, screening, follow-up visits, education and evaluations. 
Function 3 (20%): Report adverse event to governing agencies and sponsors as required by protocol and regulations. Responsible for administrative activities associated with the study, including interacting with regulatory organizations, sponsors and contract research organizations. 
 
Minimum Requirements 
Education: High school or GED is required. Bachelor's or Master's degree in science, public health, business is preferred.
 
 
Experience: 5+ years of research experience with a H.S. diploma or GED. 2+ years of research experience with a Bachelor's degree. 1+ year of research experience with Master&rsquo;s degree. Ideally, experience in performing research-related study activities is beneficial for a successful incumbent. These could include regulatory affairs, study procedures, phlebotomy certification, processing/shipping biological specimens (particularly stool samples), and data entry or database management. Cardiothoracic experience is strongly preferred. 
 
Specific Skills: High level of attention to detail and good organizational skills. Strong written and verbal communication skills. High level of use and comfort with MS Office products and other technological platforms. Friendly and people-oriented to ensure that the veteran population is engaged in a positive experience. Ability to achieve/exceed time-bound goals in both an independent and team environment. Capability to function independently after trial-specific training. Must possess and demonstrate a strong desire to recruit and work with study patients. 
 
Special Knowledge, Licenses, Etc.: Certified Research Associate (CRA) or Clinical Research Coordinator (CRC) preferred. 
 
Relocation and Visa sponsorship are not available for this position. 
 
We are committed to an inclusive and diverse workplace. All individuals, regardless of personal characteristics, are encouraged to apply! 
 
FAVER is an Equal Employment Opportunity Employer. FAVER provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.

Clinical Research Coordinator

Kaiser Permanente

<div><div>Job Summary:</div>
 
Collects data for clinical trials research, independently. Prepares and/or supports the submission of study documentation to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports). Assists with the development and/or implementation of standard and non-standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions, with limited guidance. Learns about providing input on implementing budgeting components for internally funded standard and non-standard projects. Drafts and/or prepares and submits clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures.<div> 

Essential Responsibilities:</div> 
 
<ul><li>Pursues effective relationships with others by proactively providing resources, information, advice, and expertise with coworkers and members. Listens to, seeks, and addresses performance feedback; provides mentoring to team members. Pursues self-development; creates plans and takes action to capitalize on strengths and develop weaknesses; influences others through technical explanations and examples. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; helps others adapt to new tasks and processes. Supports and responds to the needs of others to support a business outcome.</li> 
<li>
Completes work assignments autonomously by applying up-to-date expertise in subject area to generate creative solutions; ensures all procedures and policies are followed; leverages an understanding of data and resources to support projects or initiatives. Collaborates cross-functionally to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports, identifies, and monitors priorities, deadlines, and expectations. Identifies, speaks up, and implements ways to address improvement opportunities for team.</li> 
<li>
Works on budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard and nonstandard projects.</li> 
<li>
Conducts clinical research by: independently collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments); leveraging a comprehensive foundational knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; leveraging a comprehensive foundational knowledge of clinical trials, studies, and interventions at the site-level; independently contributing to the development of standard and nonstandard clinical research protocols and other processes of clinical trials; preparing and/or supporting the submission of study documentation to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for executing standard and non-standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard and non-standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens).</li> 
<li>
Ensures research compliance by: independently drafting and/or preparing and submitting clinical trial applications in compliance and consistency with all applicable federal, state, and local regulations, and reviewing and providing input on KP compliance policies and procedures; identifying compliance and/or quality issues and assisting in the development of corrective action plans, escalating as necessary; identifying opportunities to update compliance-monitoring/audit systems and documentation; utilizing standard approaches to analyze risk-management data and making recommendations to mitigate potential risk; independently implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; and leveraging comprehensive research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.</li> 
<li>
Maintains internal and external effective working relationships by: leveraging a comprehensive foundational knowledge of how to partner with research stakeholders and investigators within and across units to contribute to research projects; independently communicating with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions with limited guidance.</li> 
<li>
Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) in a timely and accurate manner; assisting with the development and/or implementation of standard and nonstandard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a comprehensive foundational knowledge of how to monitor and audit Clinical Trials as well as documenting findings.</li></ul><div> 
Knowledge, Skills and Abilities: (Core)</div><ul><li>
Ambiguity/Uncertainty Management</li><li>
Attention to Detail</li><li>
Business Knowledge</li><li>
Communication</li><li>
Critical Thinking</li><li>
Cross-Group Collaboration</li><li>
Decision Making</li><li>
Dependability</li><li>
Diversity, Equity, and Inclusion Support</li><li>
Drives Results</li><li>
Facilitation Skills</li><li>
Health Care Industry</li><li>
Influencing Others</li><li>
Integrity</li><li>
Learning Agility</li><li>
Organizational Savvy</li><li>
Problem Solving</li><li>
Short- and Long-term Learning &amp; Recall</li><li>
Teamwork</li><li>
Topic-Specific Communication</li></ul><div> 
Knowledge, Skills and Abilities: (Functional)</div><ul><li>
Accountability</li><li>
Adaptability</li><li>
Autonomy</li><li>
Business Relationship Management</li><li>
Clinical Research</li><li>
Clinical Research Quality</li><li>
Compliance</li><li>
Computer Literacy</li><li>
Data Quality</li><li>
Experimental Design</li><li>
Innovative Mindset</li><li>
Laboratory Equipment</li><li>
Laboratory Procedures</li><li>
Managing Diverse Relationships</li><li>
Organizational Skills</li><li>
Project Management</li><li>
Project Management Tools</li><li>
Quality Assurance Process</li><li>
Quantitative Research Methods</li><li>
Research Ethics</li><li>
Stakeholder Management</li><li>
Survey Methodology</li><li>
The Scientific Method</li></ul><div> 
Minimum Qualifications:</div> 
 
<ul><li>Bachelors degree in Science, Public Health, Health Care Administration, or related field AND minimum two (2) years of experience in clinical research or a directly related field OR Minimum five (5) years of experience in clinical research or a directly related field.</li></ul><div> 
Preferred Qualifications:</div><ul><li>
Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA).</li><li>
Basic Life Support (BLS) Certification.</li></ul> 
PrimaryLocation : California,Los Angeles,4733 Sunset Annex 
HoursPerWeek : 40 
Shift : Day 
Workdays : Mon, Tue, Wed, Thu, Fri 
WorkingHoursStart : 08:00 AM 
WorkingHoursEnd : 05:00 PM 
Job Schedule : Full-time 
Job Type : Standard 
Employee Status : Regular 
Employee Group/Union Affiliation : NUE-SCAL-01|NUE|Non Union Employee 
Job Level : Individual Contributor 
Job Category : Research 
Department : Department of Research and Evaluation 
Travel : Yes, 50 % of the Time 
Kaiser Permanente is an equal opportunity employer committed to fair, respectful, and inclusive workplaces. Applicants will be considered for employment without regard to race, religion, sex, age, national origin, disability, veteran status, or any other protected characteristic or status. 
 
For jobs where work will be performed in unincorporated LA County, the employer provides the following statement in accordance with the Los Angeles County Fair Chance Ordinance. Criminal history may have a direct, adverse, and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: 
 
<ul><li>Consistently supports compliance and the Principles of Responsibility (Kaiser Permanente's Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state, and local laws and regulations, accreditation, and licensure requirements (where applicable), and Kaiser Permanente's policies and procedures.</li></ul> 
<ul><li>Models and reinforces ethical behavior in self and others in accordance with the Principles of Responsibility, adheres to organizational policies and guidelines; supports compliance initiatives; maintains confidences; admits mistakes; conducts business with honesty, shows consistency in words and actions; follows through on commitments.</li></ul> 
<ul><li>Job duties with at least occasional or possible access to: (1) patients, the general public, or other employees; (2) confidential protected health information and other confidential KP information (including employee, proprietary, financial or trade secret information); (3) KP property and assets, for example, electronic assets, medical instruments, or devices; (4) controlled substances regulated by federal law or potentially subject to diversion.</li></ul></div>

Clinical Research Coordinator III, Cardiac Clinical Trials

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