clinical research coordinator

Florida State University

<div><div><div><h2 class="jobSectionHeader"><b>Department</b></h2><div><br>
<div><div>
</div><p>The Clinical Research Hub within the Office of Research seeks to fill the clinical research coordinator position.<br>
https://clinical.research.fsu.edu/</p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Responsibilities</b></h2><div><br>
<div><div>
</div><p>This position collaborates with faculty, staff, students, and healthcare providers to develop and implement clinical research protocols. Provides regulatory support and provides guidance on electronic data capture systems . Consults with researchers on FDA, HIPAA, and Common Rule compliance and supports participant and site recruitment.</p><p>
Serves as a liaison for FSU Health Research Connections, helping researchers navigate institutional resources, tools, and services. Responds to research support requests and coordinates support across administrative units. Supports onboarding and engagement of investigators and study team members across departments, promoting interdisciplinary collaboration. Assists with tracking support requests and identifying gaps in service.</p><p>
When directly supporting individual research studies as a research coordinator: oversees, tracks, facilitates, and documents research procedures and progress, providing recommendations to research teams. Engages with FSU researchers and partner clinics to manage medical information and research data. Position may travel to study sites and study-related events to support implementation of study protocols, problem solve study-related issues, and attend research meetings and events.</p><p>
Supports the Clinical Research Hub initiatives by developing and coordinating trainings, outreach, and compliance activities. Assists with developing SOPs, maintaining documentation, growing the Hub&rsquo;s support services, and ensuring alignment with university-wide research standards and goals. Tracks study milestones, recruitment metrics, and service utilization to inform continuous improvement and reporting to leadership.</p><p>
In conjunction with the Clinical Research Program Manager and Clinical Research Hub Director, communicates with principal investigators (PIs) and study teams regarding ClinicalTrials.gov registration and reporting requirements. Reviews records in the Protocol Registration and Results System (PRS) to identify errors, missing, or outdated information. Notifies researchers of non-compliance and collaborates with institutional compliance leadership to enforce local, state, and federal policies related to clinical trial transparency and reporting.</p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Qualifications</b></h2><div><br>
<div><div>
</div><p>Bachelor&rsquo;s degree and two years of experience in a health-related field; or high school diploma/equivalent and six years of relevant experience.</p><ul><li>
Valid driver&rsquo;s license and access to reliable transportation for travel to study sites and related events.</li><li>
Demonstrated knowledge of federal, state, and local laws, ordinances, rules, and regulations related to clinical research (including HIPAA, Common Rule, FDA, and ClinicalTrials.gov).</li><li>
Strong customer service orientation, with the ability to communicate effectively and professionally with research participants, investigators, healthcare providers, and administrative staff.</li><li>
Excellent organizational, problem-solving, and critical thinking skills.</li><li>
Ability to interpret and apply research methodology, principles, and practices in health and clinical settings.</li><li>
Proficiency in conducting clinical and research projects, maintaining accurate records, and managing sensitive information with integrity and confidentiality.</li><li>
Ability to work collaboratively in a team environment and adapt to changing priorities.</li></ul>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Qualifications</b></h2><div><br>
<div><div>
</div><p>Our ideal candidate would have the experience, certifications, and/or characteristics listed below:</p><ul><li>
Certified Clinical Research Professional (CCRP), ACRP Certified Professional (ACRP-CP), or Certified Clinical Research Coordinator (CCRC).</li><li>
Experience with laboratory procedures, detail-oriented record-keeping, and data management systems (e.g., REDCap, Qualtrics).</li><li>
Experience in project management, regulatory submissions, and meeting time-sensitive deadlines.</li><li>
Experience working in clinical or academic research settings.</li><li>
Familiarity with Good Clinical Practice (GCP) guidelines and compliance processes.</li><li>
Demonstrated commitment to providing excellent service to diverse populations and fostering a welcoming, inclusive research environment.</li></ul>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>Contact Info</b></h2><div><br>
<div><div>
</div><p>Cassidy Cooksey at ccooksey@fsu.edu</p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
University Information</b></h2><div><br>
<div><div>
</div><p>One of the nation's elite research universities, Florida State University preserves, expands, and disseminates knowledge in the sciences, technology, arts, humanities, and professions, while embracing a philosophy of learning strongly rooted in the traditions of the liberal arts and critical thinking. Founded in 1851, Florida State University is the oldest continuous site of higher education in Florida. FSU is a community steeped in tradition that fosters research and encourages creativity. At FSU, there&rsquo;s the excitement of being part of a vibrant academic and professional community, surrounded by people whose ideas are shaping tomorrow&rsquo;s news!<br>
<br>
Learn more about our university and campuses.</p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
FSU Total Rewards</b></h2><div><br>
<div><div>
</div><p>FSU offers a robust Total Rewards package. Visit our website to learn more about our Compensation, Benefits, Wellness, Recognition, and Employee Development programs.<br>
<br>
Use our interactive tool to calculate Total Compensation options based on potential salary, benefits and retirement contributions, earned leave, and other employment-related perks.</p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
How To Apply</b></h2><div><br>
<div><div>
</div><p>If qualified and interested in a specific job opening as advertised, apply to Florida State University at https://jobs.fsu.edu. If you are a current FSU employee, apply via myFSU &gt; Self Service.<br>
<br>
Applicants are required to complete the online application with all applicable information. Applications must include all work history up to ten years, and education details even if attaching a resume.</p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Considerations</b></h2><div><br>
<div><div>
</div><p>This is an A&amp;P position.</p><p>
This position requires successful completion of a level 2 criminal history background check.</p>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Equal Employment Opportunity</b></h2><div><br>
<div><div>
</div><p>FSU is an Equal Employment Opportunity Employer.</p></div></div></div></div></div>

Clinical Research Coordinator

Cancer & Blood Clinic

<p><b>SUMMARY</b></p><p>The Cancer and Blood Specialty Clinic is seeking a dedicated Clinical Research Coordinator capable of traveling between Orange and LA County. The ideal candidate will play a crucial role in facilitating clinical research activities, ensuring compliance with protocols, and supporting the advancement of cancer and blood disorder treatments. This position offers a unique opportunity to contribute to cutting-edge research while providing essential support to our clinic's mission of improving patient outcomes.</p><p><b>ESSENTIAL DUTIES AND REPONSIBILITIES</b></p><ul><li><b>Study Coordination: </b>Coordinate and manage all aspects of clinical research studies, ensuring compliance with protocols, regulatory requirements, and ethical standards.</li><li><b>Participant Recruitment:</b> Recruit and screen potential study participants, explaining the study details, obtaining informed consent, and ensuring eligibility criteria are met.</li><li><b>Clinical Trial Monitoring:</b> Work with monitors and auditors to facilitate site visits, ensuring that the study is conducted in accordance with protocol, Good Clinical Practice (GCP), and applicable regulations.</li><li><b>Collaboration with Investigators: </b>Collaborate with principal investigators, physicians, and other healthcare professionals involved in the study. Communicate regularly to address issues and ensure the smooth progress of the research.</li><li><b>Adverse Event Reporting:</b> Monitor and report adverse events, ensuring timely and accurate reporting to regulatory authorities, sponsors, and other relevant stakeholders.</li><li><b>Documentation and Record Keeping:</b> Maintain accurate and organized study documentation, including case report forms, source documents, and other study-related records.</li><li><b>Quality Assurance:</b> Implement quality assurance processes to ensure the integrity of study data and compliance with regulatory standards.</li><li><b>Communication Skills:</b> Effectively communicate with study participants, investigators, sponsors, and other stakeholders. Provide regular updates on study progress and address inquiries.</li><li><b>Problem-Solving: </b>Identify and resolve issues or challenges that may arise during the course of the study, working proactively to prevent potential problems.</li></ul><p><b>QUALIFICATIONS</b></p><ul><li>Bachelor's or advanced degree in a relevant field is preferred but not required.</li><li>Experience in clinical research, and knowledge of regulatory requirements. Strong organizational, communication, and interpersonal skills are essential for success in this role and strongly encouraged.</li><li>Traveling to different locations between our Orange County and LA County clinics is required for this position.</li></ul><p>Job Type: Full-time</p><p>Pay: $26.00 - $43.00 per hour</p><p>Benefits:</p><ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul><p>Experience:</p><ul><li>oncology/hematology: 1 year (Preferred)</li><li>clinical trial: 1 year (Preferred)</li></ul><p>Location:</p><ul><li>Torrance, CA 90505 (Preferred)</li></ul><p>Work Location: In person</p>

Carbon Health

<div><p>As a physician-founded and led organization, ensuring everyone has access to quality healthcare is what inspires us. The magic we&rsquo;ve created lies in Carbon Health&rsquo;s custom EHR and the collaboration among clinical teams, engineers, and designers who work side-by-side to deliver innovation like our hands free AI charting tool. That&rsquo;s why we hire people who genuinely care about patients, solving healthcare challenges, and making a positive impact every day. Join us and help change the future of healthcare for the better.</p><p></p><p>
We&rsquo;re looking for a Research Coordinator <b>based in California </b>to provide research support for clinical studies run by Carbon Health&rsquo;s clinical research program, Carbon for Research. If you are passionate about clinical research and want to be part of building our clinical research division and part of a rapidly growing company, then this is the role for you.In this role, you&rsquo;ll partake in clinical research studies from initiation to completion. You will coordinate day to day operations of projects.You&rsquo;ll work closely with Principal Investigators, co-investigators, our clinical research supervisor, clinical research coordinators, clinics and its staff for each study that you are supporting, along with the Launchpad (HQ) team. There will be peak periods during the year with high workloads due to overlapping deadlines and time sensitive priorities.</p><p></p><p><b><i>
(This role is </i></b><b><i>NOT remote</i></b><b><i>; it may include travel occasionally, within California or out of state.)</i></b></p><p></p><p><b>
WHAT YOU&rsquo;LL DO</b></p><ul><li><p>
Lead the coordination of clinical research studies from start-up to close-out, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.</p></li><li><p>
Provide guidance to team members involved in study coordination activities. Delegate tasks, monitor progress, and ensure effective teamwork and collaboration.</p></li><li><p>
Ensure compliance with regulatory requirements, policies, and study protocols.</p></li><li><p>
Prepare and submit regulatory documents, including Institutional Review Board (IRB) submission.</p></li><li><p>
Collect, complete, and maintain essential clinical trial documents including, but not limited to study member CVs, clinical licenses, financial disclosures, FDA-required documents, protocol training and responsibility logs.</p></li><li><p>
Conduct patient screening and visits on-site or guide clinic staff remotely, organize and schedule initial and ongoing patient follow-up, including arranging lab work and appointments as needed per protocol.</p></li><li><p>
Prepare administrative forms, documents, and case report forms as requested and perform data entry in electronic data capture systems and answer administrative queries that arise in a timely manner.</p></li><li><p>
Maintain discretion and confidentiality of sensitive records and information.</p></li></ul><p><b>
ABOUT YOU</b></p><ul><li><p>
Undergraduate degree required (health-related field is a plus)</p></li><li><p>
Minimum of 2 years related experience with clinical research</p></li><li><p>
Ability to work within a team environment</p></li><li><p>
Knowledge of research ethics and regulations</p></li><li><p>
Excellent communications skills (verbal and written) and interpersonal skills are required</p></li></ul><p><b>
PERKS</b></p><ul><li><p>
Forward-thinking, transparent, and inclusive company culture</p></li><li><p>
Collaborative environment within and across our clinic sites and at HQ in Sunnyvale, CA.</p></li></ul><p></p><p><b>
Hourly Rate Range:</b> $30.00 - $40.00/hour (based on skills and experience)</p><h2 class="jobSectionHeader"><b>
BENEFITS</b></h2><ul><li><p>
Medical, dental &amp; vision coverage, effective first day of employment</p></li><li><p>
Health Savings Account &amp; Flexible Savings Account option for health care &amp; dependent care</p></li><li><p>
Paid time off, paid sick leave</p></li><li><p>
401k retirement savings plans with employer match</p></li><li><p>
Life &amp; Disability Insurance</p></li><li><p>
DOT certification will be reimbursed where it is required for practice</p></li></ul><p></p><ul><li><i>Some benefits dependent on specialty and employment status</i></li></ul><p></p><p>
We recognize that the key to success lies in valuing the minds, experiences and perspectives of people from all walks of life. Carbon Health is proud to value diversity and be an equal opportunity employer. Pursuant to the San Francisco Fair Chance Ordinance and the Los Angeles Fair Chance Initiative for Hiring, we will consider for employment qualified applicants with arrest and conviction records. Carbon Health is an E-Verify employer.</p></div>

University of Wisconsin–Madison

<div><p><i>Current employees: if you are currently employed at any of the universities of wisconsin, log in to workday to apply through the internal application process.</i></p><p></p><p>
Job category:</p>
Academic Staff<p></p><p>
Employment type:</p>
Regular<p></p><p>
Job profile:</p>
Clin Res Coord II<p></p><p>
Job summary:</p><p>
The Department of Medicine, Division of General Internal Medicine offers a unique opportunity for a Clinical Research Coordinator to support. The Department of Medicine offers a unique opportunity for a Clinical Research Specialist to support Drs. Joan Neuner and David Feldstein in General Internal Medicine &ndash; Health Services. This group of three to four faculty physicians, a PhD research scientist and other team members works on research across multiple topics in primary care. Our unit has a particular focus on developing ways to improve delivery of health care. A new employee who would bring skills in connecting with patients and providers would add greatly to our ability to examine the implementation and impact of these health care delivery innovations. Projects include multi-site randomized trials, as well as, observational and pilot studies.
</p><p></p><ul><li><p>This position is full or part-time, 80%-100%.</p></li>
<li><p>
The work schedule is flexible and will be determined at the time of hire.</p></li>
<li><p>
This position may require some work to be performed in person, onsite, at a designated campus work location. Some work may be performed, remotely, at an offsite, non-campus work location.</p></li>
<li><p>
This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.</p></li>
<li><p>
Candidates who demonstrate the following knowledge, skills, and abilities, will be given first consideration: 1. Excellent interpersonal, written, and oral communication, 2. Experience with quantitative and qualitative methods, 3. Strong problem solving and orgnizational skills with attention to detail, 4. Ability to complete multiple tasks and to prioritize on deadline</p></li>
</ul><p></p><p>
Key job responsibilities:</p><ul><li>
Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training. Contributes to the development of protocols</li></ul><ul><li>
Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional. Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy</li></ul><ul><li>
May assist with training of staff</li></ul><ul><li>
Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols</li></ul><ul><li>
Identifies work unit resources needs and manages supply and equipment inventory levels</li></ul><ul><li>
Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues</li></ul><ul><li>
Performs quality checks</li></ul><ul><li>
Schedules logistics, determines workflows, and secures resources for clinical research trials</li></ul><p></p><p>
Department:</p><p>
School of Medicine and Public Health, Department of Medicine, Division of General Internal Medicine</p><p></p><p>
Fueled by innovation yet grounded in kindness, the Department of Medicine empowers leaders to transform medicine and improve lives everywhere. We are committed to professional fulfillment and health equity. We strive to ensure that everyone in our department understands the importance of social impact and belonging&mdash;and is empowered to champion it in all they do. Join us and be a part of supporting our nationally recognized faculty, innovative medical education programs and exceptional clinical care as we work towards our vision of healthy people and healthy communities!</p><p></p><p>
At the Division of General Internal Medicine, we design and deliver state-of-the-art primary care that helps all people live their healthiest lives. We are experts in ambulatory education, population health and chronic medical care for complex patients&mdash;and we work in partnership with our world-class university and remarkable health system. We are innovative, collaborative, and compassionate. We strive for excellence and equity.</p><p></p><p>
Compensation:</p><p>
The starting salary for the position is $50,000; but is negotiable based on experience and qualifications.</p><p></p><p>
Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits.</p><p></p><p>
Effective July 1, 2024, the U.S. Department of Labor Fair Labor Standards Act (FLSA) requires that positions earning less than $43,888 annually be considered non-exempt under FLSA provisions for overtime. Based on these rules, if the person selected for this recruitment will earn less than the new salary threshold at July 1, 2024 ($43,888 annually), they will be an academic staff non-exempt employee, will be paid hourly and will receive overtime compensation for any hours worked over 40 in a workweek.</p><p></p><p>
Required Qualifications:</p><ul><li><p>
Experience at least 1 years in biomedical or health research setting</p></li></ul><p></p><p>
Preferred qualifications:</p><ul>
<li><p>
Experience 3 years in biomedical or health research setting</p></li>
<li><p>
Experience with data management and presentation with software such as excel</p></li>
<li><p>
Experience with interviews and clinical observations</p></li>
<li><p>
Patient or customer service experience</p></li>
</ul><p></p><p>
Education:</p><p>
Bachelor&rsquo;s Degree Preferred; focus in Social or Biological Science, Healthcare or related field Preferred</p><p></p><p>
How to apply:</p><p>
To apply for this position, please click on the &quot;I am a current employee&quot; button or &quot;I am not a current employee&quot; button under Apply Now. You will be prompted to upload the following documents.</p><ul>
<li><p>
Cover Letter</p></li>
<li><p>
Resume</p></li>
</ul><p>
Please note, there is only one attachment field. You must upload all of your documents in the attachment field.</p><p></p><p>
Applicants are to submit a cover letter and resume detailing their training and experience relating to the required and preferred qualifications referenced above. The application reviewers will be relying on written application materials to determine which qualified applicants will advance in the recruitment process. We will notify selected applicants to participate further in the selection process directly. References will be requested of final candidates. All applicants will be notified after the search is complete and a candidate has been selected.</p><p></p><p>
University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work.</p><p></p><p>
The department will not be able to support a request for a J-1 waiver. If you choose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees.</p><p></p><p>
Contact information:</p><p>
Kassie Hefty, kjhefty@medicine.wisc.edu</p><p>
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.</p><p></p><p>
Institutional statement on diversity:</p><p>
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.<br>
<br>
The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.</p><p></p><p><br>
The University of Wisconsin-Madison is an Equal Opportunity Employer.</p><p>
Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply.</p><p></p><p>
To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you.</p><p></p><p>
Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment.<br>
<br>
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).<br>
<br>
The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.</p></div>

US Foot and Ankle Specialists

<p></p><div><div><div><p><b>Position Overview:</b></p>
</div>
<div><p>The CRC is responsible for managing and conducting clinical research projects by leading overall trial operations, collecting data, informing study participants about study objectives, administering questionnaires, ensuring Foot and Ankle Specialists of the Mid-Atlantic (FASMA) Standard Operating Procedures (SOPs) are followed and working closely with the sponsor/Clinical Research Organization (CRO).</p></div><div><br>
<p>
</p></div><div><p><b>Required Education, </b><b>Skills</b><b> and </b><b>Experience:</b></p>
</div>
<ul><li>Preferable to have an Associate&rsquo;s degree in business administration, biology, health sciences, healthcare or any related field, or comparable clinical research industry experience.</li>
<li>Preferable to have a minimum of 2 years of Site Coordinating experience. Must have exceptional technical and communication skills. Candidate needs the ability to be proactive, multitask and maintain excellent organizational skills.</li>
<li>Excellent attention to detail</li>
<li>Knowledge of biological and medical terminology</li>
<li>Understanding of the principles of administration and management</li>
<li>Superior organizational and time management</li>
<li>Capable of working independently and also as part of a team</li>
<li>Excellent verbal and written communication skills</li>
<li>Superior multi-tasking skills</li></ul></div><br>
<div>
<p></p><div><p><b>Essential Functions/Responsibilities (other duties may be assigned):</b></p>
</div>
<ul><li>Monitors study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory, institutional policies, and FASMA SOPs.</li>
<li>Has an in-depth knowledge of protocol requirements.</li>
<li>Acts as liaison between the investigators, medical providers, the Institutional Review Board (IRB), CRO and sponsor.</li>
<li>Maintains required records of study activity including Case Report Forms (CRFs), source, narrative notes, drug dispensing records, and all regulatory forms.</li>
<li>Tracks enrollment status of subjects and documents withdrawal information such as withdrawal causes and subject contact efforts.</li>
<li>Inputs and uploads subject information and pertinent clinical data to study specific study databases and/or EDC (Electronic Data Capture) sites and FASMA Clinical Trial Management System (CTMS) within appropriate timeframe defined by the protocol, sponsor, and SOPs.</li>
<li>Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians, nurses, medical assistants, and other staff. Enters potential subject demographics into FASMA CTMS.</li>
<li>Oversees subject enrollment to ensure that informed consent is properly obtained and documented.</li>
<li>Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.</li>
<li>Records and reports serious adverse events to the sponsor or other regulatory authorities within the appropriate reporting guidelines and timeframe.</li>
<li>Prepares, participates, and documents quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.</li>
<li>Identifies protocol problems, informs investigators of problems, and assists in problem resolution efforts such as protocol revisions.</li>
<li>Manages the inventory of equipment and supplies related to each study. This includes ordering of Investigational Product (IP), temperature recording devices, calibrations, and all necessary supplies for study completion.</li>
<li>Prepares study-related documentation such as protocol worksheets, source, procedural manuals, adverse event reports, institutional review board documents, and progress reports.</li>
<li>Maintains complete regulatory files and Investigator Site File (ISF). This includes completing all appropriate subject logs, screening and enrollment logs, study product/IP accountability logs, training documents, filing all applicable documents, correspondence etc.</li>
<li>Completes and submits IRB initial, renewal and closure applications.</li>
<li>Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, and documentation procedures.</li>
<li>Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. Communicates with laboratories or investigators regarding laboratory findings.</li>
<li>May assist with contracting with local vendors such as local laboratory.</li>
<li>Reviews scientific literature and participates in relevant education activities to maintain knowledge of clinical studies affairs and issues.</li>
<li>Maintains Good Clinical Practice (GCP) certification and all other project specific certifications.</li>
<li>Maintains accurate and legible records, following ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) principles</li>
<li>Manages site specific research staff CV&rsquo;s, licenses and applicable trainings (i.e. GCP, IATA, etc.)</li>
<li>Ensures site has all appropriate credentials and certifications (i.e. IATA, CLIA, etc.). If applicable, with approval, assist with renewal or apply for appropriate credentials and certifications.</li>
<li>Acts as a contact liaison for study participants by answering questions and keeping them informed of study protocol.</li>
<li>Communicates with manager with all pertinent study related progress, issues and when subjects have completed the trial.</li>
<li>Arranges for secure retention of all study documents in accordance with sponsor requirements and site SOP, whichever is longer.</li>
<li>Manage all locked areas where investigational or study products and supplies are stored.</li>
<li>Tracks and maintains temperature and maintenance logs and/or devices for research related equipment.</li>
<li>Draws blood or supervises the on-site drawing of blood as dictated by the research protocol. For delegated blood draws, document fully on the Delegation of Authority log. Coordinates local lab draws as needed. For post markets studies, this will usually only involve a finger stick. Acquires other lab requirements as necessary per protocol.</li>
<li>Manages the day-to-day activities of each study including trial operations, problem solving, communication, inventory control, and protocol management.</li>
<li>Maintain strict confidentiality and blinding protocol, if applicable, at all times.</li>
<li>Responds to study queries within appropriate timeframe defined by the protocol, sponsor, and SOPs.</li></ul></div><br>
<div>
</div><p></p><div><p><b>Physical Requirements:</b></p>
<p>
The physical demands described here represent those required to perform essential job functions. Reasonable accommodation may be made for individuals with disabilities. While performing this role, the employee must regularly:</p>
<ul>
<li><p>Sit, talk, hear, and use hands to write, type, or operate office equipment</p>
</li>
<li><p>Occasionally reach with hands and arms; climb, balance, stoop, kneel, crouch, crawl, and smell</p>
</li>
<li><p>Perform repetitive motions, including reaching overhead and typing</p>
</li>
<li><p>Lift up to 50 pounds occasionally and carry objects weighing up to 25 pounds</p>
</li>
<li><p>Maintain peripheral vision, depth perception, and focus adjustments</p></li></ul><br>
<p><b>
</b></p><p><b>Benefits Offered:</b></p>
<ul>
<li><p>Health Insurance (Single &amp; Family plans available)</p>
</li>
<li><p>Life Insurance</p>
</li>
<li><p>Disability Insurance</p>
</li>
<li><p>401(k) plan with Company Match</p>
</li>
<li><p>Employee Discount Program</p>
</li>
<li><p>Paid Time Off</p>
</li>
<li><p>Paid Holidays</p></li></ul></div><div></div><div><br>
<p>
</p></div><p></p><h4 class="jobSectionHeader"><b>Experience</b></h4>
Preferred<ul><li>
2 year(s): Prior podiatry or orthopedic clinical experience a plus</li></ul><h4 class="jobSectionHeader"><b>
Behaviors</b></h4>
Required<ul><li>
Dedicated: Devoted to a task or purpose with loyalty or integrity</li><li>
Team Player: Works well as a member of a group</li><li>
Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well</li></ul><h4 class="jobSectionHeader"><b>
Motivations</b></h4>
Required<ul><li>
Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization</li><li>
Goal Completion: Inspired to perform well by the completion of tasks</li><li>
Self-Starter: Inspired to perform without outside help</li></ul><p>
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities<br>
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</p></div>

Northwell Health

<p></p><div><div><p>Job Description</p>
<p>
Coordinates and monitors research trials; actively oversees the recruitment of study participants. May be required to perform venipuncture on study participants; collects, processes, and ships specimens according to protocol and training requirements. Adheres to good clinical practice, and complies with regulatory and grant agency requirements, and study protocol; maintains study records and collaborates with the institutional review board as necessary.</p>
<p>
Job Responsibility</p>
<p>
</p><ul><li>Responsible for coordination of a designated study or group of studies.
</li><li>In research projects, oversees recruitment of subjects, implementation of study procedures, and the collection and processing of data.
</li><li>Keeps accurate and up-to-date records.
</li><li>Collects labels, logs, processes, and ships biological specimens for analysis according to protocol and training requirements.
</li><li>Schedules subjects for protocol-related evaluations; collaborates with physicians, investigators and other healthcare providers; promotes respect for subjects&rsquo; rights.
</li><li>Administers, scores and evaluates results of assessments as assigned and as related to study protocol; collects data, confers with PI and forwards results to sponsor (internal or external).
</li><li>Interfaces with external agencies as necessary; organizes all phases of grant process for submission to funding agencies as necessary.
</li><li>Ensures availability of drug supplies and/or equipment for studies; maintains drug accountability logs.
</li><li>Liaisons with agencies and pharmaceutical companies, laboratories, and equipment and supply companies, as needed.
</li><li>Adheres to good clinical practice, and complies with regulatory and grant agency requirements; follows protocol as developed and keeps investigator or supervisor informed of developments.
</li><li>Collaborates with PI and the food and drug administration and drug companies on related issues; may be required to perform phlebotomy, electrocardiograms, or monitor vital signs on study participants and report findings to supervisor.
</li><li>Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action.
</li><li>Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.</li>
</ul>
<p>Job Qualification</p>
<p>
</p><ul><li>Bachelor's Degree required, or equivalent combination of education and related experience.</li>
<li>1-3 years of relevant experience, required.</li>
<li>2-3 years of clinical research experience.</li></ul><br>
<div><br>
<ul><li><b>Additional Salary Detail</b>
</li></ul>The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).</div></div></div>

<p></p><div><div><p>Job Description</p>
<p>
Coordinates and monitors research trials; actively oversees the recruitment of study participants. May be required to perform venipuncture on study participants; collects, processes, and ships specimens according to protocol and training requirements. Adheres to good clinical practice, and complies with regulatory and grant agency requirements, and study protocol; maintains study records and collaborates with the institutional review board as necessary.</p>
<p>
Job Responsibility</p>
<p>
</p><ul><li>Responsible for coordination of a designated study or group of studies.
</li><li>In research projects, oversees recruitment of subjects, implementation of study procedures, and the collection and processing of data.
</li><li>Keeps accurate and up-to-date records.
</li><li>Collects labels, logs, processes, and ships biological specimens for analysis according to protocol and training requirements.
</li><li>Schedules subjects for protocol-related evaluations; collaborates with physicians, investigators and other healthcare providers; promotes respect for subjects&rsquo; rights.
</li><li>Administers, scores and evaluates results of assessments as assigned and as related to study protocol; collects data, confers with PI and forwards results to sponsor (internal or external).
</li><li>Interfaces with external agencies as necessary; organizes all phases of grant process for submission to funding agencies as necessary.
</li><li>Ensures availability of drug supplies and/or equipment for studies; maintains drug accountability logs.
</li><li>Liaisons with agencies and pharmaceutical companies, laboratories, and equipment and supply companies, as needed.
</li><li>Adheres to good clinical practice, and complies with regulatory and grant agency requirements; follows protocol as developed and keeps investigator or supervisor informed of developments.
</li><li>Collaborates with PI and the food and drug administration and drug companies on related issues; may be required to perform phlebotomy, electrocardiograms, or monitor vital signs on study participants and report findings to supervisor.
</li><li>Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action.
</li><li>Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.</li>
</ul>
<p>Job Qualification</p>
<p>
</p><ul><li>Bachelor's Degree required, or equivalent combination of education and related experience.</li>
<li>1-3 years of relevant experience, required.</li>
<li>2-3 years of research experience.</li></ul><br>
<div><br>
<ul><li><b>Additional Salary Detail</b>
</li></ul>The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).</div></div></div>

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