clinical project coordinator

Cipaca Healthcare Services Private Limited

Job Description: We are looking for young and dynamic MBBS graduates with excellent communication and interpersonal skills to handle and coordinate clinical projects. This role offers an exciting opportunity to work in a fast-paced healthcare environment, ensuring smooth execution of clinical operations and coordination with various departments.Responsibilities:<ul><li>Coordinate and monitor ongoing clinical projects.</li><li>Communicate effectively with team.</li><li>Prepare reports, maintain documentation, and ensure compliance with protocols.</li><li>Participate in meetings and contribute to clinical planning and development activities.</li><li>Support quality and process improvement initiatives.</li></ul>Requirements:<ul><li>MBBS qualification (Freshers or up to 1 year of experience preferred).</li><li>Excellent communication and presentation skills.</li><li>Strong organizational and multitasking ability.</li><li>Willingness to learn and grow in a clinical management role.</li><li>Based in or willing to relocate to Chennai.</li><li>Ready to travel across India</li></ul>Salary &amp; Benefits:<ul><li>Starting salary: &#8377;40,000 per month (based on performance and experience).</li><li>Career growth opportunities in clinical management.</li><li>Supportive and collaborative work environment.</li></ul>How to Apply: Interested candidates can apply directly through Indeed or email their resume to hr@cipaca.com or contact: 636951905 with the subject line &ldquo;Application for MBBS &ndash; Clinical Project Coordinator&rdquo;.Job Type: Full-timePay: From &#8377;40,000.00 per monthWork Location: In person

MBBS Doctor – Clinical Project Coordinator (Freshers Welcome)

University of Miami

<div><h2 class="jobSectionHeader">Current Employees:
</h2>If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet .
The department of Psychiatry has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work onsite on the UHealth campus. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.
CORE JOB FUNCTIONS
<ul><li>Perform chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
</li><li>Coordinate routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
</li><li>Perform moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
</li><li>Understand and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
</li><li>Assist in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
</li><li>Address adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
</li><li>Identify, reports, and helps problem solve protocol deviations and unanticipated occurrences.
</li><li>Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
</li><li>Know the contents and maintenance of study-specific clinical research regulatory binders.
</li><li>Maintain requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
</li><li>Adhere to University and unit-level policies and procedures and safeguards University assets.
</li></ul>This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
<ul><li>Bachelor&rsquo;s degree in relevant field
</li><li>Minimum 1 year of relevant experience
</li></ul>Knowledge, Skills and Attitudes:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Commitment to the University&rsquo;s core values.
</li><li>Ability to work independently and/or in a collaborative environment.
</li></ul>The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A8</div>

Clinical Research Coordinator 1 (A)

Headlands Research

<div><div>At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.</div> 

<h1 class="jobSectionHeader">
Clinical Research Coordinator (CRC)</h1>

 Location: Maplewood, MN | Site Name: Headlands Research Twin Cities | Full-Time 


Are you an experienced clinical research professional with a passion for advancing medicine? Join a leading, integrated clinical research network dedicated to high-quality data, patient-centered care, and innovation in clinical trials.

We're seeking a Clinical Research Coordinator (CRC) for our clinical research site located in Maplewood, MN. The CRC will manage and execute Phase I-IV clinical studies in accordance with FDA regulations, GCP/ICH guidelines, and sponsor protocols. This role is ideal for someone who thrives in a fast-paced environment and is eager to make an impact in the clinical research industry.

Type: Regular Full-time Employee 
Schedule: Weekdays, Regular Business Hours 
Location: Onsite in Maplewood, MN (no capabilities for remote or hybrid work) 
Benefits: Our benefits package for full-time employees includes health insurance (medical, dental, and vision), Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), Paid Time Off (PTO), a variety of disability, accident, and life insurance options, as well as many more.
<h2 class="jobSectionHeader">
 What We Offer</h2>
<ul><li>Competitive pay (based on a combination of experience &amp; education background) + annual performance incentives</li>
<li>Medical, dental, and vision insurance</li>
<li>401(k) plan with company match</li>
<li>Paid time off (PTO) and company holidays</li>
<li>A mission-driven culture focused on advancing medicine and improving patient outcomes</li></ul> 


<h2 class="jobSectionHeader"> Why Join Us?</h2>

You'll be part of a growing, mission-driven organization that values its people. At our core, we're committed to bringing innovative medical treatments to patients faster&mdash;while creating an environment where employees thrive. If you're passionate about clinical research and ready to make a difference, we'd love to hear from you. 


Responsibilities: 

<ul>
<li>Coordinate all aspects of assigned clinical trials from site initiation to study close-out</li>
<li>Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards</li>
<li>Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs</li>
<li>Manage subject recruitment, informed consent, and retention strategies</li>
<li>Ensure timely data entry and resolution of EDC queries</li>
<li>Report and follow up on all adverse events, serious adverse events, and deviations</li>
<li>Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders</li>
<li>Prepare for and participate in monitoring visits, audits, and inspections</li>
<li>Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems</li>
<li>Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained)</li>
<li>Attend investigator meetings and provide cross-functional support as needed</li>
<li>Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control</li></ul> 


Requirements: 

<h2 class="jobSectionHeader">
 Education &amp; Experience Requirements</h2>
<ul><li>Required: High school diploma or GED</li>
<li>Experience:
<ul><li>Minimum of 2 years of experience in Clinical Research preferred</li>
<li>Nursing Degree (LPN or RN) preferred, but not required</li>
<li>Bachelor's degree in a health or scientific-related program preferred</li>
</ul> </li></ul><h2 class="jobSectionHeader">Skills &amp; Qualifications</h2>
<ul><li>Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures</li>
<li>Proficiency in medical terminology and clinical documentation practices</li>
<li>Strong interpersonal, verbal, and written communication skills</li>
<li>Organized, detail-oriented, and capable of managing multiple priorities</li>
<li>Proficient in Microsoft Office and other clinical research systems</li></ul> 


 Apply now to become a part of a team that's changing the future of healthcare&mdash;one trial at a time.</div>

Clinical Research Coordinator

<div><h2 class="jobSectionHeader">Current Employees:
</h2>If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet .
The University of Miami/UHealth Department of SCCC- CRS has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work at the UHealth campus in Miami, Fl.
CORE JOB SUMMARY
 
The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.
 
 
CORE JOB FUNCTIONS
 
1. Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
 
2. Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
 
3. Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
 
4. Maintains study binders and filings according to protocol requirements, UM and department policy.
 
5. Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
 
6. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
 
7. Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
 
8. Assists with study orientation and protocol related in-services to research team and clinical staff.
 
9. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
 
10. Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators&rsquo; academic administrative personnel, and departments.
 
11. Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
 
12. Adheres to cultural competency guidelines; implements strategies to meet study participants&rsquo; needs for language translation, health literacy, etc.
 
13. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
 
14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
 
15. Adheres to University and unit-level policies and procedures and safeguards University assets.
 
 
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
 
 
CORE QUALIFICATIONS
 
Education:
 
Bachelor&rsquo;s degree in relevant field required
 
 
Experience:
 
Minimum 2 years of relevant experience required
 
 
Knowledge, Skills and Abilities:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Commitment to the University&rsquo;s core values.
</li>Ability to work independently and/or in a collaborative environment. 
<li>
</li></ul> 
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A9</div>

Clinical Research Coordinator 2

MERIT CRO

<div>Description:

MERIT CRO, Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We&rsquo;re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities
The Project Coordinator will work under direct supervision, assists the Project Management Division with the coordination and conduct of project management activities, including the creation and distribution of study-related documents and the coordination of study activities. Carries out management directives in a professional, efficient, and thorough manner. Primary functions include supporting the management of clinical trial data in the EXCELSIOR&trade; cloud application environment; performing data upload, and quality control functions; maintenance of controlled documents including Master Project Files; and providing support functions for clinical sites, reading centers, and clients according to company and/or study-specific procedures and Good Clinical Practices (GCP).
ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)
Administrative Duties:<ul><li>
Assist in the management of office tasks, including organization and coordination of controlled documents</li><li>
Assist with all aspects of study management</li><li>
Assist in the development of the project and regulatory documents; includes proofreading of documents</li><li>
Assist in the creation, duplication, and dissemination of documents.</li><li>
Assist with responses to quality review audits</li><li>
Monitor own work to ensure quality and completeness</li></ul>
Study-Related Duties:<ul><li>
Assist with all study activities from start-up through close out</li><li>
Organize and prioritize work assignments to complete assignments and tasks on time, with quality, and has the ability to anticipate problem areas in advance.</li><li>
Apply creative approaches and ideas to solve problems maximizing the effective use of appropriate resources.</li><li>
Initiation of Master Project File and maintenance of project documents</li><li>
Generate and email eligibility notifications</li><li>
Attend project meetings internally and with the sponsor (via teleconference or face-to-face) throughout the project</li><li>
Communicate with Shipping and Receiving Department to confirm shipment and receipt of study-related materials at the designated address.</li></ul>
Software-related Duties:<ul><li>
Understand the EXCELSIOR&trade; product, protocol, and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members</li><li>
Assist with the review of EXCELSIOR&trade; study-specific configuration</li><li>
Manage and review site surveys; update EXCELSIOR&trade; for site registration</li><li>
Assist with providing guidance and training to sponsors, CROs, clinical sites, and graders on the use of EXCELSIOR&trade;, including software functionality and technical support</li><li>
Image check-in and quality control</li><li>
Issue and review data query responses to ensure completeness and accuracy of response relative to other data</li><li>
Review, categorize, and respond to customer support and complaint tickets in the helpdesk application</li><li>
Perform and document periodic review of inactive users in EXCELSIOR</li></ul>
Other:<ul><li>
Comply fully with company policies and Standard Operating Procedures (SOPs)</li><li>
Other responsibilities may be assigned as required</li></ul>
The following are the essential functions of the position but are not all-inclusive.
Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
Demonstrates a commitment to maintaining a safe, clean, and orderly work area. Promotes and follows safety regulations and actively contributes to work safely.
Requirements:

QUALIFICATION REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience:
Preferred Bachelor&rsquo;s degree in a health-related, biological science, computer science, data entry, customer service, or business management field (or internal company work experience).
Other Skills and Abilities:
Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess Company needs and work independently. Computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software. Must be able to project a professional attitude and image appropriate for the work environment.
Ability to participate and contribute in a team environment as a team member. Oral and written communication is clear, concise, and effective.
Licenses or Certifications Required:
None.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand, walk, and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel, and climb. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The noise level in the work environment is usually quiet to moderate 
Benefits Offered:
401(k)
Dental insurance
Disability insurance
Health insurance
Life insurance
Paid time off
Vision insurance
MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce. It is the employment policy and practice of MERIT CRO, Inc. to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.</div>

Project Coordinator I (Remote-US)

Vanderbilt University Medical Center

<div>Discover Vanderbilt University Medical Center : Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt&rsquo;s mission is to advance health and wellness through preeminent programs in patient care, education, and research.
Organization:
VICTR
Job Summary:
Research Projects Coordinator (Health Services Research Analyst) &ndash; VICTR
 
 
This is a full-time/exempt term position lasting six months to one year.
 
This role requires an approximate 25% travel commitment for attending in-person meetings.
 
 
JOB SUMMARY
 
As a Research Projects Coordinator, you will play a key role in providing support for research projects in health services research, public health, epidemiology, medicine, health policy or related disciplines with some guidance. Activities may include project coordination, literature searches, information collection, and report preparation. Provides general project support and coordinates dissemination of information.
 
 
About the Department:
 
The Vanderbilt Institute for Clinical &amp; Translational Research (VICTR) is Vanderbilt&rsquo;s virtual home for clinical and translational research. Supported by Vanderbilt University Medical Center&rsquo;s Office of Research and the NIH-sponsored Clinical and Translational Service Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. VICTR functions to help researchers and clinicians do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers. For more information, please visit https://victr.vumc.org/.
.
<div>KEY RESPONSIBILITIES
 
<ul><li>Supports research investigators and senior research staff.
</li><li>Supports collaboration between team members, both internal and external to the project.
</li><li>Prepares and executes portions of research projects in the areas of health and social science. Uses external resources to supplement, organize, and contribute to tasks.
</li><li>The responsibilities listed are a general overview of the position and additional duties may be assigned.
</li></ul> 
TECHNICAL CAPABILITIES
 
<ul><li>Presentation Skills (Novice): The ability to prepare effective presentations in content and function, able to speak competently to the level of the audience.
</li><li>Data Analysis (Novice): The ability to analyze data in an accurate manner.
</li><li>Study Design &amp; Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
</li><li>Research Administration (Fundamental Awareness): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.
</li><li>Data Management (Novice): Interpreting, analyzing and organizing reports and metrics.
</li></ul></div>Required Skills
<ul><li>Master's Degree Preferred
</li><li>2+ Years of Experience in a Research Environment Preferred
</li><li>Excellent written and oral communication skills
</li><li>Excellent organizational skills
</li><li>Excellent interpersonal skills
</li><li>Excellent critical thinking skills
</li><li>Detail oriented 
</li></ul>Additional Information:
This is a term position. A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends. This position may also have the opportunity to work remotely.
Core Accountabilities:
Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.
Core Capabilities :
Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.
Position Qualifications:
Responsibilities:
Certifications:
Work Experience:
Experience Level:
Education:
Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.</div>

Research Projects Coordinator

<div><h3 class="jobSectionHeader">We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology &ndash; it is all we do &ndash; combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking &ndash; we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.</h3><h4 class="jobSectionHeader">
Position Summary:</h4>
The Clinical Trial Associate coordinates activities on clinical research projects by working with the appropriate clinical teams (e.g. Project Management, Clinical Monitoring, Data Management, Medical Monitoring) on project related activities.<h4 class="jobSectionHeader">
Essential Functions:</h4><ul><li>
Draft project plans and create project documents for review prior to Sponsor review, as assigned.</li><li>
Act as a central contact and provides expert guidance to the clinical team for designated project communications, meeting coordination, meeting minutes, correspondence, and associated documentation.</li><li>
Coordinate activities on clinical trials, including active participation on weekly Sponsor and Investigator calls, maintaining project trackers, and communicating on behalf of the PM to the Sponsor, investigative sites, and vendors as appropriate.</li><li>
Schedule and maintain organization of all clinical project meetings.</li><li>
Accurately update and maintain clinical systems within the appropriate project timeline.</li><li>
Collect and submit documents for assigned Trial Master Files (TMF) per standard guidelines, to ensure continual TMF maintenance in an audit-ready state. Routinely perform TMF document Quality Checks (QCs).</li><li>
Prepare, handle, distribute, file, and archive clinical documentation and reports in a timely manner.</li><li>
Prepare and distribute agendas and minutes from Sponsor and Investigator for team meetings with review from the project management team for accuracy within established deadlines.</li><li>
Maintain accurate team contact lists for every assigned project, proactively gathering information, and updating the contact list. Ensure that the contact list is uploaded to the TMF, as required to meet Standard Operating Procedure timelines.</li><li>
Gather, track, and maintain project and site essential regulatory documents.</li><li>
Provide cross-functional project support to entire Clinical Project team.</li><li>
Prepare and compile trial related materials for investigative sites, including Investigator Site File (ISF) materials, site electronic binders, site instruction manuals, and trial templates, forms, and plans.</li><li>
Acts as Clinical Trial Associate back-up during absences as needed based on individual trial needs.</li><li>
Mentor and assist with training of Clinical Trial Associates.</li><li>
Assist with the development and implementation of clinical policies and procedures.</li><li>
Perform other related duties as assigned.</li></ul><h4 class="jobSectionHeader">
Job Requirements:</h4><ul><li>
Associate degree in a life science or health related field required with Bachelor&rsquo;s degree preferred (experience working in clinical research may be substituted for education at TD2&rsquo;s discretion)</li><li>
Minimum of 4 years of experience in an administrative role.</li><li>
At least 3 years of experience in support of clinical research with preference to oncology research.</li></ul><h4 class="jobSectionHeader">
Required Specialized/Technical Skills:</h4><ul><li>
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.</li><li>
Advanced written and verbal communication skills</li><li>
Knowledge of GCP, ICH guidelines and clinical trial regulations</li><li>
Ability to work collaboratively in a team environment.</li><li>
Experience managing Trial Master Files and/or Investigative Site Files.</li><li>
Ability to take initiative and work independently with minimal guidance.</li></ul>
Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran&rsquo;s status, gender, sexual orientation, gender identity, or gender expression.
#LI-Remote
#LI-TD2 
This is a remote position.</div>

Clinical Trial Associate

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