CLINICAL RESEARCH COORDINATOR / CLINICAL RESEARCH ASSOCIATE (SITE-BASED)
Cottonwood Endocrinology and Diabetes Care
Sandy, Utah | Full-Time | On-Site
Two Positions Available
Compensation: $26–$32/hour, depending on experience
POSITION OVERVIEW
Cottonwood Endocrinology and Diabetes Care is seeking two experienced Clinical Research Coordinators / Clinical Research Associates to join our growing clinical research program in Sandy, Utah.
These are 100% hands-on, site-based clinical research positions working directly with research participants, the Principal Investigator, and our Clinical Research Manager.
We conduct primarily industry-sponsored Phase III pharmaceutical and medical-device trials, along with selected Phase II studies, focused primarily on diabetes, obesity, metabolic disease, incretin-based therapies, and diabetes technology.
Our program currently has approximately five active clinical trials and is expanding toward approximately 10–12 concurrent studies.
Prior hands-on experience working on sponsor- or CRO-managed Phase II or Phase III pharmaceutical or medical-device clinical trials is required.
We are NOT seeking candidates whose research experience is limited to academic, laboratory, observational, or non-industry research.
REPORTING STRUCTURE
The Clinical Research Coordinator/Associate reports directly to the Clinical Research Manager and works closely with the Principal Investigator.
The Clinical Research Manager remains actively involved in study execution and works alongside the research team.
Successful candidates must be comfortable:
- Working independently on assigned study responsibilities
- Functioning collaboratively as part of a research team
- Taking direction and supervision from the Clinical Research Manager
- Working directly with the Principal Investigator
- Communicating professionally with sponsors, CROs, monitors, laboratories, and study vendors
- Following protocol requirements precisely
KEY RESPONSIBILITIES
CLINICAL TRIAL & PARTICIPANT ACTIVITIES
- Conduct protocol-required study visits for Phase II and Phase III clinical trials
- Identify and prescreen potential study participants
- Assist with screening, informed consent, enrollment, and randomization
- Review inclusion and exclusion criteria with the research team and Principal Investigator
- Perform protocol-specific study procedures
- Obtain vital signs, measurements, ECGs, questionnaires, and other required clinical data
- Coordinate study medications and devices according to protocol
- Maintain accurate source documentation
- Track study visits, protocol windows, and required follow-up
- Communicate with research participants regarding visits and study requirements
- Maintain excellent participant retention and follow-up
- Recognize and appropriately escalate adverse events, protocol deviations, and other safety or compliance concerns
DATA ENTRY & SPONSOR SYSTEMS
Candidates must already be comfortable working with multiple sponsor and CRO electronic data capture (EDC) systems.
Responsibilities include:
- Enter clinical trial data accurately and promptly into electronic data capture (EDC) systems
- Work with multiple sponsor, CRO, laboratory, imaging, device, and study-specific portals
- Manage study queries and data corrections
- Maintain source documentation consistent with entered study data
- Track outstanding sponsor requests and action items
- Use electronic randomization and investigational product systems when required
- Maintain study logs and electronic study documentation
- Respond appropriately and promptly to monitor and sponsor requests
Candidates should be comfortable learning new sponsor platforms without extensive retraining.
PHLEBOTOMY & LABORATORY PROCEDURES
Strong phlebotomy skills are a major plus for this position. Candidates without prior phlebotomy experience must be willing to complete formal phlebotomy training (with training costs reimbursed by the practice).
Depending on experience and study assignment, responsibilities may include:
- Venipuncture
- Protocol-specific blood collection
- Timed and serial blood draws
- Processing and centrifuging research specimens
- Aliquoting and labeling specimens
- Freezing or preparing specimens according to protocol
- Packaging and shipping specimens to central laboratories
- Completing laboratory requisitions and specimen documentation
- Current IATA/DOT biological specimen and dangerous-goods shipping training is preferred; candidates must be willing to complete required certification/training at the practice’s expense.
Experience with Phase II pharmacokinetic/pharmacodynamic studies and timed specimen collection is a plus.
SPONSOR & MONITOR INTERACTIONS
- Work professionally with sponsor and CRO Clinical Research Associates/monitors
- Prepare assigned study materials for monitoring visits
- Respond to monitoring findings and data queries
- Participate in site initiation, interim monitoring, and closeout visits
- Provide requested study documentation
- Communicate study issues promptly to the Clinical Research Manager and Principal Investigator
- Help maintain the site in a continuous state of monitoring and audit readiness
REGULATORY & STUDY DOCUMENTATION
Working under the Clinical Research Manager, the Coordinator/Associate will assist with:
- Regulatory documentation
- Central IRB documentation
- Delegation and training logs
- Protocol amendments
- Investigator Site File/regulatory binder maintenance
- Study-specific training documentation
- Protocol deviation documentation
- Adverse-event documentation
- Sponsor-required study logs and essential documents
The Clinical Research Manager is responsible for research operations and regulatory coordination; this position is expected to reliably complete assigned responsibilities within that structure.
QUALIFICATIONS
Required
- Prior hands-on experience coordinating or conducting industry-sponsored Phase II or Phase III pharmaceutical or medical-device clinical trials
- Practical understanding of the day-to-day requirements of industry clinical trial execution
- Prior experience entering data into EDC and multiple sponsor/CRO study portals
- Experience maintaining accurate source documentation
- Familiarity with sponsor monitoring visits and data queries
- Working knowledge of ICH-GCP and clinical research requirements
- Ability to follow detailed study protocols accurately
- Strong organizational and time-management skills
- Strong computer skills and ability to learn new sponsor systems
- Excellent written and verbal communication skills
- Ability to manage multiple studies and competing deadlines
- Ability to work effectively under the supervision of the Clinical Research Manager and Principal Investigator
- Professional and compassionate communication with research participants
- High level of attention to detail and follow-through
Candidates without prior hands-on industry-sponsored clinical trial experience will not be considered for these positions.
Strongly Preferred
- Experience with diabetes, obesity, endocrinology, metabolic disease, or related clinical trials
- Experience with pharmaceutical trials
- Experience with medical-device trials
- Experience with GLP-1 receptor agonists, incretin therapies, or diabetes technology
- Strong phlebotomy skills
- Research specimen processing and shipping experience
- Experience with Phase II studies
- Experience with PK/PD studies and timed or serial blood collections
- Experience managing multiple active protocols simultaneously
- ACRP or SOCRA certification
- IATA/DOT biological specimen and dangerous-goods shipping training is preferred; candidates must be willing to complete required certification/training if not certified
WHO WE ARE LOOKING FOR
We are looking for experienced clinical research professionals who already understand the nuts and bolts of conducting industry-sponsored clinical trials at the site level.
A successful candidate should be able to come into an active study, learn the specific protocol and sponsor systems, and quickly become a productive member of the research team without needing to be taught the fundamentals of clinical research.
You should be:
- Highly organized
- Detail-oriented
- Dependable
- Honest and prompt to identify errors and protocol deviations
- Comfortable working directly with patients
- Comfortable with computers and multiple electronic systems
- Able to follow complex protocols precisely
- Responsive to sponsor and monitor requests
- Able to accept direction and feedback
- Comfortable working both independently and as part of a team
- Willing to take ownership of assigned responsibilities
- Able to manage several studies and priorities simultaneously
This is a hands-on position. Candidates should enjoy actually conducting clinical trials with frequent in-person participant interactions rather than primarily managing them from a desk.
ABOUT OUR CLINICAL RESEARCH PROGRAM
Cottonwood Endocrinology and Diabetes Care is an independent specialty endocrinology practice in Sandy, Utah, with an active and rapidly growing clinical research program.
Our research program is integrated directly into a large established endocrinology practice with approximately 12,000 patients, providing an exceptional environment for identifying and recruiting appropriate clinical trial participants.
Our studies include industry-sponsored pharmaceutical and medical-device research, primarily in:
- Type 1 and Type 2 diabetes
- Obesity and metabolic disease
- GLP-1 and other incretin-based therapies
- Dual- and triple-agonist therapies
- Diabetes devices and technology
- Immunotherapies for Type 1 diabetes and Graves' Disease
- Subclinical Cushing's Syndrome
The majority of our trials are Phase III, with selected Phase II studies involving more intensive study procedures and PK/PD assessments.
COMPENSATION & BENEFITS
$26–$32 per hour, depending on clinical research experience and qualifications.
Candidates with substantial Phase II/III site experience, strong phlebotomy skills, PK/PD experience, and the ability to independently perform complex study visits may qualify toward the upper end of the range.
Benefits include:
- Medical insurance
- Dental insurance
- Vision insurance
- Paid holidays
- Paid time off
- Ongoing exposure to innovative pharmaceutical and medical-device research
- Opportunity to grow with an expanding independent clinical research program
HOW TO APPLY
Please submit a resume that clearly identifies:
- Your years of clinical research experience
- Phase II and/or Phase III trials you have worked on
- Pharmaceutical and/or medical-device trial experience
- Your specific responsibilities at the study site
- EDC and sponsor/CRO systems you have used
- Phlebotomy and specimen-processing experience
- Experience with PK/PD or timed blood collections, if applicable
- Diabetes, obesity, endocrinology, or metabolic research experience, if applicable
Prior hands-on experience with industry-sponsored Phase II or Phase III clinical trials is required.
Skills
- Recruiting
- Aliquot
- Clinic
- Clinical Trial
- Diabetes Mellitus
- Endocrinology
- Metabolism
- Obesity
- Pharmaceutics
- Phlebotomy
- Specimen Processing
- Specimen
- Venipuncture
- IRB
- Pharmacodynamics
- Pharmacokinetics
- Phlebotomy Certificate
- Labelling
- Vendor Management
- Data Entry
- Detail Oriented
- Communication Skills
- Clinical Research
- GLP Compliance
- Documentation
- Vital Signs
- Medical Devices
- Compliance
- Time Management Skills
- Collaboration
About Cottonwood Endocrinology and Diabetes Care
Cottonwood Endocrinology and Diabetes Care is an independent specialty endocrinology practice in Sandy, Utah, with an active and rapidly growing clinical research program. Our research program is integrated directly into a large established endocrinology practice with approximately 12,000 patients, providing an exceptional environment for identifying and recruiting appropriate clinical trial participants. Our studies include industry-sponsored pharmaceutical and medical-device research, primarily in: Type 1 and Type 2 diabetes Obesity and metabolic disease GLP-1 and other incretin-based therapies Dual- and triple-agonist therapies Diabetes devices and technology Immunotherapies for Type 1 diabetes and Graves' Disease Subclinical Cushing's Syndrome
Pay: $26.00 - $32.00 per hour
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Application Question(s):
- Which types of industry-sponsored trials have you worked on?
Phase II Pharmaceutical
Phase III Pharmaceutical
Medical device
Phase I
Other
- Have you personally coordinated or conducted participant face-to-face visits for an industry-sponsored Phase II or Phase II clinical trial? (Yes or No)
- Have you entered clinical trial data directly into sponsor or CRO electronic data capture (EDC) systems and other study portals?
Yes-regularly
Yes-occasionally
No
- Have you been responsible for maintaining source documentation and responding to monitor or sponsor data queries (Yes or No)
- Have you interacted directly with sponsor/CRO Clinical Research Associates during on-site monitoring visits? (Yes or No)
- Can you perform phlebotomy reliably? (Yes or No)
- Do you have experience processing clinical research specimens, including centrifugation, aliquoting, labeling, freezing, packaging, or shipment to central laboratories? (Yes or No)
Experience:
- hands on industry-sponsored clinical research: 1 year (Required)
Work Location: In person
