Clinical Research Manager / Senior Clinical Research Coordinator

Job Description

Job Description

CLINICAL RESEARCH MANAGER / LEAD CLINICAL RESEARCH COORDINATOR
Endocrinology & Metabolic Clinical Research
Sandy, Utah | Full-Time | On-Site
Salary: $65,000–$80,000 per year, depending on experience

JOIN A GROWING ENDOCRINOLOGY AND DIABETES CLINICAL RESEARCH TEAM

A private endocrinology practice in Sandy, Utah, is seeking an experienced Clinical Research Manager / Lead Clinical Research Coordinator to lead the day-to-day operations of our expanding clinical research program.

This is an unusually hands-on leadership opportunity for an experienced clinical research professional who enjoys both independently managing industry-sponsored trials and leading a small research team .

Our research program is integrated directly into a large endocrinology practice with an established patient panel of approximately 15,000 patients , giving our research team exceptional access to potential study participants with diabetes, obesity, and other endocrine and metabolic disorders.

We currently have approximately five active clinical trials and expect to expand to approximately 8-10 concurrent trials . The majority are Phase III pharmaceutical and medical-device studies, with selected Phase II studies as well.

Our pharmaceutical research includes investigational therapies in diabetes and obesity, including injectable and oral GLP-1 receptor agonists and newer dual- and triple-agonist incretin therapies. We also conduct studies involving advanced diabetes technologies and medical devices, such as insulin pumps and continuous glucose monitors.

We are looking for an experienced clinical research professional who can assume substantial ownership of the program and help us successfully manage its continued growth.

WHAT YOU WILL DO

The Clinical Research Manager / Lead CRC will work closely with the Principal Investigator and will be responsible for the daily execution and coordination of multiple simultaneous clinical trials.

Responsibilities include:

• Independently coordinate multiple Phase II and Phase III industry-sponsored clinical trials
• Oversee day-to-day clinical research operations
• Serve as a primary site contact for sponsors, CROs, clinical research associates, central IRBs, laboratories, and study vendors
• Work closely with the Principal Investigator on study execution, recruitment, protocol compliance, and operational issues
• Participate in study startup and regulatory activities
• Coordinate site qualification, site initiation, interim monitoring, audit, and closeout visits
• Maintain regulatory binders and essential study documentation
• Manage EDC entry, source documentation, study logs, data queries, and sponsor action items
• Identify and recruit potential study participants from our established endocrinology patient population
• Conduct prescreening, screening, informed consent, enrollment, and protocol-specific study visits
• Develop and manage recruitment strategies and enrollment goals across multiple studies
• Perform protocol-required venipuncture and blood collection
• Process, centrifuge, prepare, store, and ship research specimens according to protocol and laboratory requirements
• Coordinate time-sensitive blood collection and specimen processing for pharmacokinetic and pharmacodynamic studies
• Maintain investigational product accountability and assist with study medication and device procedures as appropriate
• Monitor and document adverse events, serious adverse events, protocol deviations, and other required safety information
• Maintain high standards of ICH-GCP and FDA regulatory compliance
• Track study milestones, enrollment performance, outstanding queries, monitoring findings, and sponsor deliverables
• Identify potential study problems early and implement solutions before they affect timelines or data quality
  

LEADERSHIP RESPONSIBILITIES

This is not solely a coordinator position.

The successful candidate will also help lead and develop our clinical research staff.

Responsibilities include:

• Supervise and provide day-to-day direction to Clinical Research Assistants and other research staff
• Delegate study responsibilities appropriately while maintaining oversight of trial execution
• Train research assistants in clinical research procedures and study workflows
• Help train appropriate research personnel in venipuncture, specimen handling, processing, and shipping
• Develop efficient workflows that allow the research program to grow from approximately five to 10–12 active studies
• Help establish priorities across competing protocols, visits, recruitment goals, and sponsor deadlines
• Maintain communication between the research department, Principal Investigator, clinical practice staff, and administrative leadership
  

The Clinical Research Manager will participate with the Principal Investigator and practice leadership in study startup and operational planning but will not be primarily responsible for negotiating study budgets or contracts .

QUALIFICATIONS

Strongly Preferred

• 5 or more years of clinical research experience
• Substantial experience independently coordinating industry-sponsored clinical trials
• Experience with Phase II and/or Phase III pharmaceutical or medical-device studies
• Demonstrated ability to manage several active protocols simultaneously
• Experience communicating directly with pharmaceutical/device sponsors, CROs, and clinical research associates
• Strong knowledge of ICH-GCP, FDA requirements, informed consent, and human-subject research requirements
• Experience with central IRB submissions and regulatory documentation
• Experience with electronic data capture systems and sponsor portals
• Strong source-documentation and data-quality skills
• Experience preparing for and participating in monitoring visits
• Venipuncture and clinical specimen-processing experience
• Excellent organizational and time-management skills
• Strong written and verbal communication skills
• Ability to independently identify and solve operational problems
• Ability to lead and supervise less-experienced research personnel

Particularly Valued Experience

Experience in any of the following areas would be especially valuable:

• Diabetes clinical trials
• Obesity clinical trials
• Endocrinology or metabolic research
• GLP-1 receptor agonist or incretin-based therapy studies
• Diabetes technology or medical-device trials
• Phase II research
• Pharmacokinetic/pharmacodynamic studies
• Serial or timed blood collections
• Research laboratory specimen processing and shipping
• Lead CRC or Clinical Research Manager responsibilities
• ACRP or SOCRA certification

A bachelor's degree is welcome, but substantial relevant clinical research experience is more important to us than a particular academic credential .

THE PERSON WE ARE LOOKING FOR

The ideal candidate is someone who has progressed beyond simply completing assigned study tasks.

We are looking for someone who can walk into a busy research program, understand what needs attention, establish priorities, communicate confidently with sponsors and monitors, guide junior research staff, and keep multiple studies moving forward without requiring constant direction.

This person should be:

• Highly organized
• Detail-oriented
• Dependable
• Comfortable assuming responsibility
• Able to prioritize independently
• Professional with patients and sponsors
• Comfortable working closely with physicians
• Able to maintain composure when several studies have competing deadlines
• Interested in helping build and improve a growing clinical research program
  

For the right person, this position offers considerable autonomy and the opportunity to be an important part of the leadership team for our clinical research program.

WHY THIS POSITION IS DIFFERENT

Our research site is integrated into an established specialty medical practice rather than operating solely as a stand-alone research center.

With approximately 12,000 established endocrinology and diabetes patients , our research team has direct access to a large population of potential study participants with diabetes, obesity, and other metabolic conditions.

Our expanding portfolio includes cutting-edge pharmaceutical and medical-device research involving some of the most rapidly evolving areas of diabetes and metabolic medicine.

You will work directly with an experienced endocrinologist and Principal Investigator and will have meaningful input into how the research program operates and grows.

SCHEDULE

This is a full-time, primarily on-site position in Sandy, Utah .

A traditional five-day workweek is available.

There is also the potential for a four-day workweek , typically consisting of approximately four 10-hour workdays, depending on study schedules, participant visits, and operational needs.

Occasional flexibility may be required for protocol-mandated early-morning visits, extended study visits, timed PK/PD collections, sponsor visits, or other study-specific requirements.

COMPENSATION & BENEFITS

• $65,000–$80,000 annual salary, depending on experience
• Medical insurance
• Dental insurance
• Vision insurance
• 14 days of PTO annually to start , with PTO increasing based on tenure
• Paid holidays
• Potential four-day workweek
• Stable daytime medical-practice environment
• Opportunity for increased responsibility as the research program expands
  

HOW TO APPLY

Please submit a resume describing your clinical research experience.

Candidates are encouraged to specifically identify:

• Years of clinical research experience
• Phases and types of clinical trials coordinated
• Number of simultaneous studies managed
• Pharmaceutical and/or medical-device trial experience
• Experience with diabetes, obesity, or metabolic studies
• Experience supervising or training clinical research personnel
• Venipuncture and laboratory specimen-processing experience
• Phase II or PK/PD study experience
• ACRP or SOCRA certification, if applicable
  

We are particularly interested in experienced Clinical Research Coordinators, Senior CRCs, Lead CRCs, and Clinical Research Managers who are ready to assume substantial responsibility for the operations and continued growth of an established 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

Company Description

Cottonwood Endocrinology and Diabetes Care is an independent specialty endocrinology practice in Sandy, Utah, with an active and rapidly growing clinical research program.\n\nOur 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.\n\nOur studies include industry-sponsored pharmaceutical and medical-device research, primarily in:\nType 1 and Type 2 diabetes\nObesity and metabolic disease\nGLP-1 and other incretin-based therapies\nDual- and triple-agonist therapies\nDiabetes devices and technology\nImmunotherapies for Type 1 diabetes and Graves' Disease\nSubclinical Cushing's Syndrome