Study Coordinator

Overview

Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced Research Study Coordinator in Denver

Bring your established interventional trials research experience and join a team dedicated to providing an excellent experience to patients.

We realize that it sounds cliché but it is true - taking care of cancer patients is a calling. It’s much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment.

No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient’s hand, or a scheduler on the phone finding an appointment that fits into a patient’s schedule, we are deeply connected to our patients and do what we can to help.

If this sounds like you, we’d love to have you join our team.

Salary Range: $60,000-$75,000

Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; potential for research bonus depending on financials of department after one year of employment; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance.

A wide salary range is posted for this position and any job offer is based upon a salary analysis to comply with the Colorado Equal Pay for Equal Work Act. The salary analysis considers relevant experience, education, and certifications as compared to others doing substantially similar work. While all offers are compliant with the Colorado Equal Pay for Equal Work Act, there is no guarantee an offer will be at the top of the posted range based on the salary analysis.

Responsibilities

Position Summary

• Plan the execution and monitor the completion of more intense and complex assigned clinical research protocols. Including support of other research teams and monitoring adherence to the clinical protocol and preparing reports on the data.
• Work closely with the physician principal investigator, clinical trial sponsor and internal and external study teams for study operation.

Responsibilities

• Assists in the execution of highly complex trials for the research team. Trials assigned will involve complex protocol management and assisting the data management, clinical and regulatory research teams.
• Assist with the training of new Study Coordinators and Data Coordinators
• Initiate improvements, tools, processes, and forms to enhance efficiency and quality of work within the research department
• Planning and tracking of all assigned clinical activity in the lifecycle phases of the startup, interim and close out.
• Updates clinical teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments.
• Creates study specific tools for source documentation as well as checklists and clinic information documents
• Ensures study specific tools are updated with any amendment(s) or study changes.
• Participates as needed in monitor visits for each assigned trial at each monitoring visit.
• Reviews and comments on follow-up letters
• Assists with reviews of trial data for responses to queries.
• Provide required study metrics to leadership.
• Assists in physician oversight by updating on protocol issues
• Assists with sponsor and FDA audit preparation.
• Assists with reviews and responses to monitoring and auditing findings
• Participates in sponsor meetings as assigned.
• Adhere to professional standards and SOPs established for clinical research

Qualifications

Education

• Associate’s degree required, bachelor's degree preferred

Experience

• Minimum 3 years research experience on interventional trials

Working Conditions

Environment

•

Traditional office and clinical environment.

•

The work environment characteristics described here represent those an employee may encounter while performing essential job functions. Reasonable accommodations will be provided as needed.

•

Exposure to communicable diseases, toxic substances, medical preparations, and other conditions common to a clinical research environment.

Physical Requirements

•

Significant amount of computer‑based work required.

•

Requires standing and walking for extended periods.

•

Occasionally lifts and carries items up to 40 lbs.

•

Requires corrected vision and hearing within normal range.

•

Reasonable accommodations will be provided to enable individuals with disabilities to perform essential functions.

All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire.

We will be accepting applications on an ongoing basis for this position. To apply for this position, start the process by clicking the blue "apply"

Position Summary

• Plan the execution and monitor the completion of more intense and complex assigned clinical research protocols. Including support of other research teams and monitoring adherence to the clinical protocol and preparing reports on the data.
• Work closely with the physician principal investigator, clinical trial sponsor and internal and external study teams for study operation.

Responsibilities

• Assists in the execution of highly complex trials for the research team. Trials assigned will involve complex protocol management and assisting the data management, clinical and regulatory research teams.
• Assist with the training of new Study Coordinators and Data Coordinators
• Initiate improvements, tools, processes, and forms to enhance efficiency and quality of work within the research department
• Planning and tracking of all assigned clinical activity in the lifecycle phases of the startup, interim and close out.
• Updates clinical teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments.
• Creates study specific tools for source documentation as well as checklists and clinic information documents
• Ensures study specific tools are updated with any amendment(s) or study changes.
• Participates as needed in monitor visits for each assigned trial at each monitoring visit.
• Reviews and comments on follow-up letters
• Assists with reviews of trial data for responses to queries.
• Provide required study metrics to leadership.
• Assists in physician oversight by updating on protocol issues
• Assists with sponsor and FDA audit preparation.
• Assists with reviews and responses to monitoring and auditing findings
• Participates in sponsor meetings as assigned.
• Adhere to professional standards and SOPs established for clinical research

Education

• Associate's degree required, bachelor's degree preferred

Experience

• Minimum 3 years research experience on interventional trials

Working Conditions

Environment

•

Traditional office and clinical environment.

•

The work environment characteristics described here represent those an employee may encounter while performing essential job functions. Reasonable accommodations will be provided as needed.

•

Exposure to communicable diseases, toxic substances, medical preparations, and other conditions common to a clinical research environment.

Physical Requirements

•

Significant amount of computer‑based work required.

•

Requires standing and walking for extended periods.

•

Occasionally lifts and carries items up to 40 lbs.

•

Requires corrected vision and hearing within normal range.

•

Reasonable accommodations will be provided to enable individuals with disabilities to perform essential functions.

All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire.

We will be accepting applications on an ongoing basis for this position. To apply for this position, start the process by clicking the blue "apply"