Clinical Research Associate II

Overview

How would you like to grow your skills working for a mission-driven organization while playing an important role in doing more with life?  AlloSource is a BioTech company headquartered in Centennial, Colorado.

Here at AlloSource we’re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families, and helping patients heal through our innovative cellular and tissue allografts.  This takes a special person with a strong desire to help make a tremendous impact on people’s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life!  What better reward is there than knowing you contributed, in some way, to save or enhance a person’s life!   If this sounds like an organization you wish to be a part of, then we invite you to apply.

Summary: 

The Clinical Research Associate II is responsible for the planning, execution, and management of clinical research studies in adherence with GCP and all applicable regulations and guidelines. Develops credible relationships with opinion leaders, sites, and clinical investigators.  Acts as a liaison between AlloSource third-party vendors, CRO’s, labs, and IRB’s. Responsible for managing all project deliverables in accordance with established timelines and budgets. Contributes to the development of protocols, relevant study documents, clinical study reports, publications, and leads a clinical team.

Application Deadline:    May 24, 2024 (1:00PM MST)  

Pay:   $65,836  -  $84,398/yr. based upon relevant years of experience

Shift:    Monday-Friday 8:00am to 5:00pm

Benefits:   Medical, Dental, Vision, Life Insurance.  Click link for more benefits details:   https://cloud.3dissue.net/40523/40398/40838/101256/index.html.html

Location:      Remote

Essential Duties and Responsibilities:  

• Manage all aspects of the study monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study, initiation visit, conducting on-site and remote monitoring visits.
• Responsible for all aspects of site management as detailed in the project plans.
• General on-site and/or remote monitoring responsibilities.
• Ensure principal investigators and site research staff assigned to study have been properly educated and trained on protocol, have proper material to conduct study, and can safely identify and enroll patients.
• Ensure the protection of study patients by verifying informed consent process and protocols as defined by the regulatory requirements.
• Oversee preparation of Institutional Review Board (IRB) submissions and EC submissions, notification of regulatory authorities, translation of study related documentation, and communication to research study sites.
• Ensure the integrity of the data submitted on (electronic) case report forms by thorough verification of careful and complete source document review.
• Serve as a lead monitor for the project and assist in establishing monitoring plan.
• Monitor data for missing or implausible data and generate queries through resolution.
• Collect, report, and follow-up on serious adverse experiences at clinical research sites.
• Responsible for the oversight of the identification and selection process of investigator sites.
• Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments.
• Contributes to and authors clinical study documents, including but not limited to: protocol development, informed consent form, case report forms, clinical study reports, and publications.
• Participate in writing clinical trial reports as assigned.
• Collaborates cross functionally across the organization to achieve corporate goals.
• Develops credible relationships with opinion leaders, sites, and clinical investigators.
• Organize and make presentations at Investigator Meetings.
• Leads, influences, and project manages multiple studies that deliver positive patient and investigator site experiences and quality data.
• Develops and maintains clinical research operating processes, policies, and procedures in support of regulatory compliance.
• Perform interim statistical review and final analysis as assigned and prepare reports.
• Negotiate study budgets with potential investigators and assist in the completion of agreements as assigned.
• Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
• May perform other related duties and responsibilities as assigned.
• May travel up to 50% of the time. 

Requirements:

• Bachelor’s degree (BS or BA) or Bachelor of Science Nursing Degree (BSN)\
• 2-4 years of clinical trial experience within an FDA regulated industry, specifically tissue banking, medical device, biologics, pharmaceuticals, or CRO industries
• 3 years of project management experience
• Advanced site monitoring skills
• Advanced study site management skills
• Advanced regulatory administration skills
• Ability to work with minimal supervision
• Excellent planning and organizational skills
• Excellent verbal and written communication skills
• Experience working with cross-functional teams
• Ability to train and supervise direct reports
• Ability to resolve project-related problems and priorities workload for self and team
• Work efficiently and effectively in a matrix environment
• Independent, on-site, and remote monitoring experience
• Proficiency in Microsoft Office applications including Word, Excel, PowerPoint

Preferred Experience:

• Graduate degree (life science preferred)
• Project Management Professional (PMP)
• ACRP-PM
• Project Management Certification (PMC)
• Clinical Trial Certification (CCRA, CCRC, CRP)
• Direct experience with all aspects of Clinical Trial Management, and
• Indirect experience with related business functions (regulatory affairs, operations/manufacturing, research & development, marketing & sales)

Click Link for Full Job Description:     Clinical Research Associate II               

It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. When needed we will provide reasonable accommodations to qualified applicants and employees so that they may perform the essential job duties of the position. If you require special accommodations, please contact us at 720-873-0213. 

For consideration you must apply online, submit a current resume and meet the minimum requirements.  AlloSource is a Fair Chance Employer.  Candidates within a 50 mile radius of the hiring zip code may receive first consideration.

Equal Opportunity Employer/Veterans/Disabled

AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.