Clinical Operations Manager I

CPC Clinical Research • Aurora, CO

3d • $61,114 - $73,337 • Hybrid

About The Position

We are looking for an experienced Clinical Operations Manager I to join our team! This role is ideal for an individual who can motivate teams to do great work collaboratively in order to produce the best quality outcomes possible. CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials. CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. CPC is dedicated to the principles of equal employment opportunity (EEO). CPC prohibits unlawful discrimination against applicants or employees on the basis of age 40 and over, race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, sexual orientation, gender identity, gender expression, color, religion, creed, national origin, ancestry, disability, military status, genetic information, marital status, or any other status protected by applicable state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at [email protected].

Requirements

• Nursing degree or BA/BS in a scientific field (or equivalent knowledge/experience)
• 3 years of experience in a clinical research setting (required) or 1 year of experience as a Research Assistant (required)
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
• Proficiency in Microsoft Office, particularly Outlook, Word and Excel.
• Excellent communication and organizational skills.
• Great attention to detail.
• Ability to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner.
• Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.
• Willingness to travel up to 25%.
• Viable applicants will be required to pass a background and education verification check.

Nice To Haves

• Experience with clinical site startup preferred.

Responsibilities

• Manage site identification and evaluation.
• Develop or review essential study documents including protocols, case report forms (CRFs), source documents, project management plans, monitoring plans, reference tools, and study manuals.
• Review site regulatory documents for compliance with CPC Standard Operating Procedures (SOPs) and applicable laws, regulations, and guidelines and to facilitate approval of investigational product release.
• Prepare central IRB submissions and resolve IRB issues.
• Manage site enrollment and study subject tracking and payments.
• Assist with the monitoring of project deliverables and project timelines.
• Develop and distribute project documents (e.g. safety reports, lab reports, deviations reports, monitoring reports, follow-up letters, meeting minutes, newsletters, and regulatory documents)
• Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.
• Provide investigational product or device tracking and disposition as required by project.
• Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services.
• Track and approve vendor payments.
• Manage multidisciplinary project team members in relation to their role on assigned projects. Proactively identify issues and discuss resolutions with applicable department heads, project team, CPC executives and/or the sponsor. Track implementation of resolution through to completion and efficacy checks.
• Ensure that the overall quality of project services and deliverables is maintained.
• Provide status reports on all projects.
• Participate in both onsite and offsite investigator meetings and training sessions.
• Escalate budget, proposals and change orders discussions to Business Development.
• Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.
• Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Routinely advise management regarding the overall project status.
• Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.
• Schedule project team meetings and prepare meeting agendas and minutes as needed.
• Perform other non-project related general administrative tasks such as filing, copying, faxing and shipping for assigned projects.
• Cross-train within the project team, as needed.
• Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.
• Provide timely feedback on the progress of project assignments; help assess project issues and propose resolutions to the CPC project lead.
• Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.
• Oversee SAE process and assure execution of safety plans.
• Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites.
• Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.
• Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.
• Manage the acquisition and supply of project specific materials to study sites.
• Provide feedback to study sites on tracing and quality issues, as required by project.
• Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
• 11 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree