Location
Aurora, CO | United States
Job description
Full job description
We are looking for a Clinical Trial Manager II to join our team!
Are you well organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations.
Remote candidates are welcome to apply.
In this position you will:
- Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable.
- Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.
- Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.
- Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.
- Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.
- Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements.
- Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.
- Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues.
- Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.
- Oversee and approve site activations and IP release.
- Participate in project-related and other departmental/CPC meetings as required.
- Oversee the selection of qualified sites and Investigators for participation in research protocols.
- Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.
- Oversee project specific training of site staff.
- Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.
- Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities.
- Work closely with other team members to ensure timely resolution of site issues.
- Conduct drug tracking and disposition as required by project.
- Overseeing remote monitoring.
- Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations. Conduct site monitoring visits or co-monitoring visits, as needed.
Here’s what you will need to bring to the table:
- Nursing or bachelor’s degree preferred.
- A minimum of 3 years of experience in clinical research setting required.
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
- Thorough understanding of the drug development process.
- Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).
- Experience with electronic data capture systems.
- Excellent interpersonal communication skills, organizational skills and a great attention to detail. Ability to organize and instruct staff, while promoting group effort and achievement.
- Ability to carry out multiple tasks simultaneously.
- Ability to complete tasks in an accurate and timely manner.
- Ability to manage conflicts and resolve problems effectively.
- Ability to discern priorities with minimal direction to accomplish day-to-day tasks. Willingness to travel up to 25% of the time.
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $72,000 - $88,000 annually
Deadline to Apply: April 1, 2024
About CPC:
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 offers:
- 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)
- In-suite exercise and relaxation room
- Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
- Flexible and remote work schedules
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, 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].
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