Clinical Operations Manager

Job Description

Job Description

About the Role:

The Clinical Operations Manager is responsible for daily clinic operations, administrative functions, and the management of office personnel. This role acts as a liaison between patients, medical staff, clinic staff, and management to ensure optimal clinic functioning. Additionally, the Manager plays an essential role in ensuring policies and procedures are followed, interpreting and communicating regulatory and protocol requirements, and ensuring that the clinic delivers exceptional patient care and functions efficiently.

Duties and Responsibilities:

• Manage and train clinic site personnel.
• Identify and implement strategies to expand the research capabilities at the site in alignment with the overall site business plan.
• Oversee the implementation and maintenance of ACN quality standards at the site, including reading, analyzing, and interpreting regulations, protocols, and procedures to ensure studies are conducted in accordance with ICH GCPs.
• Manage site budgets and expenses, including the analysis of figures, study costs, and other financial and operational data.
• Work with the Medical Director/PI to address any study and/or clinical quality-related matters.
• Ensure timely and appropriate communication with Sponsors and IRBs as necessary.
• Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfill any site resource needs that are necessary to successfully conduct and/or recruit research studies.
• Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing adjustments/modifications to recruitment strategies based on the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies.
• Read, comprehend, and communicate study protocols.
• Oversee SIV, PSDV, and IMV.
• Manage and facilitate study startup documentation, training, supplies, and timelines of study protocols.
• Develop and implement operational plans, timelines, and budgets for clinical trials.
• Share best practices with other ACN site locations with the goal of raising the overall level of operational competencies at ACN.
• Monitor study progress, resolve data issues, and prepare status reports for leadership.
• Work closely with CROs, CRAs, and IRBs.
• Maintain site regulatory files.
• Document temperatures for IP stored on-site.
• Audit study e-source documentation to comply with study protocols.
• Support audits and inspections.
• Monitor study metrics and key performance indicators (KPIs).
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree preferred in healthcare or equivalent clinical research experience.
• Minimum of 5 years of clinical management experience or equivalent applicable experience in the clinical research industry.
• Minimum of 3 years of experience working as a Clinical Research Coordinator required.
• Comprehensive knowledge of FDA, GCP, and confidentiality.
• Proven success in managing teams and working in direct patient care required.
• Proficient problem-solving skills and conflict resolution.
• Proficient in Microsoft Word, Excel, and PDF.
• Excellent verbal and written communication skills.
• A proven ability to constantly prioritize multiple projects in a rapidly changing environment.
• Must be comfortable with a rapid-growth company.
• Monitor project timelines and ensure milestones are met.

ACN does not provide visa sponsorship for this role. Candidates who will require immigration or visa sponsorship at any time now or in the future (including, but not limited to, H‑1B, TN, or STEM OPT training plans) are not eligible for this role.

Certificates, Licenses, and Registrations:

• CPR certification.
• Certified as a Medical Assistant or in Phlebotomy.
• IATA and GCP certifications.

Benefits: Medical, Dental, Vision, 401k, PTO and more!

Location: Monday – Friday / on-site / Houston, TX

About the Company:

At Alliance Clinical Network, our mission is to advance medical research by enrolling diverse populations in high-quality clinical trials. We are committed to maintaining the highest standards of integrity and excellence, and to ensuring that every participant receives respectful and compassionate care. We strive to build a tightly knit, supportive and collaborative environment where our team members can thrive and make meaningful contributions to human health.