Job Description

Ascentage Pharma (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. Ascentage Pharma is proud of its collaborative and supportive culture, unified by a shared desire to develop therapeutics that will have a positive impact on patients’ lives. Ascentage Pharma is a dynamic and fast-paced organization that has been responsive to the needs of individual employees throughout its history. The company is defined by a shared understanding that it succeeds in advancing its mission only as each experience’s success in their role.

The Opportunity: Clinical Project Coordinator

• Department: Clinical Operations
• Reports To: Clinical Trial Manager or Director of Clinical Operations
• Job Type: Full-time
• Location: Remote/hybrid Local Candidates Preferred

Job Description Summary

The Clinical Project Coordinator (PC) will participate in the preparation and execution of Phase I-IV clinical trials from study start-up to close-out. Primary responsibilities include maintaining Trial Master File (TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, assisting with site management, initiating collection of start-up and key regulatory documents, and reviewing and tracking of essential documents throughout the life of the trial. Contributes to the production and distribution of study materials and site/study communications. Responsibilities will vary slightly based on whether the study is insourced or outsourced and the lifecycle of the study (start up, maintenance, close out).

Primary Duties and Responsibilities

• Provides administrative support for study team members including courier shipments, photocopying, organization of meetings and teleconferences, generation of meeting minutes, and tracking action items
• Supports site activation through collection, review, and tracking of study documents including confidentiality and investigator agreements, feasibility questionnaires, site regulatory documentation, and other study documentation as needed
• Contributes to SOP development and review
• Assists with the creation of study-specific documents and materials
• Collaborates with contracted vendors, including but not limited to Clinical Research Organizations (CROs), central laboratory, etc.
• Maintains tracking of site contact details and provides updates as needed to vendors
• Review invoices for clinical sites and vendors ensuring all are reviewed on time while adhering to strict compliance guidelines and playing a key role in budget tracking
• Assists with tracking and shipping of biological samples, as needed
• Assists in production of study specific documentation including correspondence, newsletters, site investigator binders, pharmacy manuals, etc.
• Establishes and maintains the study-specific TMF and associated electronic archives including performing TMF QC as appropriate
• Establishes and maintains the CTMS
• Attends study-related, company, departmental, and external meetings, as required
• Ensures internal and study-related trainings, for both the PC and the study team, are completed per Ascentage Pharma and study timelines
• Ensures all study deliverables are completed per Ascentage Pharma and review schedules
• Identify clinical trial issues and/or risks within the TMF, CTMS, and other study systems as required
• May provide oversight of clinical supply vendor(s) to ensure proper management of clinical supply shipments and inventory tracking
• Assists with tracking study metrics including patient screening and enrollment, data entry, query resolution, etc.
• May directly facilitate resolution of study related issues through communication with investigator site personnel and clinical trial vendors including central laboratories, CROs, etc.
• Performs other duties, as requested

Knowledge/Skills/Abilities Required

The minimum level of education and years of relevant work experience:

• Associate’s or bachelor’s degree in nursing, life science, or related field, or equivalent education/training
• 2-3 years clinical research experience (e.g. pharmaceutical, biotechnology, CRO and/or healthcare setting)
• Recent experience in oncology phase 1-2 trials is preferred
• Experience with insourced and outsourced studies is preferred
• General knowledge in clinical research operations, including FDA regulations/GCP/ICH guidelines
• Demonstrated ability to form strong functional relationships
• Effective oral and written communication and interpersonal skills
• Ability to interact with all levels of staff to coordinate/execute study activities
• Ability to think critically, identify root causes, and formulate potential solutions proactively
• Ability to handle several priorities within multiple, complex trials
• Strong attention to detail and accuracy, timeliness, self-motivation, developed organizational skills, and ability to work both as part of a team and independently
• Ability to work productively in a matrix team environment in a growing and changing environment
• Knowledge of electronic data capture including basic data processing functions
• Working knowledge of TMF maintenance and management of essential documents
• Computer skills including high proficiency in the use of a laptop computer and Microsoft Office Suite: Outlook, Word, Excel, and PowerPoint

Job Location

• The position is based in Rockville, MD
• Local DMV applicants strongly encouraged to apply
• Remote and Hybrid Applicants are welcome

Why Join Us- Our Value Proposition

This is a rare opportunity to shape the clinical vision of a public biotech at a pivotal growth moment—and see your work make a tangible impact for patients.

If you want to do something that matters—this work matters. Patients drive our passion to pioneer novel cancer therapies. Creating and delivering life-changing medicines requires focus, dedication, and heart. We hire exceptional people, trust them to do their best work, and support them with the resources and flexibility to thrive.

Compensation and Benefits

Ascentage Pharma offers an extremely competitive compensation package, including annual bonus. Actual pay is based on factors such as location, experience, skills, education, and internal equity. .and an equity-based compensation component, and a comprehensive benefits package which includes:

• Medical, Dental, and Vision Insurance, two types: PPO (Preferred Provider Organization); H.S.A. (Healthcare Spending Account), and reimbursement accounts such as H.S.A. FSA (Flexible Spending Account) and Dependent Care too.

Ascentage also offers:

• Life Insurance, Critical Illness, Company Paid Short- and Long-Term Disability (STD & LTD), Voluntary Accident Insurance, even Identity Theft and Pet Insurance.
• 401K Retirement, with generous company match (immediate vesting).
• We have a liberal Paid Time Off Policy
• Flexible schedules for staff, EAP
• Exciting, supportive, and intellectually challenging global work environment.
• Generous PTO and holidays encourage balance and recharge.
• A culture of engagement, diversity, inclusion, and empowerment.
• Flexibility to work onsite, remotely, or in a hybrid model.

Culture

At Ascentage Pharma, we strive to create a culture based on personal and professional growth and opportunity, focusing on these principles:

• Establish a collaborative, energized, and fun work environment where people are empowered and supported in the achievement of their career goals. Working at Ascentage allows you to balance your priorities.
• Create a diverse and multi-disciplinary workforce where all levels of within the organization are empowered to lead, welcomes innovation, and supports your career goals.
• Hire dedicated, talented, and entrepreneurial people who are passionate about achieving excellence in all they do every day, have a commitment to science and to the patients we serve.

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