Associate Clinical Project Manager

Position Summary:

The Associate Clinical Project Manager (ACPM) works to support a cross-functional team (i.e., Clinical Operations and Clinical Project Manager) and Investigational Sites to provide coordination and oversight of scheduled clinical activities. This position will assist in the management of project timelines, communication flow and deliverables, monitoring and reporting on projects, building site relationships, and helping facilitate project development during the project life cycle.

Essential functions of the job include but are not limited to:

• Assist clinical study and project management teams with all aspects of study site management from study start-up to close-out on various studies simultaneously.
• Preparation of essential document templates, binders, collection, and review. Perform study tracking to ensure study files are current, accurate and complete.
• Create and maintain central study files for the duration of the study including assisting in file review and reconciliation for audits, in addition to preparing study files for archival.
• Plan, organize, and execute project-specific meetings including but not limited to Precision-Client meetings, Site-Precision meetings, and PI meetings.
• Responsible for assisting in kit collection/supply assembly, tracking and shipping.
• Prepares correspondence, spreadsheets and presentations utilizing Microsoft Office Suite, for project specific studies.
• Develop and maintain project specific plans, documents, and tools for the Clinical Team.
• Take initiative to support the Clinical Operations team to ensure timely, successful activation of trial sites according to time, quality/scope, and budget parameters.
• Collaborate with the Clinical Project Manager (CPM) to facilitate cross-functional team and Client communications for proactive, study-wide problem-solving regarding study progress and trial issues during the study.
• Liaise with Internal and External customers/vendors to meet project specific goals and Client deliverables.
• Support Clinical Team Manager/Lead in the management of investigational sites to ensure compliance with the trial protocol, ICH-GCP and applicable regulations, as required by certain projects.
• Performs all duties in accordance with Precision’s SOPs, government regulations and Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
• Assist the clinical operations team by overseeing Statements of Work for assigned external sites.
• Assist the clinical operations team by developing project plans, project logs, and any additional project specific documents.
• Process site invoices and ensure appropriate communication with external sites in regard to finances.
• Communicate with external sites on project updates on a routine basis.
• Provide support and/or conduct SIV trainings for assigned external sites.
• Other duties as assigned.

Qualifications:

Minimum Required:

• Bachelor’s in Biology, Information Technology or related field or equivalent experience in the clinical research industry
• 1- 3 years of general working experience with 1 year focused on project management or equivalent experience (i.e., clinical research assistant, CRC, phlebotomist, or equivalent)

Other Required:

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint).
• Able to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals; to write routine reports and correspondence; to speak effectively before groups of customers or employees of organization.
• Must possess a customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Demonstrates knowledge of ICH-GCP, and regulatory guidance, as well as the ability to implement
• Resolves project related problems and prioritize workload to meet deadlines with little support from management.
• Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment.
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Excellent communication skills (verbal and written) and collaborative working style Possesses practical knowledge of IT tools and systems in use on project team, particularly the MS Office suite, version 2010 or more recent.
• Ability to fulfill the clinical operations and data management roles with Precision Biospecimen Solutions.
• Must be able to read, write, speak fluently and comprehend the English language.

Preferred:

• 3 years of combined project or data management experience in translational sciences, translational medicine, information technology, laboratory services, clinical trial services, software development, or related field.
• Industry experience preferred.
• Experience with creating project plans and Gantt charts in at least one project management software tool.
• Familiarization with terminology used in immunology, molecular biology or genetics.
• Experience writing and executing Project Plans, CRFs, and other clinical documents.
• Project management certification (PMI, PMP) desirable.
• Candidates familiar with GLP, GMP, GCP, CLIA, and ISO regulatory guidelines.
• Continuing education courses toward Master’s Degree in a clinical, scientific, or related field preferred.

Last updated on Aug 28, 2024