Careers

JOB DESCRIPTION:

The Clinical Research Associate (CRA) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials.

ESSENTIAL DUTIES & RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Works with internal and external team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution
• Conducts study tracking and updates (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals
• Collaborates with the Clinical Team on the development of certain study-specific plans and/or processes
• Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
• Collects and reviews essential documents from investigational sites
• Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Participates in study specific tasks such as investigator identification, recruitment, collection of regulatory documents and site activation
• Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
• Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Assists with preparation of investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Assists in the organization and preparation of and participates in Investigator Meetings (as applicable)
• Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation
• Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed
• Ensures timely study entry and updates to ClinicalTrials.gov
• Assists with design and preparation of study related materials for the training of internal and external staff
• Assists with oversight of study vendors
• Participates in development of departmental processes, SOPs, and initiatives

Requirements:

• Bachelor’s Degree preferred
• Minimum of two (2) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
• Experience in scientific discipline and multiple therapeutic areas preferred
• Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process
• Proficiency in MS Office including Word, Excel, and PowerPoint
• Ability to work in a team or independently as required
• Effective written and verbal communication skills
• Critically evaluates job tasks and the impact on overall trial management objectives
• Sound problem-solving capabilities
• Good judgment in triaging issues from internal and external customers
• Effectively collaborates with Clinical Trial Team members
• Outstanding organizational skills with the ability to multi-task and prioritize
• Exceptional attention to detail

TRAVEL REQUIRED

• Available for minimal travel (<20%) including overnight stays, when required.
• Ability to drive and have a valid driver’s license.

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

JOB DESCRIPTION:

Demonstrated strength and success in project management to plan and align all activities required for clinical and preclinical stage therapeutic candidates. Ability to plan critical timelines, interdependencies and budgets. Facilitate the performance of cross functional project teams to develop products from pre-IND to Phase 3. Ensure effective outcomes throughout all phases of a project. Drive the development of high-quality and integrated cross-functional plans in support of the projects. Will apply best practices in the development, initiation, planning, execution, control and closing of project plans.

ESSENTIAL DUTIES & RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Oversees program plan development, tracks and updates milestones and key activities
• Establishes and maintains integrated project schedules to ensure accurate project, financial and portfolio analyses; aligns with functional partners and project sub-teams
• Collaborates with Clinical Development, Clinical Operations, CMC, Regulatory, Cancer Biology, Finance and Research in the preparation of budgets, other resources and costs
• Develops detailed project plans, milestones, timelines and corrective actions
• This person must build strong working relationships across departments, with key stakeholders and senior management
• Effectively communicates with all levels within the organization, documents and maintains project team outcomes, actions, activities and decisions
• Facilitates project team meetings, sub-team meetings and cross-functional information sharing and ensures alignment
• Organizes and facilitates Project Review of portfolio projects
• Identifies conflicting priorities across multiple project objectives and can articulate risks and trade-offs
• Builds and maintains strong relationships with a diverse set of internal contacts, including senior level executives
• Facilitates ongoing communication to understand key interdependencies, drive decision-making, issue resolution and execution across projects, as well as keeping all stakeholders informed and up to date on project details

Requirements:

• BS or BA in Life Sciences. An advanced degree, MS, MBA or Ph.D.is preferred; however, experience and accomplishment will be considered in lieu of advanced degree
• The preferred candidate would have a PhD in chemistry, biology or like science with excellent working scientific knowledge of all areas. He/she would have several years’ experience in biotech/pharmaceutical industry project management, particularly at the early to Phase 3 development stage and would have worked within the context of an active industry alliance
• Multidisciplinary knowledge of biotechnology/pharmaceuticals
• 5 years-experience in project management in support of drug development
• PMP and other certifications preferred
• Expertise and accomplishment in drug development methodology, to include project management practices, methodology and tools
• Demonstrated knowledge and in-depth working experience with MS Project and ancillary tools to manage budgets, timelines, metrics and outcomes
• Has financial acumen; can plan and manage budgets
• Excellent management, leadership and interpersonal skills
• Attention to detail, action oriented and outcome focused
• Strong written, verbal and platform skills

• Demonstrated experience within a regulated environment and knowledge of cGXPs, regulations and validation standards

TRAVEL REQUIRED

• Available for minimal travel (<10%) including overnight stays, when required.
• Ability to drive and have a valid driver’s license.

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.