Clinical Trial Associate
Department: Clinical Operations
Reports to: Sr Clinical Project Manager or Clinical Project Manager
Reporting to the Sr. Clinical Project Manager or Clinical Project Manager, this position coordinates various multi-disciplinary functions to meet clinical trial objectives. The Clinical Trial Associate is a key support role to senior Clinical Operations staff for NeuroBo sponsored clinical trials.
The Clinical Trial Associate will work closely with Clinical Operations’ Clinical Project Management to assist with various clinical operations project-related activities within established protocols, under general supervision.
S/he will have regular and frequent interactions with contract research organizations, clinical site staff, and third-party vendors to ensure effective project execution. The Clinical Trial Associate will provide clinical trial coordination support including clinical status tracking, in-house site management and data review activities in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice, and may be responsible for managing startup activities, vendor communication, or other project activities as assigned.
At the departmental level, the CTA will contribute to the development and revision of relevant SOPs and internal processes.
Role & Responsibilities:
Use technical knowledge and experience to work with the Clinical Project Manager (CPM / Sr. CPM) and others as required to proactively identify and anticipate issues and develop possible solutions
Maintain a thorough understanding of assigned protocol(s)
Liaise with vendors as directed to ensure project deliverables are met by identifying deliverables and methods of communication to facilitate efficient work flow; may manage vendors or portions of vendor responsibilities as assigned
Day to day contact with CRO and/or sites; identify potential issues / problems and escalate to CPM / senior CO staff
Assist in the development and responsible for maintenance of clinical documentation such as clinical protocols, study-related documents, plans, manuals and tools, including version control, and reviews documents for completeness, accuracy, and compliance with protocol and applicable regulations, with some oversight from the Clinical Project Manager or delegate
Organize, manage, and prepare trial documents related to study tracking and reporting and submit to the Trial Master File within established guidelines
Prepare and/or manage study communications including newsletters and study updates
Assist with maintenance of the study Trial Master File including archival, based on applicable guidelines and procedures
Assist with accurate preparation and review of external and internal documentation for assigned trials
Assist Sr./CPM in the oversight of the CROs by reviewing, critically assessing, and documenting findings for site management activities (for example, regulatory packets, monitoring visit reports, deviation logs, site visits, and study metrics as needed to ensure that patient enrollment and other site activities are on track and meet quality expectations) and discuss findings with Sr./CPM
Ensures and verifies that data and documentation collected in trials is aligned with protocols and site specifications
Conduct and document results of quality control reviews, ensuring necessary corrective actions are completed and identifying and resolving systematic issues
Participate in and contribute to study and program specific meetings (prepare agendas, record and disseminate meeting minutes when necessary)
·Assist the Sr./Clinical Project Manager in preparing necessary tools to maintain consistency in the trial processes and data across all trial sites
Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
Oversee/track delivery and receipt of required supplies and materials to study sites and provide regular status updates
May assist in the coordination and tracking of clinical supply shipments
Responsible for study laboratory sample management, including tracking and vendor management support
Coordinate and review trial project payments (investigator and/or vendor) and vendors as appropriate
Assist in reviewing responses to Data Correction Forms (DCFs) and track DCF follow-up and completion activities
May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the clinical trial
Ensures that delegated components of clinical trials are executed to expected and specified quality standards and study deliverables are met
Builds on basic knowledge of clinical trial operations under some direction and guidance of senior staff, but is largely self-directed; works independently but knows when to involve/collaborate with others
Learn best practices clinical operations methodologies, systems and processes, with particular emphasis on quality, time and budgeting standards and expectations
Participates in identification of opportunities for improvement, creating standardized study tools and processes, and creation of departmental SOPs
Displays ability to independently solve routine problems following standard policies/procedures
Additional responsibilities as assigned
Bachelors’ degree in scientific/clinical related discipline and at least 2 years of relevant work experience in clinical trial support, data coordination, or a pharmaceutical or CRO environment
Working knowledge of industry standards including ICH guidelines, GCP, compliance, and the CFR
Functions independently with oversight and willing to “wear many hats”
Strong written and verbal communication, organizational, and interpersonal/team skills
Proficient in MS Excel, Word, and PowerPoint.
Excellent time management skills, ability to organize and prioritize workload, attention to detail, and demonstrated ability to multi-task
3+ years of relevant industry experience
Strong interpersonal and communication skills and have a proven work ethic
Effective problem-solving skills
Knowledge of MS project preferred
Experience in review of clinical trial documentation (e.g. informed consent documents, regulatory packets, monitoring reports)
Small pharma experience preferred
Experience with pain or CNS trials preferred
Work Environment: Office
Physical Demands: Occasional overnight travel
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
To apply, please send an email with your resume and cover letter to firstname.lastname@example.org.