Clinical Trial Associate
Inspiration, imagination, and innovation. Here at Aerie Pharmaceuticals, we share this passion for finding new approaches to protecting vision. United by great science, deep clinical insight, and a singular focus on your ophthalmic needs, we see the possibilities ahead and invite you to join us in creating the future of eye care.
Aerie Pharmaceuticals seeks qualified candidates for a full-time position in our Clinical department located in Bedminster, NJ.
The Clinical Trial Associate (CTA) is a critical member of the project team. The CTA assists the Clinical Operations Team with all aspects in the administration relating to clinical trial conduct according to International Conference of Harmonization (ICH), Good Clinical Practice (GCP), Code of Federal Regulations (CFR) and company Standard Operating Procedures (SOP). The CTA assist the Clinical Operations Team with the management of clinical studies from study implementation (start-up) to study close-out.
Some or all the responsibilities may be delegated to a Contract Research Organization (CRO).
Essential Duties & Responsibilities:
- Maintaining the Trial Master File (TMF) and assisting with site management, initiating the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings.
- Assists the study teams with site communications for various purposes – this includes feasibility/site identification activities and site updates.
- Performs study start-up activities which includes but is not limited to review of informed consents, development and review of study reference plans and manuals; distribute, collect and conduct quality review of clinical study site documents.
- Responsible for the submission of study documents to ethics committee and/or competent authorities; works as a liaison with review boards and independent ethics committees in the regulatory approval process.
- Assists with the creation and maintenance of study-specific documents, tools and materials and the procurement of study supplies.
- Provides study materials and supplies to the study sites and Clinical Research Associates (CRAs).
- Assists with tracking of clinical study progress including the creation and maintenance of study related trackers and status reports
- Participates in clinical team meetings – coordinates teleconferences / webinar and assists with the preparation of agendas, minutes and tracking of action items
- Prepares for and attends Investigator Meetings, as required. May participate in clinical vendor selection process, as required.
- Performs review of clinical data listings, as required
- Under general supervision, manage third party vendors in the every-day conduct of a clinical trial (central lab, reading center, IRB)
- May act as mentor and train less experienced CTAs.
- Maintains completion of company and study-specific trainings such as SOPs, policies, study plans and documents by due date
- May participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs)
The tasks and duties listed above are not all inclusive and Aerie may assign other responsibilities not listed as per discretion with little or no prior notice.
Education & Experience:
Undergraduate degree, science or health-related field. Prior experience in pharmaceutical, biotechnology or contract research organization (CRO) company preferred.
Requires minimum 4 - 6 years’ experience in clinical research.
Knowledge, Skills & Abilities:
- Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form.
- Demonstrate high ethical standards for honesty, truthfulness and integrity.
- Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines, as well as basic understanding of the phases of clinical drug development and clinical operation processes.
- Ability to receive general instructions on all new assignments and perform routine work with minimal or no supervision.
- Strong sense of urgency, organizational skills with attention to detail and ability to follow through on assigned tasks.
- Proficiency in computer literacy in several software packages, especially Microsoft Office applications (Word, Excel) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
- Enthusiastic team player and ability to work effectively in a team/matrix environment
- Ability to handle multiple tasks and deliver assigned tasks with quality and within specified timelines
Standard physical demands: sitting at desk, working at computer
Minimal travel required.
Standard office environment, two - fifteen floors with stairs and elevators.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.