Clinical Research Associate, CA, TX, NJ
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 Clinical Research Associates in full-time positions in our Clinical Research department located in California, Texas and New Jersey
Responsible for site management for clinical studies and assists the Clinical Trials Manager or designee with the initiation, monitoring and other tasks associated with the study management of clinical studies; assists with planning, execution and completion of clinical studies within agreed upon timeframes and budget and in compliance with the currently approved protocol, ICH and GCP regulations as well as Aerie Standard Operating Procedures (SOP’s). May be responsible for more than one study. Some or all of the responsibilities may be delegated to a Contract Research Organization (CRO).
Essential Duties & Responsibilities:
- Act as the primary point of contact with assigned clinical study sites;
- Ensure study site compliance per ICH GCPs, FDA or local regulations;
- Understanding of SOPs and application of applicable therapeutic indications;
- Provide and document initial and ongoing clinical study training to study site personnel;
- Conduct monitoring visits (study qualification, study initiation, interim monitoring and close-out visits) as needed, prepare reports as per the Clinical Monitoring Plan and ensure timely resolution of issues;
- Ensure protection of study subjects by verifying informed consent procedure and study protocol procedures are conducted appropriately and in alignment with approved study protocol;
- Ensure the integrity of the clinical data via timely collection/review of source documentation, case report forms and resolution of queries.
- Ensure clinical and non-clinical supplies are available for shipment when required. Responsible for ensuring authorized sites have supplies on hand during the treatment phase of the study.
- Ensure appropriate investigational product and study supplies storage, tracking, accountability and reconciliation at the clinical site;
- Ensure timely communication of Serious Adverse Events (SAEs), are processed and closed in a timely manner and sites have followed their site-specific reporting requirements.
- Ensure also that SAE data is consistent with CRF data. Also, follow-up on adverse events and other safety issues related to the clinical study;
- Track protocol violations and deviations ensuring appropriate documentation is available.
- Participate in the clinical review of study data; create and/or resolve data queries as needed.
- Ensure appropriate record keeping at the clinical site + timely collection and submission of essential study documents to the Trial Master File or study team;
- Assist clinical site with audit preparedness;
- Prepare timely and accurate site visit reports as required per the Clinical Monitoring Plan;
- Attend clinical team meetings and provide updates as needed (e.g. status of site selection, site visits, site/CRA issues, etc).
- Develop patient education materials if needed.
- Assist with the development of potential investigator list for a given study.
- Assist with feasibility assessments including the development of questionnaires, collection of responses and summarization of results.
- Participate in clinical vendor selection process when appropriate.
- Assist with the planning and execution of investigator/study coordinator/monitor meetings.
- Coordinate evaluation of site performance ensuring results are recorded in the investigator database.
- May require up to 50% travel both domestically and internationally.
- Manage travel and expenses timely;
- May assist Lead CRA with the below
In addition to the above, may perform functional role of Lead CRA supporting Clinical Operations as follows:
- Participate in the implementation and execution of clinical trial activities from study planning to closure;
- Provide input to the development of the protocol and any amendments;
- Provide leadership and direction to CRA team members;
- Act as point of escalation for CRA team and study sites;
- Drafting and finalizing the Clinical Monitoring Plan (CMP) and customizations of site visit report templates, checklists, letters and site/monitoring tools, source documentation;
- Ensure compliance with the CMP;
- May assist with the development and design of additional study documents including but not limited to the Study, Country and/or Site Level Informed Consent Template, case report forms, CRF completion guidelines / instructions, data management plan, edit checks and conduct user acceptance testing (UAT);
- Training and management of the CRA team on clinical aspects of the study, oversee contract CRAs;
- Assist with development of regular site newsletters;
- Supports in the review of data trends and visit report issues identified for re-training of sites and/or CRA team;
- Assist with regional monitoring strategies and forecasting of site visits for CRA team in line with CMP to ensure staffing needs are met and any identified backlog is addressed;
- Review / finalize visit reports according to the CMP and outlined in the annotated report template;
Co-monitors with contract/CRO monitoring staff as needed to evaluate site/monitor adherence to protocols, review study progress, evaluate performance, provide monitoring support when needed, etc.
- Follows-up with CRAs regarding visit schedules, outstanding visit reports and follow-up letters;
- Tracks status of visit reports, action items and associated metrics;
- Supports Clinical Operations in the implementation of corrective actions for sites or CRA team;
- May act as primary contact for issues relating to monitoring and site issues identified and act as first in issue escalation to Clinical Operations Lead with proposed solutions, as applicable;
- Assists with creation and maintenance of frequently asked questions (FAQs);
- The task 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
CRA I – Minimum of 0 – 2 years experience in clinical research. Monitoring experience preferred.
CRA II – Minimum of 2 – 5 years experience in clinical research. Monitoring experience required.
CRA III - Minimum of 5 – 8 years experience in clinical research. Monitoring experience required.
CRA IV - Minimum of 8 - 10 years experience in clinical research. Monitoring experience required.
- Requires a Bachelor’s degree, R.N., or B.S.N. degree or equivalent. Relevant experience beyond the minimum requirement may be acceptable.
Knowledge & Abilities:
· Good knowledge of applicable GCP and ICH guidelines as well as understanding of the phases of clinical development.
· Knowledge of clinical monitoring and site management.
· Able to work independently. Receives little to no instructions on routine work; general instructions on new assignments.
· Strong interpersonal skills are required.
· Requires excellent written and verbal communication skills.
- Able to multi-task and prioritize appropriately to meet deadlines in a dynamic environment.
· Positive, team-oriented attitude.
Ability to work effectively in a team/matrix environment
· Requires computer proficiency in several software packages, especially Microsoft Office applications and database software.
Standard physical demands: sitting at desk, working at computer. Extensive travel required.
Standard office environment
To perform this job successfully, and 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.