Clinical Research 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 the West Coast Region so most likely located in California.
Assists the Clinical Research Director or designee with the 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).
Duties & Responsibilities:
- Provide input into the development of protocols and amendments.
- Prepare study specific informed consent form (ICF) template.
- Develop study conduct plans and templates where applicable (e.g. Monitoring Plan, Source Document Verification Plan, CRF Completion Guidelines, etc)
- Develop study specific tools for the sites and monitors.
- Develop patient education materials if needed.
- Coordinate development of potential investigator list for a given study.
- Coordinate feasibility assessments including the development of questionnaires, collection of responses and summarization of results.
- 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.
- May conduct monitoring visits (study qualification, study initiation, interim monitoring and close-out visits) as needed, prepare reports as per the Monitoring Plan and ensure timely resolution of issues.
- Participate in clinical vendor selection process when appropriate.
- Assist with the planning and execution of investigator/study coordinator/monitor meetings.
- Develop protocol specific CRFs and any other tools used to collect data (e.g. patient diaries).
- Ensure clinical and non-clinical supplies are available for shipment when required. Responsible for ensuring authorized sites always have supplies on hand during the treatment phase of the study.
- Participates in the selection and oversight of contract Clinical Research Associates (CRAs). Reviews reports and ensures timely resolution of issues.
- Initiate grant payment process ensuring checks are mailed to sites in a timely manner.
- Track protocol violations and deviations ensuring appropriate documentation is available.
- Ensure 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.
- Lead CRA team meetings, answers CRA study-related questions.
- Develop regular site newsletters.
- Ensure timely collection/review of case report forms and resolution of queries.
- Participate in the clinical review of study data; create and/or resolve data queries as needed.
- Attend clinical team meetings and provide updates as needed (e.g. status of site selection, site visits, site/CRA issues, etc).
- Create frequently asked questions (FAQs).
- Create protocol-specific close-out checklist for monitors and sites.
- Coordinate evaluation of site performance ensuring results are recorded in the investigator database.
May require up to 50% travel both domestically and internationally
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
· Theoretical and working knowledge of applicable GCP and ICH guidelines as well as basic 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.
· Positive, team-oriented attitude.
· Requires computer literacy 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, or any other protected category.