Location: Malvern, PA
Reports to: Director, Clinical Operations
The Clinical Research Associate is a key member of the study management team and integral to the successful planning and execution of clinical studies. This individual will develop and maintain strong, productive relationships with both the clinical sites and CRO and is responsible for the oversight of clinical monitoring activities.
Duties and responsibilities
- Support study management team to ensure that studies are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines and government regulations.
- Assist study team(s) in the identification, feasibility assessment, qualification, and selection of clinical research sites.
- Drives the study start-up process in conjunction with the CRO ensuring timely submission of regulatory documents and completion of clinical trial agreements and budgets.
- Interface with clinical sites to ensure timely and accurate completion of study tasks including entry of study data and resolution of data queries.
- Interface with CRAs/CRO monitors ensuring CRA training, execution and reporting of monitoring visits and follow up on monitoring visit action items.
- Drive recruitment/retention follow-up with clinical study sites to support and achieve enrollment goals.
- Proactively identifies risks, developing and implementing mitigation plans as applicable.
- Draft or assist with preparation of study-related documents, tools and templates.
- Provides oversight of TMF including compliance with the TMF plan and TMF reconciliation.
- Liaises with CMC and vendors to ensure management of study drug supply including tracking and issue resolution.
- Participate in study and department meetings. Prepares agendas and minutes and maintains key decision and action item logs.
- May assist study team and department with financial tracking and reporting which may include coordination of CRO, vendor, and site contracts.
- May assist in developing policies and procedures (SOPs).
- Additional tasks and projects as requested.
- BA/BS degree, preferably in life sciences.
- 3+ years of progressive clinical research experience in the biotechnology/pharmaceutical industry with +2 years of experience as a Clinical Research Associate.
- Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 desired.
- Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.
- Demonstrated attention to detail and outstanding organization skills.
- Self-motivated with a commitment to high quality, on-time deliverables.
- Excellent communication and collaboration skills with a team-oriented approach.
- Experience with eTMF, CTMS and EDC.
- Demonstrated ability to identify and resolve issues and effectively manage timelines.
This position operates in an office setting and may include 20% of travel to visit sites, vendors or CROs. Job may require incumbent to be available outside of normal hours to handle priority business needs.
This is a largely sedentary role.
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