Senior Clinical Research Associate
The Sr. Clinical Research Associate (CRA) is responsible for management and monitoring activities that will lead to successful execution of clinical studies. The position will monitor patient recruitment, data and study related information related to clinical sites and study participation. Ensures that duties are performed in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provides case support to research sites across multiple studies.
- Responsible for monitoring clinical studies, which includes the review of case report forms (CRFs) or electronic data capture (EDC), and source documentation to ensure adherence to the protocol and scientific validity of the data.
- Responsible for developing study specific monitoring tools and other related documents as needed.
- Responsible for reviewing and approving essential regulatory documents across multiple studies.
- Assists the project team in developing study metrics to ensure the efficient execution of a clinical trial as required.
- May support submission of trials to IRB/IEC and regulatory authorities.
- Ensures adherence to study timeline across multiple studies.
- Coaches and mentors less experienced CRAs and assist in their development and training.
- Maintains strong working knowledge of protocols and product development across multiple studies.
- Prepare and develop project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries, as required.
- Coordinate review of data listings and preparation of interim/final clinical study reports.
- Delivers high quality written monitoring reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.
- Demonstrates ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team.
- Demonstrates an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations.
- Verifies the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the study.
- Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
- Ensure compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies.
- May manage Protocol Deviation documentation, tracking, and escalation.
- Participates in site audits, as requested.
QUALIFICATIONS / EDUCATION:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Minimum BS/BA degree.
- At least 3 years clinical research experience as a monitor in the pharmaceutical, biotechnology or CRO industry.
- Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.
- Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and the ability to quickly become proficient in a variety of other computer software programs.
- Proficient in using EDC and CTMS.
- Working knowledge of FDA, European Regulatory and CE procedures, as applicable.
- Exhibits a strong knowledge base of medical terminology and pathophysiology.
- Ability to organize and take initiative.
- Excellent analytical skills.
- Clear and systematic thinking that demonstrates good judgment and problem-solving competencies.
- Excellent oral and written communication and presentation skills.
- Ability to work independently with minimal oversight as well as actively contribute to a project team.
- Flexibility in work hours and readiness to travel. Travel may be up to 75%.