Senior Clinical Research Associate
We are seeking an a Clinical Research Associate with a minimum of 5 years of experience to be responsible for assisting with the implementation of clinical research projects.
- Prepare and conduct study initiation, closeout, and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols, and project plan in accordance with FDA regulations.
- Review, track, and manage study documents (Case Report Forms (CRFs), Serious Adverse Event (SAE) reports, clinical notes, and enrollment logs) for accuracy and completeness, as well as query resolution.
- Responsible for one or more protocols with multiple sites to ensure compliance with Good Clinical Practices (GCPs) and study procedures; including investigator selection, reviewing regulatory documents, and preparing reports while meeting timelines/milestones.
- Set up the study sites ensuring each site has the staff training to trial-specific industry standards, the required clinical trial materials, and the study specific regulatory documents.
- Monitor clinical studies to ensure the quality and integrity of data entered in study documents verified against source documentation on-site.
- Ensure all study drug shipments and study trial supplies (used and unused) are accounted for.
- Update all relevant study tracking system on an ongoing basis.
- Assist Clinical Safety Manager in the collection and timely resolution of SAE reports.
- Assist Clinical Trial Associate with maintaining site and master study regulatory binders and study documentation.
- Draft, compile, and verify clinical data for status reports when required.
- Support compliance with study timelines.
- Assist the Director of Clinical Research in preparing the necessary tools to maintain consistency in the study data across all sites.
- Interact with sites to discuss study specifics, assist with IRB submission, oversee study start-up activities, etc.
- Assist in the design of the CRFs.
- Field phone calls and e-mails from sites and address issues in a timely manner.
- Assist the Data Management group as needed to resolve queries, etc.
- Make grant payments to clinical sites.
- Mentor junior staff members, as applicable.
Salary will be commensurate with experience, plus a comprehensive benefit program.
- Bachelor’s degree in biological science (nursing or other health-related discipline preferred) and a minimum of 5 years related experience and/or training; or equivalent combination of education and experience. A medical or healthcare background is critical to success in this position .
- Experience with all phases of clinical trials, particularly Oncology, first-in-man, Phase I/II trials; including investigational site management, data collection, and study protocol compliance.
- Knowledge of GCPs and regulatory requirements.
- Experience in clinical data interpretation and verification.
- Ability to understand medical terminology, read medical records, and understand medical abbreviations.
- Excellent verbal and written communication skills.
- Detail oriented with strong organizational, follow-through and problem-solving skills.
- Ability to assess priorities and consistently meet deadlines while being self-motivated with the demonstrated ability to work independently.
- Proficiency in Microsoft Office applications.
- 50-75% overnight travel but the position will be based out of Morris Plains, NJ when not traveling.
Local candidates preferred. No relocation assistance is available for this opportunity.
United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.
Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without salary information will not be considered.
Immunomedics, Inc. - 8 months ago