Clinical Research Associate
Proclinical is recruiting for a remote based Clinical Research Associate for a leading pharmaceutical company. As the CRA, you will assist the Clinical Trial Managers with achieving key study parameters including, but not limited to, clinical study start-up activities, study execution, data collection, and close-out.
- Perform qualification, initiation, interim, and close out visits in accordance with established SOPs.
- Complete monitoring visits and submit visit reports in accordance with Clinical Monitoring Plan.
- Perform Protocol and Study related training.
- Accountable for the collection of documents for, and maintenance of, the electronic Trial Master Files (TMF) in accordance with SOPs
- Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines.
- Manage site and study progress by tracking IRB submissions, regulatory documents, start-up activities, enrollment, CRF completion, and query resolution.
- Attends Investigator Meetings and study-specific training for assigned trials.
- Develops and maintains collaborative working relationships with clinical investigative sites.
- Conduct meetings with the Investigator and Study Coordinator at each site visit and with other key staff, as needed.
- Communicate with the investigator and site staff as necessary to address questions, issues, or provide information.
- Complete IP accountability reviews and ensure that IP is stored and dispensed properly.
- Identify, analyze, and report serious compliance issues and develops action plan for approval.
- Perform Source Data Verification per Clinical Monitoring Plan.
- Understands assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
- Assist the Clinical Trial Managers with development of study plans, informed consent documents, case report forms (CRFs), site source documentation, etc.
- Perform co-monitoring visits with contract CRAs to ensure quality of monitoring; provide training and guidance as needed.
- Other tasks and responsibilities as needed.
Skills and Requirements:
- At least 1-2 years of independent monitoring experience
- Open to CRO or Sponsor Pharmaceutical backgrounds
- National Travel- 60% in peak periods, with an average of 30-40%
- Therapeutic area: Pain Management (non-opioid)
If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.