Full-Time Sr. Clinical Research Associate
Exciting opportunity for Senior Clinical Research Associates to be based at USAMMDA!
ClinicalRM is a full service Contract Research Organization (CRO) specializing in preclinical through Phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe, and respond rapidly to global health crises.
- Provide oversight and administrative efforts in order to efficiently and effectively monitor the clinical trial process.
- Verify and ensure that that the rights and well-being of the human subjects enrolled in the clinical trials are protected and that the reported trial data are accurate, complete, and verifiable from source documents.
- Ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with ICH current GCP, FDA CFR, USAMRMC, OTSG-DA, and DoD, along with other applicable Sponsor and regulatory requirements, requirements of host countries and other government regulations.
- Lead the development, coordination, and implementation of monitoring and administrative strategies essential to the successful management of clinical trials research.
- Conduct site pre-qualification and initiation visits; verifying that assigned research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout trials.
- Conduct on-site clinical monitoring that includes; protocol training prior to study start, document reviewing, ensuring accurate data recording, monitoring adverse events, concomitant medications, and inter-current illnesses and verifies they are reported in accordance with the protocol on the Case Report Form (CRF), verify patient data, ensuring adherence to the clinical protocol, site and Sponsor SOPs, investigational product accountability, verification of product shipping/storage conditions, etc.
- Conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report.
- SCRAs must work effectively as part of an Integrated Product Team (IPT) and act as the Sponsor’s liaison to resolve site related issues quickly and effectively.
- Prepare trip reports and recommend corrective actions, where appropriate, in accordance with USAMMDA SOPs.
- Maintain written or email communication as well as telephone communication with the clinical sites. Telephone communications will be documented in minutes.
- Participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval.
- Possess documented advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies.
- SCRA positions require travel 50-65% of the year.
- Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.Qualifications:
- Must possess documented advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies.
- SCRA positions may require travel up to 65% of the year.
- Must provide capability to learn, speak, write, and interpret foreign languages as appropriate.
- Must be able to work independently following a brief period of specific technical training.
Candidates must meet all stated minimum criteria, including US Citizenship, to be considered for this opportunity. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with Federal or State agencies will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer