Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at USAMMDA . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.
We are currently seeking a Senior Clinical Research Associate for the Frederick, Maryland area.
- Provide oversight and administrative efforts in order to efficiently and effectively monitor the clinical trial process.
- Verify and ensure 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 document
- 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.
- C onduct 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 (Deliverable 13) 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.
- The contractor shall learn and speak foreign languages as appropriate. One SCRA shall be located in close proximity to clinical sites in Thailand and shall be fluent in written and verbal Thai.
- This individual will be provided with a government furnished office.
- The contractor will provide a newly purchased laptop from Thailand to the Senior Clinical Research Associate located in Thailand.
- Because of the frequency of travel, the other SCRAs may be located outside of the USAMMDA office within the continental United States, utilizing a home office.
- 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.
- Performs light duties and other related duties as required and assigned.
- The contractor shall possess a bachelor’s degree in Science/Health-related field (i.e. Nursing, Medical Terminology, Biology or Biochemistry) or equivalent education, or equivalent experience. A master’s degree (within similar fields) is preferred and will equate to 1 – 3 years of experience.
- The contractor shall possess 7-10 years of experience in clinical trial monitoring, or appropriate experience transferred from related occupation such as RA Specialist, Quality Assurance Specialist, Site Coordinator etc. related to clinical trials research.
- Certification as a Certified Clinical Research Profession (CCRP) or Certified Clinical Research Associated (CCRA) is preferred.
- These positions are considered Key Personnel as defined in Section 1.5.7.
- Must be able to work independently following a brief period of specific technical training.
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 the Department of Defense (DoD) 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
“NorthCoast 99” Best Places to Work recipient
Clinical Research Management - 23 months ago
ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.