Contract Clinical Research AssociateBookmark This
Clinical Research Management
Silver Spring, MD
Growing and well-respected biomedical (clinical, basic and applied) research firm has openings as Monitors in Ohio and Maryland . 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 Contract Clinical Research Associate for the Cleveland, Ohio and various locations in Maryland area.
Participates in ongoing protocol and CRF training at the site.
Participates in the generation of study specific monitoring plans.
May participate in the development of protocols and CRFs.
May develop materials for the site reference manual.
May assist with the development of site training materials.
May participate in the identification and recruitment of investigators, collection of essential documents and complete prestudy visits.
Participate in investigator and site initiation meetings, tracks progress of identified studies.
Performs on-site and remote monitoring activities, ensures protection of research subjects by verifying informed consent and protocol requirements are met.
Source document review, identification and follow up of SAEs, site document review to ensure complete and up to date throughout study.
Assesses accuracy of investigational product accountability, completes monitoring reports, follows ClinicalRM SOPs, ICH Guidelines and FDA regulations
4 year college degree, health sciences preferred.
4 years clinical research experience with two of these years as a clinical research associate.
Experience monitoring Phase I-III studies.
Knowledge of ICH guidelines and GCP.
Detail oriented, proficient computer skills.
Ability to travel depending on contract up to 60%.
Excellent verbal and written skills.
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