Clinical Protocol Coordinator
Camris International

Bethesda, Maryland

Posted in Science and Research


Job Info


Overview

CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!

We are seeking a Clinical Protocol Coordinator to provide services in support of the overall functions of the Laboratory of Immunoregulation (LIR).

Responsibilities


  • Manage clinical protocols by assisting in training the study team and other staff members, oversees compliance to protocol, develop and adhere to relevant SOPs; manage quality control, completion and submission of study related documents; help in preparation, submission and maintenance of IRB, FDA, and/or other regulatory documents and research correspondence.

  • Assist in development of informed consent and screening materials. Schedule and oversee study visits to NIH as needed.

  • Interview, screen, recruit and enroll patients in IRB approved clinical trial protocols.

  • Obtain informed consent/assent and address complex ethical and legal implications of same.

  • Perform quality assurance and quality control activities as they relate to protocol adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety.

  • Use advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues.

  • Maintain study subject databases; oversee data collection and management including the collection of source documents, using, and developing CRFs, and ensuring that they are complete and accurate.

  • Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues. Assist with training staff members.

  • Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.

  • Assist with medical documentation. Recruit volunteers for all protocols and collect and report census for all open protocols.

  • Abstract medical information from medical history, medications, and preexisting conditions for new participants.

  • Build and maintain excellent communication with Principal Investigators and others needed to conduct quality research to foster an excellent reputation of site research.

  • Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in a timely fashion.

  • A ssist in data analysis and manuscript preparation.

  • Manage patient safety and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner.



Qualifications


  • Bachelor's degree in nursing.

  • Licensed as a nurse in the state of Maryland.

  • A minimum of 9 years of experience in clinical research setting with protocols and clinical trials is required.

  • Knowledge of federal regulatory requirements pertaining to clinical research.

  • Knowledge of Good Clinical Practice (GCP).

  • Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient's medical records.

  • NIH clinical trials experience preferred.

  • This position and duties may be conducted remotely upon approval.



CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson's Janssen, is required for this position.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.



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