Clinical Research Associate II (CRA II)

Frederick National Laboratory for Cancer Research; United States; Remote; USD 74,000 - 129,000; Full time

Job summary

The Frederick National Laboratory for Cancer Research seeks a Clinical Research Associate II to oversee clinical trials, ensuring adherence to protocols and regulatory guidelines. This remote position requires a strong background in biomedical research and significant experience in clinical trial monitoring. Candidates should thrive in a collaborative environment and possess excellent communication skills.

Benefits

Health and Wellness programs

Paid Leave

Retirement benefits

Qualifications

• Minimum two years of experience in biomedical research.
• Experience in clinical trial monitoring or site management.
• Ability to manage projects with large data volumes.

Responsibilities

• Monitors clinical trials for compliance with regulations and protocols.
• Verifies documentation for adverse events reporting.
• Coordinates site initiation and monitoring activities.

Skills

Clinical trials monitoring

FDA regulations

GCP guidelines

Data accuracy

Project management

Education

Bachelor’s degree in biomedical research or related field

Tools

MS Excel

Word

PowerPoint

Adobe Acrobat

Job description

Join to apply for the Clinical Research Associate II (CRA II) role at Frederick National Laboratory for Cancer Research

Join to apply for the Clinical Research Associate II (CRA II) role at Frederick National Laboratory for Cancer Research

Get AI-powered advice on this job and more exclusive features.

Job ID: req4300

Employee Type: exempt full-time

Division: Clinical Monitoring Research Program

Facility: Telework: US

Location: USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

Program Description

Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides regulatory, clinical trials management, protocol development/navigation and program management support to the office of the Clinical Director, National Institute of Mental Health (NIMH).

This position is 100% remote. Candidates must reside in the U.S.

Key Roles/Responsibilities

• Provides clinical trials monitoring for Phase I-III single site to large networks of clinical sites participating in Investigational New Drug (IND), Investigational Device Exemption (IDE), and non-IND/IDE protocols.
• Ensures sites are following U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) guidelines, and other applicable regulations.
• Verifies source documentation for the appropriate recording and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Critically evaluates clinical data for accuracy and completeness while ensuring the safety and confidentiality of participants according to the study monitoring plans.
• Provides monitoring of pharmacy records, including receipt, storage, labeling and final packaging, inventory, distribution, accountability and the processing and disposal of returned investigational agents according to the study monitoring plans, protocol and Standard Operating Procedures (SOPs).
• Maintains positive working relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs).
• Assists the clinical investigators and teams with establishing best practices to ensure adherence to all applicable guidelines, GCPs and SOPs.
• Reviews and offers input on protocol and Informed Consent Forms (ICFs).
• Coordinates and completes monitoring activities of clinical studies including conducting site initiation, monitoring and close-out visits, completing reports in a timely manner, ensuring the conduct of the trial is conducted in compliance with the approved protocol, SOPs, International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), Institutional Review Board (IRB) and NIH policies, and applicable regulatory requirements.
• Assists other CRAs and Project Managers in the continued development of team processes, procedural documents and study-related documents.
• Assists with ensuring required approvals are in place to initiate intramural research.
• Reviews or helps create internal and/or external SOPs, guidelines, and tools.
• Travels to domestic and possible international clinical sites as assigned.
• Oversees the maintenance of the Essential Study Documents ensuring all required essential study documents are current, complete, and accurate.
  
  

Basic Qualifications

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor’s degree from an accredited college/university in a field related to biomedical research, clinical trials and/or health or four (4) years related experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of two (2) years of progressively responsible experience in biomedical research.
• Previous clinical trials monitoring or site management experience.
• General knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and GCPs.
• Knowledge of Clinical Trials Management Systems.
• Extensive experience using various software applications such as MS Excel, Word, PowerPoint, and Adobe Acrobat; relational databases structures and reporting software.
• Ability to manage projects involving large volumes of data.
• Ability to work in a clinical research setting, both independently and within a team.
• Ability to prioritize multiple tasks/projects and accomplish goals in expected timelines.
• Ability to communicate effectively, verbally and in writing, with non-technical and technical staff.
• Ability to obtain and maintain a security clearance.
  
  

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• Mental health experience.
• Knowledge of Department of Health and Human Service (DHHS) regulations.
• Experience with the development of Case report form design, manual of operations and study monitoring plans.
• Knowledge of conducting federally funded studies.
• ACRP Certified CRA or SOCRA Certified Clinical Research Professional.
• Strong communication and presentation skills.
  
  

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay And Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

74,800.00 - 128,625.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

Referrals increase your chances of interviewing at Frederick National Laboratory for Cancer Research by 2x

Sign in to set job alerts for “Clinical Research Associate” roles.

e-Service Chat Representative - 100% Remote

Mobile Research Unit Clinical Study Coordinator (Contract)

Baltimore, MD $50,000.00-$65,000.00 7 hours ago

Intake Patient Care Representative (REMOTE)

Work from home - Teach English Online with YiYi English

Research Associate II - Patient Centered Research

Clinical Research Associate (CRA) - Medical Device/Toxicology Products

Clinical Trial Coordinator- FSP- Germany

Mobile Research Unit Clinical Study Coordinator (Contract)

College Park, MD $50,000.00-$65,000.00 7 hours ago

United States $36,986.00-$60,492.00 2 hours ago

Health Information Specialist I (REMOTE)

Health Information Specialist I (REMOTE)

Mobile Research Unit Clinical Study Coordinator (Contract)

Towson, MD $50,000.00-$65,000.00 7 hours ago

Health Information Specialist I - Remote

Reston, VA $37,831.00-$64,313.00 2 hours ago

United States $65,000.00-$70,000.00 1 week ago

Health Information Specialist I (REMOTE)

e-Service Chat Representative - 100% Remote

Healthcare Terminology Standards Analyst (REMOTE)

Staff Clinical Evaluation Specialist (Remote)

United States $105,100.00-$172,300.00 2 hours ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.