Research Assistant (Clinical Trials)
Mid-Atlantic Permanente Medical Group

Job Info

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Who We Are:

The Mid-Atlantic Permanente Medical Group, (MAPMG) is one of the nation's premier multispecialty medical groups and is the largest integrated medical group in Maryland, Virginia and the District of Columbia. Founded in 1980, the medical group has more than 1,700 Permanente physicians spanning more than 50 subspecialties. Together, we serve approximately 800,000 Kaiser Permanente members in Maryland, Virginia, and the District of Columbia at 34 area medical centers, plus several community hospitals and skilled nursing facilities.

Overview:

MAPMG is seeking a Research Assistant (RA) to participate throughout the entire clinical trials study process. The RA supports the clinical trials team, specifically assisting with regulatory documents as needed, assisting the research and Principle Investigator (PI) team to determine patient eligibility for clinical trials, discussing specific trials with potentially eligible patients, consenting and coordinating patients to be enrolled in specific clinical trials, and monitoring patients enrolled in clinical trials.

Additional responsibilities include assisting with the development, implementation, and evaluation of clinical trials for research by pharmaceutical companies, device manufacturers, collaborating institutions, cooperative groups, and internal investigator-initiated studies. Some travel is required (investigator meetings/training and to Kaiser Permanente medical centers within the region).

Responsibilities:

• Complete all source documentation and Case Report Form, maintain thorough and organized study documentation, including research records, phone logs, screening logs, and regulatory binders, and accurate drug accountability records.
• Adhere to protocol requirements; identify and implement strategies to prevent protocol deviations and violations.
• Monitor subject responses to protocol and communicate findings to the physician and health care team; report adverse events to the PI and others as required by protocol.
• Coordinate and participate in monitor and regulatory visits, and manage timely responses to queries (e.g., corrective action plans).
• Explain informed consent procedures and obtain written consent.
• Facilitate test and procedure scheduling for subjects participating in clinical trials and/or treatment plans according to protocol design.
• Assist CRCs and CRNs to recruit and evaluate clinical study subjects, scheduling appointments and interviews.
• Perform essential subject assessment functions such as accurately obtaining vital signs and collecting biological specimens.
• Perform procedures according to the protocol using proper technique, standard precautions, and following Good Clinical Practice guidelines.
• Attend research and clinical staff meetings, conferences, and in-service education of nursing and medical staff.
• Foster and maintain cooperative relationships with other departments, patients, medical staff, and sponsors.
• Responsible for knowing and following all MAPRI SOPs, IRB SOPs, Kaiser Permanente policies and procedures, and Federal rules and regulations applicable to clinical research.

Qualifications:

• Bachelor’s degree in Healthcare/Science or Clinical Research related field preferred.
• Research professional certification within 2 years of hire (e.g., Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).
• DOT/IATA certification within one year of hire.
• Ability to travel to multiple locations within the Mid-Atlantic area (including Washington DC, Maryland, and Northern Virginia).
• Ability to communicate clearly and effectively.
• Ability to work independently.
• Ability to maintain confidentiality.
• Knowledge and proficiency of PC and Mac, Microsoft Word, Microsoft Excel (basic data entry) and iPad applications.
• Ability to work with minimal supervision and in self-directed manner.
• Ability to maintain meticulous records for clinical trials and research projects, including case report forms, regulatory documents, correspondence, etc.
• Ability to interact on a scientific level with medical staff, physicians, and representatives of national and pharmaceutical groups.
• Ability to collaboratively assure protocol compliance and completion.

Competitive Benefits:

• Competitive compensation package
• Comprehensive benefits including 100% employer-funded medical and dental insurance premiums for employees and families
• Great work/life balance
• Generous paid time off
• Maternity and parental leave
• Pension plan and 401(k) retirement plan
• Life insurance, and short-term disability and long-term disability coverage
• Education reimbursement

Equity, Inclusion, and Diversity:

MAPMG continuously works to identify and mitigate healthcare inequities, and that starts with providing an inclusive, supportive environment for our employees. We encourage applicants of any race, color, religion, sex, sexual orientation, gender identity, or national origin who value diversity and will commit to practicing culturally competent healthcare.

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