Clinical Research Coordinator

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.
Job Summary:
MAPMG is seeking a Clinical Research Coordinator to participate throughout the entire clinical trials study process. Specific responsibilities include preparing and submitting IRB and regulatory documents, collaborating with physicians 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. Some travel is required (investigator meetings/training and to Kaiser Permanente medical centers within the region). Applicants must be local or willing to relocate to the DC, Maryland, or Virginia area.
This position is an on-site position that will be based out of the Kaiser Permanente Gatihersburg Medical Center.
Job Responsibilities:

• Recruit and evaluate clinical study subjects, scheduling appointments and interviews
• Provide instruction to potential clinical study subjects and those involved in care of subjects on aspects of subject's care, treatments, and side-effects
• Explain informed consent procedures and obtain written consent
• Explain subjects on diagnosis and treatment plan, where appropriate
• Facilitate test and procedure scheduling for subjects participating in clinical trials and/or treatment plans according to protocol design
• 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
• 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
• Complete, submit, and maintain documentation required by Office of Human Research Protection and regulatory documentation required by Sponsor
• Adhere to protocol requirements; identify and implement strategies to prevent protocol deviations and violations
• Follow billing policies and procedure to assure proper billing for research- related services
• Coordinate and participate in monitor and regulatory visits, and manage timely responses to queries (e.g., corrective action plans)
• 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
• 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
• Prepare IRB documentation as required, including: initial submissions, protocol amendments, protocol modifications, Adverse Event Reports, protocol deviations, protocol violations, continuing review, and informed consent documents
• Obtain and prepare regulatory documents required to conduct clinical trials, including: investigator CVs, financial disclosure forms, laboratory certifications, radiation safety exemptions, FDA 1572 forms, etc

Education/License/Certification

• 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.

Qualifications

• Minimum of three years of Clinical Research experience.
• Minimum one year of related work experience in clinical trials research.
• Detailed knowledge of research rules and regulations and Good Clinical Practice (GCP) guidelines.
• Proficient with word processing and spreadsheet applications, and other software applications unique to the MAPRI.
• Strong project management and organizational skills.
• Strong written and oral communication skills.
• 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:
We are proud to offer a comprehensive benefits package that is designed to support our employees and their families' health and wellbeing. We offer competitive compensation and benefits designed to help our employees stay healthy and thrive in and beyond the workplace.

• Competitive compensation package
• 100% employer-funded medical and dental insurance premiums for employees and families
• Great work/life balance
• Generous paid time off, including vacation, holidays, and sick leave
• Maternity and parental leave
• Pension plan, and 401(k) retirement plan with employer contributions
• Life insurance, and short-term disability and long-term disability coverage
• Education reimbursement
• Wellness programs and resources to help you maintain a healthy lifestyle
• Employee Assistance Program

Equity, Inclusion, and Diversity:
At MAPMG, equity, inclusion, and diversity are at the core of our organizational culture. MAPMG is proud to be an equal opportunity employer and is committed to providing equal opportunity for all employees and applicants. We continuously work 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 to apply.
External hires must pass a background check and drug screening.
We are proud to be an equal opportunity/affirmative action employer.
We value our diversity and E/O/E M/F/D/V.