Clinical Research Coordinator - McLean, United States - MAPMG

MAPMG McLean, United States

6 days ago

Description

Who We Are:

At the Mid-Atlantic Permanente Medical Group, more than 1,700 Permanente physicians and nearly 300 staff professionals come together to make a positive impact on the health and lives of more than 825,000 people who get their healthcare through Kaiser Permanente. Serving a diverse community that spans Washington, D.C., suburban Maryland, Baltimore, and northern Virginia, we are a single group practice that offers an array of best-in-class facilities, resources, and services at over 30 medical centers, more than a dozen community hospitals, and several skilled nursing facilities - all focused on creating an environment that empowers our physicians to provide high-quality care.

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 Tysons Corner Medical Center in Tysons Corner, Virginia.

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 (3) 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.

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