Job Abstract

About GW MFA

MFA physicians provide comprehensive patient care, offering one practice for the whole person with 52 medical and surgical specialties. As members of the GW School of Medicine and Health Sciences faculty, MFA providers are teachers and mentors for medical students, residents, fellows, and researchers preserving the rich tradition of academics, research, and healing. In addition to maintaining a closely integrated alliance with The George Washington University and The George Washington University Hospital (GWUH) which is separately owned and operated by Universal Health Services (UHS), the GW MFA has active referring relationships with 12 area hospitals.

The GW MFA’s leading healthcare presence in the DC metro region is complemented by a network of community-based practices in DC, Maryland, and Virginia. Given its geographic location in central NW Washington, DC, and proximity to more than 175 resident embassies, the MFA continues to evolve its international clinical outreach.

Position Summary

The Research Associate supports research projects in an assigned Practice Area through the performance of basic clinical and administrative procedures including data collection and tracking. This position helps ensure that GWMFA research projects conform to regulatory and clinical guidelines. The Research Associate participates in assigned department research projects including regulatory and administrative functions associated with the clinical research program in the department. The current study is clinical research on treatment of opioid use disorder (OUD); the Research Associate must have comfort communicating empathetically and in a person-centered fashion with individuals with OUD, and comfort with the principles of harm reduction.

Essential Duties and Responsibilities to perform this job successfully, and individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.

The Research Associate performs the following duties/responsibilities for the assigned Practice Area:

1. Work with the PIs to maintain updated files on all on-going IRB studies and protocols including the correspondence of informed consent forms, marketing materials, and data collection forms.
2. Maintain secure files on all protected study related data.
3. Maintain and report on updated information on study progress and participate in recruitment, consent, follow-up and other study procedures.
4. Maintain a schedule of IRB related deadlines for annual study renewal and closure.
5. Maintain files on all presented and published study results.
6. Maintain updated documentation of all IRB required CITI training.
7. Facilitate additional research items including but not limited to study registration on clinicaltrials.gov and assistance with Investigational New Drug (IND) items.
8. Ensure compliance with research protocols and federal regulations.
9. Maintain and oversee implementation of Manual of Operations for clinical trials.
10. Screen and enroll research participants, obtaining informed consent, including a review of medication histories to see if subjects are eligible for enrollment, conduct interviews with subjects, and develop systems for high quality data collection. Act as liaison between participants, clinicians and other study team members.
11. Oversee tracking site enrollment, performance information, and subject study status including distributing and tracking study incentives. Establish methods to track follow and maintain subjects.
12. Oversee randomization process and quality control/quality assurance of study implementation and data collection.
13. Oversee study retention by developing systems with the study staff to maximize retention.
14. Coordinate study implementation with others, such as with physicians/clinicians, social workers, patient/peer navigators, technicians, and all other study team members.
15. Work with investigators on submitting study results at investigational meetings for publication.
16. Additional duties include assisting the PI with day-to-day affairs of the site activities as they relate to the study management of the Clinical Trial.

OTHER DUTIES

The Research Associate may also:

1. Perform other duties as needed to support the timely completion of research projects that are consistent with established protocols.
2. Participate in preparation of new research proposals.
3. Facilitate grant submissions and requests for funding.
4. Establish Data and Safety Monitoring Boards (if required).

Minimum Qualifications

The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education

Completion of MPH or related degree or have commensurate relevant work experience.

Experience

One to two years of experience in clinical research coordination preferred as well as applicants with previous clinical research background, particularly in medication treatment for opioid use disorder (OUD) or working with individuals with OUD.

Competencies The requirements listed below are representative of the knowledge, skills, and/or traits required for success in this position.

Research Associate must demonstrate:

• Knowledge and support of GWMFA’s vision, mission statement, values, and guiding principles.
• Knowledge of and ability to follow study research designs, protocols, and standard operating procedures.
• Previous experience with project coordination (desired).
• Familiarity with data collection tools and data management and analysis programs (desired).
• Excellent interpersonal skills for communicating professionally, cheerfully, and effectively with study participants, families, clinicians, social workers, patient/peer navigators and other study team members.
• History of working independently and as part of a team.
• Good written communication skills for the preparation of coherent research summaries.
• Proficiency reading documents and following instructions written in English.
• The ability to work well with others across differences and resolve conflicts when they occur.
• Familiarity with the technology/equipment utilized by the research project.
• Compassion, patience, and calm.
• Integrity, with appropriate concern for confidentiality.
• Flexibility, initiative, and self-direction.
• Attention to detail and ability to manage multiple priorities.
• Concern for quality and accuracy.

Other Requirements

None at this time

Supervision Received

PGA/Department Manager and Senior Director of Clinical Research Operations. Direct collaboration with Physician Fellowship / Research Liaisons.

Supervision Exercised

Supervision over data entry or support staff for research.

Physical Requirements

• Sit, walk, reach, bend, or twist for long periods of time in a clinical setting.
• Must be able to lift, carry, push, or pull up to 100 lbs. as part of the role.
• Regularly exposed to healthcare settings that may require personal protective equipment.
• Requires manual dexterity to operate a computer keyboard, calculator, copier machine, and other equipment.