Clinical Research Assistant

ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES PC•Rockville, MD

About The Position

The Clinical Research Assistant supports the conduct of clinical trials by providing information about active protocols and disease indications, recruiting and enrolling eligible participants, and assisting patients throughout their study participation. The role reviews medical records and schedules, verifies eligibility with research staff, discusses informed consent, documents adverse events, and helps arrange appointments and follow-up testing. The assistant maintains accurate clinical trial management system records and study documentation, including visit and stipend tracking, data entry, query resolution, case report forms, regulatory records, laboratory results, receipts, invoices, and calibration reports. The role also handles protocol-related administrative tasks such as processing and shipping laboratory samples, managing study supplies, scheduling visits, and performing vitals, patient-reported outcome (PRO) administrations, and phlebotomy. The position monitors adherence to study protocols, identifies compliance problems, and works with the research nurse and principal investigator to address them. It requires professional service to patients and staff, confidentiality, an organized office, and travel as necessary for investigator meetings and other AARR sites.

Requirements

Associate degree or equivalent.
In-depth knowledge of medical procedures and clinical terminology.
Strong organizational skills.
Ability to develop and maintain strong professional relationships with providers and research subjects.
Ability to maintain confidentiality of patient and study information.
Excellent verbal and written communication skills.
Ability to lift 20 pounds.
Willingness and ability to travel for investigator meetings and other AARR sites.
Ability to assess patient eligibility using protocols and medical records and verify information with a clinical research nurse and/or principal investigator.

Nice To Haves

Bachelor’s degree in biological sciences, health sciences, or an allied medical profession, or an equivalent combination of education and experience.
Clinical research experience.
Experience performing phlebotomy.
Experience performing basic laboratory procedures to process biological specimens.

Responsibilities

Maintain knowledge of active protocols and disease indications and provide information about them to staff and patients.
Assist with recruitment through chart and schedule reviews, contacting recruitment leads, following up on referrals, and other recruitment activities, potentially including breakfasts, advertising, health fairs, and community outreach.
Assess potential participants’ eligibility, recruit and enroll patients according to study protocols, and verify eligibility criteria using medical records and research staff.
Discuss informed consent with patients, document adverse events, interact with patients throughout treatment, and assist with appointments and follow-up tests.
Keep the clinical trial management system current, including recruited subjects, completed visits, participant and investigator stipends, and patient status.
Process and ship laboratory samples to central and local laboratories.
Perform data entry, resolve queries, and extract patient data from hospital, outpatient, and private physician records for case report forms.
Track study supply inventory and reorder supplies as needed; maintain office supply inventory and an organized office space.
Schedule patient visits in appropriate electronic systems.
Maintain and file subject, regulatory, laboratory, receipt, invoice, and calibration documentation.
Perform vitals, patient-reported outcome administrations, and phlebotomy.
Monitor adherence to protocols by physicians, nurses, fellows, and patients; review requirements with clinical staff and work with the research nurse and principal investigator to correct compliance problems.
Follow established policies, procedures, regulatory and accreditation requirements, and professional standards.
Provide professional service to employees and research subjects and maintain confidentiality of patient and study information.
Travel as necessary for investigator meetings and other AARR sites.