Clinical Research Coordinator - National Harbor, MD

Advanced Dermatology and Cosmetic Surgery•Oxon Hill, MD

About The Position

The Clinical Research Coordinator (CRC) is a specialized research professional who works with and under the supervision of the clinical Principal Investigator (PI) and reports directly to the Director of Clinical Research. The CRC supports, facilitates, and coordinates daily clinical trial activities and helps the PI, department, sponsor, and institution administer compliance, financial, personnel, and other aspects of clinical studies. The role coordinates study activities in accordance with federal regulations and sponsor policies, supports feasibility assessments and regulatory submissions, prepares study materials and files, and helps train study team members. The CRC supports recruitment and informed consent, screens and schedules participants, coordinates study procedures and specimen handling, collects study data, manages case report forms and study timelines, and maintains study supplies and investigational material accountability. The CRC also communicates with sponsors, participants, and the PI, supports study closeout, and arranges secure retention of study documents. Work is performed in offices and occasionally at research sites, with frequent telephone and in-person contact with staff, vendors, providers, and management. The position requires some flexibility in working hours, occasional weekend work, and occasional travel. The work can be demanding and requires effective conflict resolution.

Requirements

Ability to apply applicable government regulations, standards, and organizational quality assurance policies in performing job duties.
Knowledge of electronic health record access privileges and responsibilities and ability to perform job duties within assigned access levels.
Ability to maintain confidentiality and follow HIPAA regulations when handling patient information.
Ability to practice professional ethics and use discretion regarding organizational directives and proprietary information or trade secrets.
Ability to identify problems and resolve them effectively, seeking guidance from providers or management when necessary.
Knowledge of medical terminology and ability to use it appropriately.
Ability to manage time, prioritize, multitask, and adapt to change.
Ability to maintain a high level of accuracy in documentation and job duties.
Ability to perform essential duties within the scope of education and training.
Typing and keyboarding skills and computer proficiency.
Ability to read and interpret work-related documents, write routine reports and correspondence, and communicate effectively with patients and coworkers.
Professional telephone etiquette and communication skills.
Ability to perform basic arithmetic with whole numbers, fractions, and decimals.
Ability to understand and follow written and verbal instructions and manage problems involving several variables.
Strong problem identification and resolution skills.
Ability to work effectively in a demanding environment and resolve conflicts.
Occasional weekend work and travel are required; some flexibility in working hours is required.

Nice To Haves

Bachelor's degree in a related field preferred but not required.
Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) certification from SoCRA or ACRP preferred.
Phlebotomy certification preferred.
Good Clinical Practice (GCP) preferred.
International Air Transport Association (IATA) training preferred.

Responsibilities

Coordinate with the Principal Investigator, department, and administration to support compliance with federal regulations and sponsor policies and procedures.
Assist the PI with study feasibility assessments and review and understand study protocols.
Attend investigator meetings as required or requested by the PI.
Collaborate with the PI on IRB and other regulatory submissions and prepare study materials, including informed consent documents, source documents, enrollment logs, and accountability and temperature logs.
Establish and organize regulatory binders, source documentation, and other study files.
Communicate study requirements to study team members and provide appropriate training and tools; document training dates and signatures.
Collect documents required to initiate studies and submit them to sponsors.
Work with the PI to develop and implement recruitment strategies consistent with IRB requirements and approvals.
Conduct or participate in informed consent, interact with the IRB and research participants, answer study-related questions, and ensure forms are appropriately signed and dated.
Develop recruitment advertising and informational materials; identify and contact potential participants, schedule study visits, maintain enrollment logs, and send logs to sponsors or CROs.
Screen participants against protocol-specific eligibility criteria and document eligibility or exclusion.
Coordinate participant tests and procedures; draw blood or collect urine, prepare specimens for shipment, and collect protocol-required data and assessments, such as vital signs, questionnaires, EKGs, and photographs.
Ensure timely completion of Case Report Forms and maintain study timelines and adequate study supply inventory.
Follow sponsor protocols for investigational drug or device accountability and dispense study drugs to participants when applicable.
Complete study documentation and maintain study files according to sponsor requirements, including consent forms, source documentation, case report forms, notes to file, and investigational material accountability forms.
Track participant enrollment and document dropouts, reasons for withdrawal, and contact efforts.
Retain study records in the regulatory binder according to sponsor requirements and arrange secure document storage for the required retention period.
Maintain effective ongoing communication with sponsors, research participants, and the PI.
Assist the PI with accurate and timely study closeout submissions to applicable federal agencies and sponsors.
Follow confidentiality, HIPAA, ethical, and organizational policies; maintain accuracy, professionalism, teamwork, attendance, and punctuality; and enhance skills through continuing education.