Bachelor's degree in allied health or related field, or equivalent experience
3-4 years of clinical research or related experience
Proven experience as a clinical research coordinator
Demonstrated aptitude for research facilitation
Strong verbal and written communication skills
Excellent organizational skills
Proficient in computer skills
Responsibilities
Oversee compliance with regulatory requirements and Good Clinical Practice (GCP)
Prepare and maintain regulatory documents and audit-ready documentation
Coordinate informed consent, participant education, and study visits
Monitor and report adverse events and safety concerns
Ensure accurate clinical data entry and maintenance of research databases
Manage biospecimen collection and investigational product accountability
Support study budgets and compliance with research-related costs
Coordinate training, sponsor communications, and site monitoring visits
Prepare for internal and external audits and inspections
Collaborate with investigators and multidisciplinary teams to resolve study issues
Benefits
Opportunity to work on high-profile research projects
Independence in coordinating complex clinical studies
Support for professional development and training
Engagement with multidisciplinary teams
Involvement in regulatory compliance and quality improvement initiatives
Full Job Description
General Summary of Position Under the guidance of the Clinical Trial Manager the Clinical Research Coordinator (CRC) III functions independently and proficiently with minimal oversight and is responsible for the complete coordination of assigned clinical research activities of all phases and all levels of complexity including investigator-initiated or other high profile research. Demonstrates competence in clinical research skills problem solving priority setting and supports less experienced staff. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.
Primary Duties and Responsibilities
Oversee clinical research studies to ensure compliance with regulatory requirements, Good Clinical Practice (GCP), institutional policies, and sponsor protocols.
Prepare, submit, and maintain regulatory documents, study records, delegation logs, and audit-ready documentation.
Coordinate informed consent, participant education, recruitment, retention, and study visits while prioritizing participant safety and rights.
Monitor and report adverse events, protocol deviations, and safety concerns; escalate issues to investigators as appropriate.
Ensure accurate and timely clinical data entry, validation, query resolution, and maintenance of electronic research databases.
Coordinate biospecimen collection, processing, storage, and transport in accordance with study protocols and safety requirements.
Manage investigational product accountability, participant randomization, and study supplies in accordance with sponsor and regulatory requirements.
Support study budgets, contracts, billing compliance, and appropriate allocation of research-related costs.
Coordinate study team training, sponsor communications, investigator meetings, site monitoring visits, and multisite research activities.
Prepare for and support internal and external audits, FDA inspections, and study initiation, monitoring, and closeout activities.
Collaborate with investigators, sponsors, and multidisciplinary teams to resolve study issues, improve research quality, and support departmental goals.
Maintain required research training and current knowledge of applicable regulations, ethical standards, and clinical research practices.
Minimal Qualifications Education
Bachelor's degree, or allied health or related degree required, or equivalent work experience required
Experience
Experience as a clinical research coordinator in the clinical research field required
3-4 years Clinical research or related experience required
Research and/or work experiences that demonstrate aptitude for research facilitation required
Knowledge Skills and Abilities
Excellent verbal and written communication skills.
Strong communication and organizational skills.
Proficient computer skills.
This position has a hiring range of
USD $65,062.00 - USD $117,291.00 /Yr.
About MedStar Southern Maryland Hospital Center
MedStar Southern Maryland Hospital Center is a medical facility located in Clinton, Maryland. It is a 192-bed acute care hospital that provides a range of services including emergency care, cardiology, cancer care, orthopedics, and women's health. The hospital is part of the MedStar Health system, which is the largest healthcare provider in Maryland and the Washington, D.C. region. MedStar Southern Maryland Hospital Center is committed to providing high-quality, compassionate care to its patients and improving the health of the communities it serves.
