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Company: MedStar Medical Group

Location: Washington, DC

Career Level: Entry Level

Industries: Not specified

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Description

General Summary of Position
Primary location for this position is Washington, DC but 2-3 days of travel may be required per week depending on the need for coverage at the satellite sites. Other sites include Fairfax VA, Reston VA, Clinton MD and Frederick MD. Candidates must have reliable transportation available.

Implements and coordinates research and administrative procedures for the successful management of clinical trials. Performs diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. Enters study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.

We are unable to offer visa sponsorship for this position. Applicants must be authorized to work in the United States on a full-time, permanent basis without the need for current or future sponsorship.

Primary Duties and Responsibilities

Oversees, prepares, submits and maintains all regulatory submissions (e.g., new studies, annual review, amendments) accurately and within a timely manner; periodically self-audits records to ensure audit-readiness; ensures the appropriate delegation of study related tasks (i.e., Delegation of Authority).

Possesses basic understanding of clinical trial endpoints and analytical ability sufficient to evaluate data.

Oversees the informed consent process and reviews consent form with research participants and provides time for research participant to consider study participation; executes the informed consent process according to Good Clinical Practices (GCPs), procedures and other applicable rules, regulations and policies; educates new staff and research participates about protocol expectations and the conduct of clinical trials.

Attends investigator meetings as required or as requested by the investigator and assists the investigator in communication of study requirements to all individuals involved in the study and provides appropriate training for study teams members; documents date of training and signatures of study personnel trained on study specific training log as appropriate; alerts the investigator when the research participant's safety is in jeopardy, there is a protocol deviation, or when the research participant request premature study termination.

Randomizes research participants using an interactive voice response system or other system as applicable and maintains all test article records as required by regulatory agencies and sponsor's requirements; prepares emergency use or expanded access reports as applicable.

Optimizes the safety of research participants by monitoring and reporting any non-serious or serious adverse events to the investigators and other members of the study team; presents investigator with relevant information for determination of seriousness, causality and intervention; assists investigator (as appropriate) in classifying adverse events (e.g., serious, moderate, unexpected); acts on investigator's recommendation for adverse event intervention (e.g., stop test article, call research participant, re-test, treat); maintains follow-up to determine resolution of adverse event.

Collaborates with the investigator and administrative leadership to prepare a categorized budget and justification; confirms the accuracy and completeness of budgeted costs; reviews and develops familiarity with the executed contract to ensure that the study is in compliance with all terms and conditions, health and safety precautions for research participants and any financial terms and conditions.

Understands and complies with rules for billing Medicare, Medicaid and third party payors for services, drugs, devices, tests and procedures rendered in the clinical research context; oversees and ensure registration of each research participant according to the billing matrix/billing plan and ensures billing of study procedures and/or visits to the appropriate funding source.

Oversees the return or dispose of unused supplies per sponsor requirement; reconciles test article accountability; documents research participants who are lost to follow-up or who have dropped out (e.g., causes, contact efforts); assists in the preparation for a potential routine pre-market approval (PMA) FDA inspection as applicable.

Supports an investigator-initiated IND or IDE study; prepares for internal or external audits and/or FDA inspections; assists and facilitates research and/or project team meetings; coordinates multi-center studies as applicable; acts as a liaison for research participants, investigators, sponsors and healthcare professionals and compose clear, precise and detailed correspondence; schedules and leads site qualification, study initiation, monitoring and close-out visits;

Ensures that all key personnel engaged in the research project have met training requirements in accordance with Federal regulations, institution and sponsor policies and procedures; maintains effective and ongoing communication with sponsor, multidisciplinary, ancillary and inter-professional research teams; understands and contributes to scientific center goals and growth and maintains knowledge in the field through attending related project meetings, reading related literature and maintains professional associations as appropriate.

CUSTOM.PRIMARY.DUTIES.RESPONSIBILITIES.ADDENDUM

Minimum Qualifications
Education

Bachelor's degree or an allied health or related professional 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 $63,793 - $113,318

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Clinical Research Coordinator III - Cardiology Job Listing at MedStar Medical Group in Washington, DC (Job ID req47754)

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Clinical Research Coordinator III - Cardiology Job Listing at MedStar Medical Group in Washington, DC (Job ID req47754)

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