Nature and Scope of Position:
Implements and coordinates cardiovascular clinical trials conducted by MedStar Health Research Institute and/or its affiliated institutions in compliance with GCP, ICH, FDA and institutional regulations. Must be a good communicator, detailed oriented and able to use critical thinking skills to manage multiple and competing priorities in a timely fashion.
Principal Duties and Responsibilities:
Coordinates clinical trial activities an appropriate manner according to the protocol, GCP, ICH, FDA and compliance guidelines. This includes but is not limited to recruitment, screening, enrollment, and follow-up of eligible subjects.
Maintains efficient organizational management of the trial, including but not limited to timeliness in scheduling and completing study visits; completing Case Report Forms (CRFs); addressing queries and/or data clarification forms; Responsive and prepared during monitoring visits.
Monitors, records and submits adverse events, endpoints, patient safety reports, and protocol deviations in a timely manner to the appropriate parties.
Manages resources and priorities of multiple trials, in multiple phases of development effectively; Monitors inventory levels and anticipates study needs.
Maintains accurate and complete regulatory files, including but not limited to study specific regulatory documents, fully executed informed consent forms, relevant IRB approvals, source documentation, IP dispensing logs (drug and/or device), subject logs, study-related communications, temperature logs, inventory control and quality control logs, certifications and training logs.
Acts as a liaison between sponsor, site, regulatory personnel, management, and staff. Effectively communicates all protocol-related issues/problems to the appropriate personnel including but not limited to questions regarding the conduct of the clinical trial, issues of subject eligibility, enrollment, compliance, and retention, .adverse events, and deviations,
Maintains research compliancy at the site, including the Maryland State Laboratory compliance program, FDA and sponsor audits, CMS approvals, billing compliance, integrity agreements, conflict of interest statements, and institutional and protocol related training requirements.
Ensures timely reporting of all subject visits into IntelliTrial, as well as the processing of subject stipends.
Acts as a representative of the research team for procuring new business. Assists in the completion of feasibility questionnaires and attends site qualification visits as required. Maintain confidentiality regarding patient care, research clients and business strategies.
Assists with quality assurance initiatives, including the training and mentoring new research team recruits.
Assists research department in special projects or with staffing coverage.
Participates in conferences, departmental meetings, continuing education, investigator meetings, site initiation, interim monitoring and closeout study visits as assigned.
Seeks opportunities to develop knowledge in clinical research.
Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner
Performs other duties as assigned.
- Minimum of five (5) years experience in the specialty or a related area required, with at least three (3) years of clinical research experience.
- Possess a working knowledge of theory and practice in the specialty area and clinical research field.
- Certification as a research professional preferred (ACRP, SOCRA).
- Possess excellent oral and written communication skills.
- Must be flexible, pro-active and able to use critical thinking skills to manage multiple and competing priorities in a timely fashion.
- Must have excellent attention to detail, and work independently under limited supervision.
- Ability to perform clinical tasks required by the protocol (ECG, phlebotomy, vital signs, etc.)
- Ability to operate standard office equipment;
- Computer proficiency required for entering data into databases, managing emails and electronic documents.
- Ability to travel to study meetings as required.
Training and Certification:
BCLS certification desired.
Must maintain current state licensure for duration of employment.
Collaborative Institutional Training Initiative (CITI) and Good Clinical Practices (GCP), and Occupational Safety and Health Administration (OSHA) training required.
Additional training as per job requirements (ie. International Air Transport Association (IATA) for dangerous goods).
The duties reflected in this description do not preclude the assignment of other duties and responsibilities. They provide a general summary of the work required, and should not be treated as a total and complete list of expected duties to be performed by employees in the classification. Minimum qualifications, duties and responsibilities may be modified at the discretion of management.