Full time Clinical Research Coordinator needed for our dermatology office in both our DC and Annapolis Office.
We are looking for someone to start immediately. Candidate must be able to commit for a minimum of 2 years.
We are looking for a reliable, professional, responsible, independent, enthusiastic have great communication skills and be a team player. The right applicant must be self-motivated, a quick learner and able to handle multiple tasks at once. The CRM ensures that clinical trials and studies are run according to protocol. Clinical Research Manager work closely with the research team in the day-to-day research activities and in the conduction of study visits and data management.
The Clinical Research Coordinator is responsible for promotion of good clinical practices and medical care in the conduct of clinical investigation. This will be performed by ensuring adherence to protocol requirements, assuring the integrity of data generated at the site, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents. By the very nature of the profession, the level of assignment will call for a maximum degree of knowledge, professional judgment, and ingenuity.
MAJOR DUTIES/ESSENTIAL FUNCTIONS
Essential and other important responsibilities and duties may include, but are not limited to the following:
A. ENSURES PROTOCOL COMPLIANCE:
- Possesses a thorough understanding of the requirements of each approved protocol in the research portfolio under their direction.
- Determines that inclusion/exclusion criteria are applicable to the study population.
- Implements any protocol deviation or changes only with PI’s agreement.
- Reviews the inclusion/exclusion criteria, schedule of visits, end point criteria, and investigational article use with the research team.
B. MANAGES THE MEDICAL CARE OF SUBJECTS:
- Ensures qualified personnel (PI or sub-investigator) are informed of all trial-related medical decisions.
- Evaluates for adverse experiences.
- Ensures that medical care is provided to a subject for any adverse event(s) under the direction of the PI.
- Documents in the medical record the subject's participation in the trial.
C. PROTECTS THE RIGHTS AND WELFARE OF SUBJECTS:
- Reports all serious adverse events immediately to the PI.
- Obtains a signed and dated informed consent from the subject or subject's legal representative prior to initiating any study-related procedures.
D. ENSURES VALIDITY OF THE DATA REPORTED:
- Ensures the accuracy, completeness, legibility, and timeliness of case report forms and source documents.
- Ensures that case report forms accurately reflect source documents.
- Explains any discrepancies between source documents and case report forms.
- Endorses changes or corrections to a case report form.
- Communicates effectively with PI.
- Meets regularly with the PI and research coordinator to discuss subject participation and protocol progress.
- Participates in monitoring visits and audits as appropriate.
- Permits monitoring and auditing by the sponsor and appropriate regulatory authorities.
MINIMUM QUALIFICATIONS
- Bachelor’s degree required.
- Three plus years of experience preferred.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- An understanding of research processes and methodologies.
- Ability to provide the PI with credentials as requested.
- Ability to prioritize and work independently.
- Ability to manage time effectively and organize own work.
- Ability to record and check data to ensure accuracy.
- Willingness to seek help, advice, and support as required.
- Willingness to work as part of a research team.
- Willingness to undergo training as required by the position.
- Understanding of the need for confidentiality in dealing with information.
- Ability to disclose conflicts of interest as described in the regulations.
- Excellent verbal and written communication skills.
- Ability to manage day to day work independently.
- Demonstrated ability to effectively work and communicate with diverse populations.
- Detail-oriented.
- Strong data management skills.
- Demonstrated proficiency with business software (e.g. Microsoft Office Suite).
Job Type: Full-time
Pay: $55,000.00 - $72,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee discount
- Health insurance
- Paid time off
- Vision insurance
Medical Specialty:
Schedule:
- 8 hour shift
- Monday to Friday
Education:
Experience:
- Management: 3 years (Required)
- Clinical research: 3 years (Required)
- Contract negotiation: 1 year (Required)
Willingness to travel:
Work Location: In person
