Clinical Research Coordinator - Surgical Services Research Adm

Washington, District of Columbia-Washington
Oct 22, 2020
Oct 28, 2020
Analyst, Research
Full Time
This position requires prior clinical research experience. The individual will be responsible for the overall coordination of project activities and perform a variety of research, data base and clerical duties of a routine and technical nature in support of clinical trials in an effort to assist investigators in organizing, gathering and compiling clinical research data. This person is primarily responsible for data collection through patient enrollment, patient or family interviews, medical chart abstraction or other methods. The CRC II will also form other duties such as data entry in addition to being responsible for selected administrative duties such as filing and record keeping, photocopying, creating flyers and posters and maintaining study records. The individual will submit and maintain ongoing regulatory documents including the preparation of IRB applications and adverse event reporting and ensures protocol compliance. The position may support multiple investigators or studies. The CRC II may assume responsibility for directing the work of Clinical Research Assistants (CRC) or Clinical Research Coordinator I (CRC I). The Clinical Research Coordinator II requires limited supervision and works largely independently. The individual is supervised by a senior research staff member or principal investigator.


Minimum Education

Specific Requirements and Preferences
Bachelor's in science, technical, or health-related field with 3-5 year relevant experience. MS degree with 1-3 years relevant experience preferred/desired. (Required)

Minimum Work Experience
1 year

Specific Requirements and Preferences
At least 1-4 years of clinical and/or research experience or an equivalent combination of relevant education and/or experience. Prior clinical research experience preferred/desired. (Required)

Functional Accountabilities

Responsible Conduct of Research
1. Consistently demonstrate adherence with the standards for the responsible conduct of research.
2. Plan, conduct, and manage research projects within the federal and institutional regulations and policies under the direction of the principal investigator.
3. Responsible for appropriate use of research funds and resources.
4. Comply with all annual job-related training requirements.

Regulatory Documents
1. Maintain regulatory documents as per sponsor and data center instructions.
2. Ensure regulatory integrity of protocols through preparation and submission of the protocol, consent forms, protocol amendments, and annual progress/continuing reviews to the IRB for approval in accordance with regulatory and/or IRB guidelines and in compliance with the sponsor's specific timeline.
3. Prepare for sponsor audits.

Study Conduct and Data Collection
1. Work with the Investigator to prepare all study start-up documents and submit them to the sponsor, when appropriate.
2. Assist in writing consents and interact with the IRB and/or sponsor regarding wording issues and approvals.
3. Recruit and schedule study subjects.
4. Ensure that all signatures and dates are on consent forms.
5. Document, distribute and file consent forms appropriately.
6. Register each study visit appropriately.
7. Assist the investigator with study visits and subject payment (where applicable).
8. Review source documentation, interprets data and records results.
9. Accurately and in a timely manner collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation as directed.
1. Correctly enter any clinical and research data and information into.
1. Track data expectancy to meet sponsor's deadlines.
1. Create/review source documents and set up study files in an organized fashion.
1. Ensure that all the necessary data are gathered and recorded in the appropriate source documents, case report forms, and electronic data capture systems; review case report form entries for completeness, correctness and logical sense; and manage data queries in a timely manner.
1. Work with sponsor monitors (CRAs).

Specimen Collection
1. Plan and coordinate research specimen collections, including sample and data collection.
2. Coordinate biologic/pharmacokinetic study requirements in a timely and efficient manner.
3. Maintain certification for shipping specimens if applicable.

Other Responsibilities
1. Maintain regular communications with sponsors and/or CROs, IRBs, and the institution.
2. Collaborate with other departments (laboratory, research pharmacy, etc.) as necessary.
3. Identify and resolve issues and challenges.
4. Coordinate sponsor and/or regulatory audits.
5. Serve as an effective liaison between the Investigators, sponsors, hospital departments involved with research studies, and the Clinical Research Center.
6. May direct the work of CRA or CRC I.

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification
1. Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication 1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others' ideas and opinions
Performance Improvement/Problem-solving 1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility 1. Use resources efficiently
2. Search for less costly ways of doing things
Safety 1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Children's National Health System is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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