Clinical Research Coordinator I

Talentify; Gaithersburg (MD); On-site; USD 37,000 - 47,000; Full time

Benefits offered by this job

Health Insurance

Dental

Vision

Long-Term Disability

Short-Term Disability

Life Insurance

401k

Job summary

CenExel Clinical Research is seeking a Clinical Trials Coordinator to assist in coordinating studies in accordance with ICH, GCP, and company guidelines. The role involves data collection, coordination from initiation to completion, and collaboration with sponsors and site staff.

Qualified candidates have 0-3 years in the medical field, a high school diploma or Bachelor’s degree preferred, and strong communication skills.

Qualifications

• High school diploma or equivalent; Bachelor’s degree preferred.
• 0-3 years of experience in the medical field.
• Knowledge of Federal regulations protecting human subjects in research.
• Strong leadership and mentorship skills.
• Developing and maintaining effective working relationships at all levels of the organization.
• Crisis management and problem solving; ability to react calmly under emergent situations.
• Works independently as well as part of a team.
• Excellent verbal and written communication skills.

Responsibilities

• Coordinate all aspects of patient involvement from study initiation to completion.
• Organize research information for clinical trials.
• Observe subjects and assist with data analysis and reporting.
• Schedule data collection.
• Document adverse events and protocol deviations.
• Report research data to maintain quality and compliance.
• Perform administrative and regulatory duties related to the study.
• Participate in protocol development activities.
• Ensure site receives accurate information and supplies from sponsors.
• Educate participants and caregivers on protocol details.
• Perform safety and efficacy assessments per protocol.

Skills

Leadership

Mentorship

Crisis management

Communication

Teamwork

Education

Bachelor's degree

High school diploma

Job description

About Us:

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation of, and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Compensation:

$26.90-$34.35 /hr depending on education, experience and skillset

Essential Responsibilities and Duties:

• Assists with coordinating all aspects of patient involvement from study initiation until study completion.
• Organizes research information for clinical trials.
• Observes subjects and assists with data analysis and reporting.
• Schedules the collection of data.
• Documents adverse events, protocol deviations, and other unanticipated problems appropriately.
• Reports research data to maintain quality and compliance.
• Performs administrative and regulatory duties related to the study as appropriate.
• Participates in other protocol development activities.
• Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
• Educates potential participants and caregivers on protocol specific details and expectations.
• Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• High school graduate or equivalent; Bachelors Degree, preferred.
• 0-3 years of experience in the medical field.
• Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
• Strong leadership and mentorship skills.
• Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
• Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
• Works independently as well as functioning as part of a team.
• Must be able to effectively communicate verbally and in writing.

Working Conditions

1. Indoor, Office environment.
2. Shift work, depending on location.
3. Essential physical requirements include sitting, typing, standing, and walking.
4. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds.
5. Reporting to work, as scheduled, is essential.
6. Overnight travel may be required for training and/or investigative meetings.

Equal Opportunity Employer

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.