Back to Results /
Modify Search /
Clinical Research Coordinator II
The Clinical Research Coordinator II works under the general direction of the Office of Research Affairs' Clinical Research Administration Division, their clinical department / division, and in partnership with the Principal Investigator (PI), Co-Investigator(s), other study personnel, and sponsoring agents to ensure protocols are conducted in accordance with the principles of Good Clinical Practice (GCP) .S/he will coordinate clinical research studies and perform a variety of duties involved in the collection, compilation, and documentation of clinical research data. S/he plays an instrumental role in facilitating the informed consent process and ensuring compliance with the study protocol.
- Adheres to the policies, procedures, and guidelines instituted by the Office of Research Affairs and the Office of Research Compliance. Manages multiple complex clinical research protocols concurrently including, but not limited to grant-funded research, externally sponsored clinical research, and investigator-initiated clinical research conducted on site or its affiliated sites.
- Trains, mentors, and supervises entry level Clinical Research Coordinators, Research Protocol Coordinators, students, residents, and fellows on the basics of clinical research, GCP, Good Documentation Practices (GDP), and the company's SOPs.
- Works closely with the Principal Investigator to coordinate all aspects of conducting clinical trials including screening, enrollment, and study subject visits.
- Assists the Principal Investigator and Department/Research Administrator to review the protocol plan to develop the budget and differentiate the standard of care versus research charges while ensuring all potential costs of the trial are identified and covered by a funding source.
- In conjunction with the Clinical Research Administration Division and Principal Investigator, determines the appropriate patient population, recruits, and maintains the target number of subjects for trial participation.
- Updates the Clinical Research Administration Division, as necessary.
- Maintains accurate and complete documentation of signed informed consent and HIPAA Authorization forms, relevant IRB approvals, source documentation, Case Report Forms (CRFs), Delegation of Authority logs, protocol training log, and study related communications.
- Partners with the study sponsor and Principal Investigator to complete study closure activities such as notification to study subjects, IRB, Clinical Research Administration Division, and Department/Research Administrator.
- Communicates with study subject regarding subject procedures and visit schedule.
- Works closely with the Clinical Research Administration Division to ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance within study sponsor, Principal Investigator, and regulatory agency specifications.
- Organizes and attends site monitoring visits conducted by internal and external auditors/monitors.
- May obtain, process, transport and ship potentially bio-hazardous specimens to appropriate laboratory according to protocol and regulatory requirements
- Performs a variety of duties involved in the collection, compilation, and documentation of clinical research data.
- Follows FDA, OHRP guidelines in the collection of clinical data and/or administration of clinical studies.
- May perform informed consent process for subject enrollment.
- Documents all study subject interactions in the subject's research records.
- Coordinates the submission or submits documents, study protocols, and study protocol amendments to the local IRB per policy and procedure.
- Performs other duties as assigned.
- Bachelor's degree in Science/ Health Related Field is required.
- Certification as a Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professionals (CIP) is preferred.
- Demonstrated knowledge of Good Clinical Practice (GCP) is required.
- A minimum of 2-3 years of clinical research experience is required.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
Find Us on Facebook!
Follow Us on Twitter!
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands provide direct hire, executive search, temporary staffing, contract consulting and temp/contract-to-hire solutions to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Pharma and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.
We look forward to working with you!
Beacon Hill. Employing the Future™
Email this job
Back to Results /
Modify Search /