Clinical Research Coordinator

Description

Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH, GCP, protocol, and company guidelines, regulations, and policies.

ICH: International Conference on Harmonization

GCP: Good Clinical Practices

MUST HAVE: 1+ yr industry experience at a CRC, EKG, patient visits, SIV (no phlebotomy).

Essential Responsibilities and Duties:

• Coordinates all aspects of patient involvement from study initiation until study completion.

• Study start-up activities: Assists in the creation of thorough and accurate source documents.

• Study start-up activities: Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.

• Study start-up activities: Participates in IMs (Inclusion Management) and SIVs (Site Initiation Visits); communicating with sponsors and representatives.

• Study start-up activities: Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.).

• Screening and enrolling activities: Assists in reviewing all participant history from Pre-Enrollment and Enrollment departments confirming information with potential participant and study physician.

• Screening and enrolling activities: Educates potential participants and caregivers on protocol specific details and expectations.

• Screening and enrolling activities: Works with the physician to address all questions and concerns related to the trial and informed consent process.

• Screening and enrolling activities: Maintains thorough knowledge of study specific inclusion/exclusion criteria.

• Coordinates scheduled visits, adhering to protocol visit windows and timelines.

• Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).

• Collaborates with the research pharmacist to perform drug accountability and compliance at each visit and educating subject on proper dosing regimen.

• Accurate and timely completion of source documents recording subject’s participation in study.

• Communicates closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines.

• Assists investigators in collection of information from study subjects regarding AEs (Adverse Events), concomitant medications and other changes throughout participation.

• Timely reporting of study status, study related issues, and study events (SAEs [serious adverse events], protocol deviations, etc) to appropriate management, internal departments and other outside agencies (Sponsors, CRO’s [contract research organization], etc.)

• Responsible for subject scheduling and follows subjects through study completion and creates follow-up care plan with physician, study subject and primary care provider.

• Prepares and facilitates all study monitoring visits and follows up promptly with monitor follow-up letters.

• Prompt and professional communication with sponsors, representatives and other study related parties.

• Maintains professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff members.

• 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.

Qualifications

• 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.

• Proficient in the use of technology required for the completion of study visits and study conduct.

• High level of ability to complete paperwork with precision, accuracy, and attention to detail; meet timelines; and prioritization.

• Experience with medical equipment and instruments to administer study subject care.

• Knowledge of medical terminology.

• Must be able to effectively communicate verbally and in writing.