Job Description
Description
Clinical Research Coordinator Job Summary The Clinical Research Coordinator is responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and / or manual of procedures. Day to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.
Duties / Responsibilities Level I
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
- Administer sponsor required questionnaires (i.e. VFQ).
- Works with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensure adequate inventory is on hand.
- Ensures study staff is properly trained on study-related information (i.e. protocol, ICF, manuals, etc.) and that the training is documented.
- Creates, manages, and maintains source documents for each trial.
- Attends teleconferences and investigator meetings as requested by research director.
- Reviews and comprehends all study protocols, e.g. study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
- Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals.
- Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility accurately.
- Efficiently completes all study tasks delegated to them (i.e. scribing, VFQ, IOP, etc.).
- Collects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within the required timeframe.
- Conducts and / or participates in the informed consent process / discussion with research participants, including answering any questions related to the study.
- Assures that amended consent forms are appropriately implemented and signed.
- Acts as a secondary reviewer to provide oversight so that the ICF process is conducted accurately.
- Collects data as required by the protocol and enters information into the electronic data capture (EDC) system in the specified timeframe indicated in the study contract.
- Oversees data and ensures that it is being entered correctly and resolves any queries issued within the required timeframe. • Collects and reports ALL Adverse Events.
- Collects and reports ALL Serious Adverse Events.
- Responsible for ensuring all SUSAR / Safety Reports are acknowledged and reviewed.
- Coordinates monitor site visits and assists with preparation of site visit documentation.
- Works with the monitor site visits and assists with preparation of site visit documentation.
- Works with the monitor to make any corrections needed to meet requirements and deadlines as needed.
- Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and sponsor.
- Obtain any applicable additional / required sponsor training and / or certifications.
Level II (in addition to Level I)
- Primary coordinator for multi-site studies within the practice.
- Primary sponsor lead for multi-sites within the practice.
- Reviews in-depth medical and / or hospital records for Serious Adverse Events.
- Is proficient in all aspects of the CTMS system (i.e. running reports).
- Mentors and trains research assistants and study coordinators.
Level III (in addition to Level I & Level II)
- Primary coordinator for multi-site studies within the practice.
- Provides leadership to the team.
- Travel to other RCA sites for mentoring and collaboration.
- Mentors and trains research assistants and study coordinators within practice.
Requirements About the Candidate Preferred Skills / Abilities - Efficiently and accurately interviews patients and documents histories.
- Demonstrates working knowledge of eye anatomy, disease, symptoms, and ocular medications.
- Accurately performs labs, ECG, tonometry, pupil exam, data entry, and other specified duties.
- Possesses excellent organizational skills to independently manage workflow.
- Pays meticulous attention to detail.
- Takes initiative.
- Possesses insight and energy to prioritize quickly.
- Demonstrates high-level critical thinking skills.
- Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional manner.
- Demonstrates excellence in communication skills, both personal and written.
- Abounds in organizational time-management skills.
Education and Experience Level I
- Bachelor's degree in a related field preferred; combined experience and education as a substitute for minimum education.
- Ophthalmic experience preferred.
- Experience as RA III for one to three years or prior annual review or promotion assessment exceeds expectations and shows high proficiency in the job requirements.
- ICH GCP Training / Certification.
- IATA Certification.
Level II
- Level I Coordinator for more than one year.
- Prior annual review or promotion assessment exceeds expectations and shows proficiency in the job requirements.
Level III
- Level II Coordinator for more than one year.
- Prior annual review or promotion assessment exceeds expectations and shows proficiency in the job requirements.
- SOCRA / ACRP Certification.
Job Tags
Full time, Contract work,