Clinical Research Coordinator

Responsible for providing support to the Clinical Research Coordinator (CRC) in collecting data, providing documentation and record keeping activities pertaining to clinical research studies under the direct supervision of a CRC and/or the Director of Clinical Research. The CRC-E position is an entry level position for those processing the skill set and clinical experience that with training and experience will be able to assume the position of a CRC. The CRC-E will provide the necessary support to the CRC to promote Good Clinical Practices in the conduct of clinical investigations.
Participates in Protocol Assessment/Planning Activities by providing support to the CRC and/or Director of Clinincal Research in: Determination of subject population availability; Determines equipment and facility availability for new study.Particpates in the Planning and Implementation Pre-Initiation Activities by providing support to the CRC and/or Director of Clinincal Research in: Assists Director, Clinical Research and CRC in preparing and submitting regulatory documents to sponsors (e.g. Form FDA 1572, laboratory certification and normal valves, curriculum vitae etc.); Assists Director, Clinical Research and CRC in preparing and submitting documents to institutional review board; Attends and participates in investigator meetings; Schedules and coordinates pre-study site visit; Confirms that contact, indemnification letter, IRB approval of protocol and informed consent have been received prior to study initiation.Participates in Subject/Patient Recruitment, Evaluation of Eligibility under the supervision and guidance of the CRC and/or Director of Clinical Research: Monitors enrollment goals and modifies recruitment plan as necessary; Initiates query requests to IS Department if appropriate for study; Reviews and verifies required source documents in subject's medical record to confirm study eligibility; Reviews inclusion/exclusion criteria with investigator to assure subject eligibility; Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures and visits; Obtains informed consent from research subjects prior to any study-related procedures and documents appropriately; Maintains patient screening enrollment logs.Participates in Subject/Patient Recruitment, Enrollment, Study Visits under the supervision and guidance of the CRC and/or Director of Clinical Research: Assures that all screening, eligibility, and enrollment procedures are performed; Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects; Follows randomization procedures as per protocol; Dispenses study drugs per protocol;
Reviews diaries and questionnaires completed by subject as appropriate; Performs phlebotomy functions as indicated by the study protocol; Ensures appropriate specimen collection, batching and shipping as required; Schedules subjects for follow-up visits; Assesses subject compliance with the test drug on follow up visits; Recognizes and reports abnormal laboratory values and alerts to investigator and sponsor; Collects and documents adverse event information for evaluation by the investigator and reports to study sponsor and CRO in a timely mannerProtects Subjects Confidentiality: Protects patient privacy during initial and follow-up interviews and visits; Secures safe storage of study-related documents; Assures appropriate disposal of sensitive documents as appropriate; Secures a permanent and safe location for all archived files.Documents and maintains All Study-Related Procedures, Processes and Events- under the supervision and guidance of the CRC and/or Director of Clinical Research: Documents protocol deviations and exemptions; Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results) as needed; Abstracts data from medical records, clinic, consultation and referral notes to study forms and flowsheets; Records accurate and timely data onto case report forms; Maintains source documentation for all case report entries, as applicable; Keys data for electronic submission, if applicable; Transmits data via fax, mail or electronically as requested by sponsor or CRO; Corrects and edits case report form entries as appropriate; Resolves data queries; Completes and maintains all study drug accountability records including drug dispensing log; Reviews returned drugs for compliance and accurately documents findings; Maintains files of all study related documentation.Communicates Effectively with Subjects, Research Team, IRBs and Sponsors under the supervision and guidance of the CRC and/or Director of Clnical Research: Reviews protocol requirements with ancillary support staff (i.e., nursing, residents, pharmacist); Maintains list of sponsor/CRO contacts for each protocol; Provides subjects with information about reporting study-related events to research team; Establishes a mechanism to contact subjects for follow-up visits, new information, etc.; Utilizes a phone log to document telephone communications; Contacts primary care providers to discuss/inform of patient enrollment and study progress; Meets regularly with investigator and research team to discuss subject participation and protocol progress; Submits protocol amendments and progress report to IRB in required time frames; Timely notification of the investigator, sponsor and IRB of adverse events as outlined in the protocol.Participates in Monitoring Visits and Audits under the supervision and guidance of the CRC and/or Director of Clnical Research: Schedules sponsor monitoring visits; Prepares case report forms for sponsor/audit review; Collects source documents for sponsor/audit review; Meets with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues; Prepares for and participates in FDA inspections as needed.Plans and directs Site Operations under the supervision and guidance of the CRC and/or Director of Clnical Research: Assists with the review and development of standard operating procedures manual; Revises and updates procedures based upon regulations and guidance documents; Participates in educational and training activities; Attends continuing education offerings.
REQUIREMENTS
A high school diploma, G.E.D. or equivalent. Includes special certification required for specific jobs.
Over 3 years and up to and including 5 years of experience in a clinical care environment
Good verbal, written, and telephone skills
Clinical experice in some capacity.Customer service oriented.
Ability to concurrently perform multiple tasks
Computer literacy
Current California drivers license