Clinical Research Coordinator I

Target Salary $55,000-65,000

No CRC

Purpose and Scope:

The primary responsibility of the research coordinator is to manage all logistical aspects of conducting clinical trials. The research coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practice set forth by federal regulations. As the primary resource for the protocols, the research coordinator will act as a liaison between the investigators, primary care providers, and ancillary services. In partnership with the investigator, the research coordinator will screen, enroll and follow study subjects, ensuring protocol compliance. In addition, the research coordinator is responsible for data collection, source documentation and adverse event reporting. The research coordinator serves as a liaison between the Sponsor/CRO and the site for patient related activities associated with a specific protocol and onsite trial activities related to trial oversight.

Qualifications/Skills

The following, or equivalents, are the minimum requirements to perform the essential functions of this position.

• Bachelor’s Degree preferred or equivalent education and experience

• Minimum of 2 years of experience in clinical trials experience or healthcare data management

• Professional level experience in planning, organizing and process management is desired

• Possesses functional knowledge of GCP and ICH Guidelines

• Knowledge of medical and clinical research terminology

• SOCRA or ACRP certification preferred

• Maintains knowledge of and adherence to HIPAA regulations appropriate to position

• Effective time management and analytical skills

• Excellent communication skills

Principal Duties and Responsibilities

• Provides protocol specific information and necessary training for physicians, staff, and patients

for each protocol

• Creates protocol specific source documents

• Identifies, screens and enrolls subjects into clinical trials

• Participates in informed consent process and documents appropriately

• Assures patient eligibility is satisfied prior to enrollment and/or protocol assessments and

randomization

• Coordinates and executes protocol events and required follow-up with patient, medical staff,

and ancillary staff personnel

• Schedules research related tests and appointments per protocol

• Performs study specific procedures within scope, as needed

• Collects, processes and ships study labs to central and local labs, as needed

• Monitors study patients to assure treatment and follow-up are conducted according to protocol

and sponsor guidelines

• Reviews laboratory data and provides to Principal Investigator/Sub-Investigator for review and

signature

• Assesses and documents subject compliance with medications and visits

• Provides patient care and oversight for subjects in the active treatment, short-term follow-up,

and long-term follow-up phases of trial (including conducting phone calls, visits, or

communications).

• Obtains investigational product assignments and distributes assignment, as needed

• Assures timely and accurate study drug distribution

• Maintains accurate record of IP and drug supplies, as appropriate

• Records all adverse events as outlined in protocol and provides to study physician to assess

causality

• Reports all serious adverse events to the principal investigator, sponsor, primary care physician

and IRB as outlined in the protocol

• Reviews safety reports and collects the study physician’s signature as required by sponsor or IRB

• Coordinates/conducts activities with the collection, preparation and shipment of protocol

related samples within specified parameters

• Records time and type of work activity in Clinical Conductor

• Obtains appropriate signatures on study documents, as needed

• Schedules and organizes monitoring visits

• Completes follow-up tasks required after monitoring visits are completed, as needed

• Collects, compiles and records data on case report forms according to protocol requirements

• Addresses data queries in a timely manner, according to protocol requirements

• Responsible for real-time maintenance of up-to-date patient information, including

treatment/follow-up status and patient event certification which drives the billing process

• Ensures quality data, responsible for the overall accuracy and timeliness of data submitted into

sponsor’s EDC system

• Participates as needed in ongoing quality assurance and control processes, and preparation of

records for internally or externally sponsored audits and FDA audits

• Collaborates in the review of new/proposed protocols to substantiate the feasibility of studies

and non-competing nature of new studies under consideration

• Attends study-related meetings, as appropriate

• Communicates regularly with the site investigators and clinical staff about study-related issues

• Maintains trainings such as CITI, NIH, IATA and HIPAA training as required

• Performs other duties as assigned

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