Clinical Research Coordinator

With no visa restrictions
Job location Minneapolis, MN
Responsible for management and oversight of several Clinical Research studies at one time. Coordinates and oversees the collection of data, documentation and record-keeping activities pertaining to those studies. Promotes good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of FDA regulations and human subject protection thus assuring compliance with protocol and regulatory requirements. Coordinates the study-related activities of the investigator and all subjects.
ESSENTIAL FUNCTIONS:

• Consistently exhibits behavior and communication skills that demonstrate HealthCare Partners' (HCP) commitment to superior customer service, including quality, care and concern with each and every internal and external customer.

Conducts protocol assessment and initiates planning activities:

• Applies knowledge of study design to evaluate protocol feasibility at the site and study start up and closure activities.
• Determines subject population, equipment and facility availability for new study.
• Lists and clarifies questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectation and study procedures.

Plans and implements pre-initiation activities:

• Develops timelines for conducting and completing the clinical protocol and assists with budget tracking and reporting.
• Assists the Director, Clinical Research Operations in preparing and submitting documents to institutional review boards and regulatory documents to sponsors (e.g., Form FDA 1572, laboratory certification and normal valves, curriculum vitae)
• Integrates proposed clinical trial with current research activities.
• Attends and participates in investigator meetings.
• Schedules and coordinates pre-study site visit in conjunction with the Clinical Research Auditor.
• Creates and or modifies sponsor-provided source documents to ensure all data points of the protocol are collected.
• Confirms receipt of contact, indemnification letter, IRB approval of protocol and informed consent prior to study initiation.

Participates in subject / patient recruitment and evaluation of eligibility:

• Collaborates with the Principal Investigator, department NP / PA / RN and the Director, Clinical Research Operations to determine recruitment plan.
• Monitors enrollment goals and modifies recruitment plans as necessary.
• Initiates query requests to IS department for the study.
• Reviews and verifies required source documents in subject's medical record to confirm study eligibility.
• Reviews inclusion / exclusion criteria with investigators to assure subject eligibility.
• Conducts interviews to assess the subject's ability and willingness to follow and complete study procedure and visits.
• Obtains informed consent from research subjects prior to any study-related procedures and documents appropriately.
• Maintains patient screening and enrollment logs.

Supervises subject / patient recruitment, enrollment and study visits:

• 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 and dispenses study drugs per protocol.
• Reviews diaries and questionnaires completed by subject.
• Performs phlebotomy functions (if licensed to do so) as indicated by the study protocol.
• Ensures appropriate specimen collection, batching and shipping as required.
• Schedules subjects for follow-up visits to assess subject compliance with the test drug.
• Recognizes and reports abnormal laboratory values and alerts investigator and sponsor.
• Collects and documents adverse event information for evaluation by the investigator and reports to study sponsor and CRO in a timely manner.

Protects subject confidentiality:

• Protects patient privacy during initial and follow-up interviews and visits.
• Secures a permanent and safe location for all archived files and secures safe storage of study-related documents.
• Assures appropriate disposal of sensitive documents.

Ensures the documentation and maintenance of all study-related procedures, processes and events:

• Documents protocol deviations and exemptions and assists with quality assurance.
• Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results).
• Abstracts data from medical records, clinic, consultation and referral notes to study forms and flow sheets.
• Records accurate and timely data onto case report forms.
• Maintains source documentation for all case report entries.
• Transmits data via fax, mail or electronically as requested by sponsor or CRO.
• Resolves data queries.
• Completes and maintains all study drug accountability records including drug dispensing drug.
• Reviews returned drugs for compliance and documents findings.
• Maintains files for all study-related documentation.

Communicates effectively with subjects, research team, IRB's and sponsors:

• Reviews protocol requirements with ancillary support (i.e., nursing, residents, pharmacy).
• 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 and new information.
• Utilizes a phone log to document telephone communications.
• Contacts primary care providers to discuss and inform 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 within required timeframes.
• Notifies the investigator, sponsor and IRB timely of adverse events as outlined in the protocol.

Responsible for preparation of monitoring visits and audits:

• Schedules sponsor monitoring visits.
• Prepares case report forms and 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.

Plans and directs site operations:

• Assists with the review and development of standard operating procedures manual.
• Revises and updates procedures based upon regulations and guidance documents.
• Mentors and project manages activities of the Clinical Research Coordinator.