Clinical Research Coordinator

Charleston Area Medical Center

Charleston (WV)

On-site

USD 56,000 - 75,000

Full time

3 days ago

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Job summary

Charleston Area Medical Center is seeking a Clinical Research Coordinator for the Cancer Research Center in the Cancer Center Building, US-WV-Charleston. You will coordinate trial protocols, manage data, and support IRB/regulatory activities while communicating with sponsors and PI.

A Master’s degree and 2–3 years of research experience are required, with potential substitution as specified by policy. Responsibilities include regulatory document preparation, budget oversight, patient scheduling,

Qualifications

Ability to obtain and interpret information to assess patient needs.
Knowledge of growth and development applicable to patients.
Understanding of range of treatment needs by patients.

Responsibilities

Coordinate study protocol requirements and data collection.
Manage scheduling, visits, procedures, and lab testing for trials.
Prepare regulatory and budget documents for studies.
Document visits, CRFs and study progress for sponsors.

Skills

Clinical research coordination

Regulatory compliance

IRB knowledge

Data collection

Budget tracking

Study documentation

Education

Master's Degree (Required)

2-3 years clinical research experience

Master's substitute option with related degree + experience

LPN/CST with 5-7 years clinical experience

Job description

Clinical Research Coordinator -- Cancer Research Center -- Cancer Center Building (Job ID: 81474)

Coordinates all aspects of clinical research trials. Assists in managing relationships with sponsors, physicians, applicable departments, and other staff for organizational research studies/projects. Manages research projects as assigned by the Operations Director of the Clinical Trials Center (CTC).

Responsibilities

Research Study Management 45%

Develops deep understanding of protocol requirements for each study
Collects and manages data per study protocol
Coordinates Management of patients during trial participation to include, but not limited to scheduling of protocol required visits, procedures, labs, testing, etc.
Orders study supplies as necessary
Processes and organizes new investigational product as it arrives
Provides documentation to pharmacy for investigational drug dispensing
Appropriately documents participant study visits
Transcribes source information onto the Case Report Forms (CRFs)
Resolves queries on study data
Coordinates study subject reimbursement
Documents and communicates study progress to sponsors and management
Tracks study budget and payments

Administrative/Regulatory 30%

Assists Principal Investigator in determining study feasibility
Assists Clinical Trials Director with development of study budget for assigned study.
Prepares documents for the Institutional Review Board (IRB)
Processes IRB packets for signatures and approvals as directed
Ensure that tests, procedures and research activities are conducted in compliance with the approved protocol
Works closely with other departments and clinics as applicable to ensure that protocol required activities are completed efficiently and per quality standards, regulations and policies.
Maintains test article (drug or device) accountability
Oversees storage and administration of study medication
Prepares, submits and maintains regulatory documents (e.g. IRB, Food and Drug Administration (FDA), etc.)
Processes addendums to active protocols
Documents that the IRB has been notified of a protocol change as appropriate
Identifies, documents, reports and manages follow-up for adverse events
Maintains accurate approval and tracking documentation
Coordinates, prepares for and participates in monitoring visits, regulatory body audits and inspections
Closes out the study, assures appropriate storage of study documentation and other subject-oriented tasks

Physician and Patient Communication 20%

Communicates with sponsor and PI regarding trial startup, progress and closure
Communicates with the IRB, staff and other personnel as required
Educates staff regarding study protocol
Screens subjects for study eligibility and recruits/enrolls study subjects
Discusses the study with subjects and carries out the consent process
Schedules study visits and protocol research activities
Interviews & evaluate subjects within the required time intervals provided in the protocol
Communicates all IRB approved protocol changes to appropriate stakeholders
Shares data and information gathered from research activities with the PI

Teamwork/Development 3%

Assist in onboarding and mentoring new employees as assigned
Maintain education and knowledge in institutional and regulatory policies and processes. Participate in departmental or study meetings as directed

Business Development 2%

Markets CAMC as a clinical trials site to sponsors
Maintains relationships with study sponsors and applicable departments and clinics.
Develops and manages advertising for studies in collaboration with Marketing and Communications as appropriate

Knowledge, Skills & Abilities

Patient Group Knowledge (Only applies to positions with direct patient contact)

The employee must possess/obtain (by the end of the orientation period) and demonstrate the knowledge and skills necessary to provide developmentally appropriate assessment, treatment or care as defined by the department’s identified patient ages. Specifically the employee must be able to demonstrate competency in: 1) ability to obtain and interpret information in terms of patient needs; 2) knowledge of growth and development; and 3) understanding of the range of treatment needed by the patients.

Competency Statement

Must demonstrate competency through an initial orientation and ongoing competency validation to independently perform tasks and additional duties as specified in the job description and the unit/department specific competency checklist.

Common Duties and Responsibilities

(Essential duties common to all positions)

1. Maintain and document all applicable required education.

2. Demonstrate positive customer service and co-worker relations.

3. Comply with the company's attendance policy.

4. Participate in the continuous, quality improvement activities of the department and institution.

5. Perform work in a cost effective manner.

6. Perform work in accordance with all departmental pay practices and scheduling policies, including but not limited to, overtime, various shift work, and on-call situations.

7. Perform work in alignment with the overall mission and strategic plan of the organization.

8. Follow organizational and departmental policies and procedures, as applicable.

9. Perform related duties as assigned.

Education

Master's Degree (Required)
Experience: 2-3 years of experience
Substitution: May substitute Master's degree for an Associate or Bachelor’s degree in a related field paired with additional relevant experience
Licensed Practical Nurse (LPN) designation with Certified Surgical Technologist (CST) designation with 5-7 years of professional clinical experience. Certification must be current and remain current throughout employment

Credentials