Chenega Corporation TBI Research Coordinator in Bethesda, Maryland

American Hospital Services Group LLC

Company Job Title:

TBI Research Coordinator

Clearance:

NACI

Location:

WRNMMC – Bethesda MD

Reports To:

Program Manager

FLSA Status:

Exempt, Full Time, Regular

Prepared Date:

05-16-2018

Approved Date:

05-16-2018

Summary: TheTBI Research Coordinatoris responsible for coordinating and assuring integrity of all activities associated with conducting a clinical trial. Will ensure compliance with local, state, and/or federal regulatory requirements.

Essential Duties and Responsibilities:(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)

  • Coordinates and assures integrity of all activities associated with conducting a clinical trial as it relates to compliance with local, state, and/or federal regulatory requirements.

  • Collaborates with Principal Investigators in the preparation and submission of clinical protocols, consent forms, and other documents to the scientific review committee, IRB and other regulatory organizations.

  • Maintains regulatory files related to DVBIC clinical investigations.

  • Communicates with research participants, staff, regulatory affairs and data management groups, laboratory and clinical investigators, management, and outside collaborators.

  • Recruits, interviews, examines, counsels, and educates clinical trial volunteers, administer and obtain informed consent.

  • Collect and analyze data to evaluate volunteer eligibility for enrollment.

  • Collect, analyze and interpret laboratory and clinical data obtained during a medical evaluation, report significant values, findings, and events that require prompt attention to clinical investigators.

  • Document and report adverse events, completes and reviews Case Report Forms for patient eligibility, protocol compliance, omissions, errors, and submits these forms as required.

  • Prepares and maintains written and electronic volunteer databases/logs.

  • Perform data extraction and chart reviews of patients’ medical records.

  • Reviews the source document file for information such as verification of critical variables, entrance criteria, visit date, and lab data.

  • Ensures that research records are stored and secured properly, and that inventory and records are updated and properly maintained.

  • Conducts data verification as indicated, documents, collaborates with the investigator and protocol coordinator to answer any questions, may transcribe and resolve queries of data in case report forms (hardcopy or electronic).

  • Prepares documents, under direction of project leads.

  • Reports statistical analyses and descriptive data from patient's study books to be used in research reports.

Non-Essential Duties:

  • Other duties as assigned

Supervisory Responsibilities:

  • NONE

Minimum Qualifications:(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)

  • Bachelor's Degree or higher in biology, psychology or related science required.

  • Must have Human Subjects training completed. Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred.

  • Must maintain Continuing Education credit sufficient to maintain both their clinical license and to meet medical facility specific Quality Assurance standards for credentialing when applicable.

  • Minimum Experience: two (2) years clinical trial experience required.

  • Prior experience within the DoD/VA systems of care strongly preferred.

  • Required Licenses: None. Specialty Healthcare License preferred.

Knowledge, Skills and Abilities:

  • Excellent communication skills, basic clinical acumen, knowledge of universal precautions, organizational skills and proficiency in research conduct are required.

  • Knowledge of standard qualitative and quantitative data collection techniques; ability to follow general instructions; work in a team; good communication, writing and analytical skills; familiarity with social science research methodology is required.

  • Ability to follow detailed instructions. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

Diversity:

  • Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.

Ethics:

  • Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.

  • Must be able to sit and stand for long periods of time.

  • May encounter patients who are confused, agitated, or abusive.

Work Environment:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  • The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment.

  • During visits to areas of operations, may be exposed to extreme cold or hot weather conditions. Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise.

  • Office and clinical environment. Must be available to travel locally, regionally and nationally.

Chenega Corporation and family of companies is an EOE.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity

Native preference under PL 93-638.

We participate in the E-Verify Employment Verification Program.

Minimum Qualifications:(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)

  • Bachelor's Degree or higher in biology, psychology or related science required.

  • Must have Human Subjects training completed. Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred.

  • Must maintain Continuing Education credit sufficient to maintain both their clinical license and to meet medical facility specific Quality Assurance standards for credentialing when applicable.

  • Minimum Experience: two (2) years clinical trial experience required.

  • Prior experience within the DoD/VA systems of care strongly preferred.

  • Required Licenses: None. Specialty Healthcare License preferred.

Job: Medical Research

Organization: American Hospital Services Group (AHSG)

Title: TBI Research Coordinator

Location: Maryland-Bethesda

Requisition ID: 1800001590