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Clinical Research Administrator I/Clinical Research Administrator II/Clinical Research Administrator III

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Please see Special Instructions for more details.

Monday-Friday, 8:00 AM to 5:00 PM with flexibility to address demands of the position and the Office of Clinical Research. Employment in this position is contingent upon consent to and successful completion of a pre-employment background check, which may include a criminal background check, reference checks, verification of work history, and verification of any required academic credentials, licenses, and/or certifications, with results acceptable to Dartmouth College. A criminal conviction will not automatically disqualify an applicant from employment. Background check information will be used in a confidential, non-discriminatory manner consistent with state and federal law.

Position Details

Position Information

Position Title Clinical Research Administrator I/Clinical Research Administrator II/Clinical Research Administrator III
Department NCCC
Position Number 1010108
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Seeking an individual with a Bachelor’s degree, preferably in the Life Sciences or Health Sciences to manage clinical trials for new cancer treatments at the Norris Cotton Cancer Center (NCCC) / Geisel School of Medicine at Dartmouth. Experience in cancer clinical trials coordination is preferred, and professional certification through SOCRA or ACRP is highly desirable. The successful candidate will have good judgment, initiative, and an ability to maintain the highest level of confidentiality. Excellent organizational and communication (oral and written) skills required. Project management experience is a plus. Must have an ability to balance competing demands and make decisions under deadline pressures. Knowledge of diagnostic and treatment modalities in oncology/hematology; clinical trial design and analysis; and, federal regulations relating to research in human subjects is preferred. Skill in reading and interpreting experimental protocols is essential. Strong computer skills are required due to electronic management clinical trial data.

Position Purpose

CLINICAL RESEARCH ADMINISTRATOR I (Non-Exempt)
To accomplish all adverse event reporting actions in a timely manner and provide support to Norris Cotton Cancer Center (NCCC) Clinical Research Office staff.

CLINICAL RESEARCH ADMINISTRATOR II (Non-Exempt)
To coordinate clinical trials of new cancer treatments for one or more clinical teams at Norris Cotton Cancer Center (NCCC).

CLINICAL RESEARCH ADMINISTRATOR III (Exempt)
To plan and coordinate clinical trials of new cancer treatments for one or more clinical teams at the Norris Cotton Cancer Center (NCCC). As a senior member of the NCCC clinical research team, to manage a major Clinical Research Office administrative activity and to train and mentor junior clinical research staff.

Skills & Knowledge

CLINICAL RESEARCH ADMINISTRATOR I (Non-Exempt)

  • Familiarity with medical terminology.
  • Excellent oral and written communication skills.
  • Competency with computerized spreadsheets and word processing.
  • Ability to handle multiple concurrent tasks and deadlines.
  • Tact and discretion in dealing with patients and outside medical professionals.
  • Ability to balance competing demands, and make decisions under deadline pressures.
  • Commitment to diversity and to serving the needs of a diverse community.

CLINICAL RESEARCH ADMINISTRATOR II (Non-Exempt)

  • Knowledge of diagnostic and treatment modalities in oncology and hematology.
  • Knowledge of clinical trials design and analysis.
  • Knowledge of federal regulations related to research in human subjects.
  • Skill in reading and interpreting experimental protocols.
  • Facility with computerized data management and the organization of quantitative data.
  • Judgment, initiative, discretion.
  • Very strong organizational ability.
  • Excellent oral and written communication skills.
  • Ability to balance competing demands, and make decisions under deadline pressures.
  • Commitment to diversity and to serving the needs of a diverse community.

CLINICAL RESEARCH ADMINISTRATOR III (Exempt)

  • Strong knowledge of diagnostic and treatment modalities in oncology and hematology.
  • Strong knowledge of clinical trials design and analysis.
  • Strong knowledge of federal regulations related to research in human subjects.
  • Skill in reading and interpreting experimental protocols.
  • Facility with computerized data management and the organization of quantitative data.
  • Judgment, initiative, discretion.
  • Very strong organizational ability.
  • Excellent oral and written communication skills.
  • Ability to balance competing demands, and make decisions under deadline pressures.
  • Commitment to diversity and to serving the needs of a diverse population.
Minimum Experience

CLINICAL RESEARCH ADMINISTRATOR I (Non-Exempt)

  • Two years of relevant experience in a medical care or research data management environment, preferably in an oncology setting.

CLINICAL RESEARCH ADMINISTRATOR II (Non-Exempt)

  • Three years of relevant experience in cancer clinical trials coordination.

CLINICAL RESEARCH ADMINISTRATOR III (Exempt)

  • Five years of relevant experience in cancer clinical trials coordination.
Minimum Education

CLINICAL RESEARCH ADMINISTRATOR I (Non-Exempt)

  • Associate degree or the equivalent.

CLINICAL RESEARCH ADMINISTRATOR II (Non-Exempt)

  • Bachelors’ degree preferably in the Health Sciences.
  • Professional certification as a Clinical Research Administrator, preferred

CLINICAL RESEARCH ADMINISTRATOR III (Exempt)

  • Bachelors’ degree, preferably in the Health Sciences.
  • Professional certification as a Clinical Research Administrator.
SEIU Level Not an SEIU Position
FLSA To Be Determined
Employment Category Regular Full Time
Department Contact for Cover Letter Michael Sainz, Administrative Director, Office of Clinical Research
Equal Opportunity Employer

Dartmouth College is an equal opportunity/affirmative action employer with a strong commitment to diversity and inclusion. We prohibit discrimination on the basis of race, color, religion, sex, age, national origin, sexual orientation, gender identity or expression, disability, veteran status, marital status, or any other legally protected status. Applications by members of all underrepresented groups are encouraged.

Special Instructions to Applicants

Monday-Friday, 8:00 AM to 5:00 PM with flexibility to address demands of the position and the Office of Clinical Research.

Employment in this position is contingent upon consent to and successful completion of a pre-employment background check, which may include a criminal background check, reference checks, verification of work history, and verification of any required academic credentials, licenses, and/or certifications, with results acceptable to Dartmouth College. A criminal conviction will not automatically disqualify an applicant from employment. Background check information will be used in a confidential, non-discriminatory manner consistent with state and federal law.

Key Accountabilities

Key Accountabilities

CLINICAL RESEARCH ADMINISTRATOR I (Non-Exempt)

Adverse event reporting

  • Reviews and interprets adverse event reports sent by pharmaceutical study sponsors of situations that occurred in outside institutions to determine applicability to NCCC studies.
  • Prepares and presents adverse event summaries to NCCC physicians, who will determine further actions to be taken.
  • Coordinates responses from multiple physicians in order to resolve and establish the correct category.
  • When necessary, reports adverse event to IRB, National Cancer Institute, FDA, etc.
  • Monitors other required actions (e.g., informed consent changes, reports to FDA or NCI) to ensure complete follow-up on adverse event reports.
  • Communicates with pharmaceutical sponsor regarding actions taken.

Long-term study subject follow-up

  • Coordinates all follow-up contacts required by protocol with study subjects, after they complete their clinical trial active treatment.
  • Contacts patients, outside clinicians, and cancer registrars throughout the United States to determine disease and survival status.
  • Reviews patient medical record to obtain information about disease and survival status.
  • When necessary, obtains and sends medical release of information forms to outside institutions.
  • Establishes and maintains a centralized computerized tracking system for patient follow-ups.

Regulatory Documents

  • Maintains complete and updated library of regulatory documents for use by NCCC Clinical Research Office staff, including physician CVs, lab certifications, federal 1572 forms, financial disclosure forms, and IRB policies.

Site Visit Coordination

  • Sets up site visits for new studies.
  • Distributes copies of protocol, reserves meeting room and any required audiovisual equipment.
  • Schedules tours of areas outside the Cancer Center (lab, pharmacy, infusion room, inpatient unit, etc.).

CALGB Pathology Coordinator

  • Receives communications from CALGB regarding pathology specimen submissions; distributes this information as necessary to NCCC Clinical Research Office staff and DHMC Pathology staff.
  • Receives returned pathology blocks and slides from CALGB; returns material to appropriate location in DHMC Pathology.

CLINICAL RESEARCH ADMINISTRATOR II (Non-Exempt)

Research Coordination

  • Identifies patients potentially eligible for clinical trials.
  • Locates and evaluates diverse types of patient medical information to determine eligibility for investigational treatments.
  • Tracks patient informed consent process and registers patient to study.
  • Works with secretarial, pharmacy, nursing, physician and allied health staff to ensure compliance with all protocol requirements regarding patient treatment and follow-up.
  • Obtains clarification of protocol ambiguities; coordinates with principal investigator as necessary.

Data Management

  • Acquires, evaluates, and compiles information related to investigational treatment regimens for cancer patients.
  • Manages computerized data regarding clinical trial patients. Creates detailed study calendars and ensures completion of all required tests and procedures.
  • Tabulates and formats data for reports and grant applications; prepares statistical reports.
  • Prepares detailed reports of accrual and patient safety information for NCCC Safety and Data Monitoring Committee.
  • Serves in a pivotal role in ensuring the Cancer Center’s compliance with the extensive federal regulations regarding patient safety and confidentiality.

Communication

  • Consults with physicians, nurses, allied health professionals, secretarial staff, federal and local regulatory agencies, industrial study sponsors, and administrative staff regarding complex issues in the conduct of clinical trials.
  • Engages in sensitive and emotionally charged conversations with cancer patients and their families regarding issues related to clinical trial participation.
  • Regularly fields calls from patients and physicians across the country inquiring about clinical trial availability for specific patients and/or diseases.
  • Represents the NCCC Clinical Research program in discussions with clinicians at outside facilities throughout the United States.
  • Represents the NCCC in particularly challenging interactions with outside institutions, federal agencies, contract research organizations, and pharmaceutical firms.
  • Fosters respectful communication and collaboration within a diverse community.

CLINICAL RESEARCH ADMINISTRATOR III (Exempt)

Research Coordination

  • Identifies patients potentially eligible for clinical trials.
  • Locates and evaluates diverse types of patient medical information to determine eligibility for investigational treatments.
  • Tracks patient informed consent process and registers patient to study.
  • Works with secretarial, pharmacy, nursing, physician and allied health staff to ensure compliance with all protocol requirements regarding patient treatment and follow-up.
  • Obtains clarification of protocol ambiguities; coordinates with principal investigator as necessary.
  • Acquires, evaluates, and compiles information related to investigational treatment regimens for cancer patients.
  • Manages computerized data regarding clinical trial patients.
  • Creates detailed study calendars and ensures completion of all required tests and procedures.
  • Assumes responsibility for the most challenging clinical trials at NCCC.
  • Tabulates and formats data for reports and grant applications; prepares statistical reports.
  • Prepares detailed reports of accrual and patient safety information for NCCC.

Safety and Data Monitoring Committee

  • Often co-authors scientific journal articles to report clinical research results.
  • Serves in a pivotal role in ensuring the Cancer Center’s compliance with the extensive federal regulations regarding patient safety and confidentiality.

Communication

  • Consults with physicians, nurses, allied health professionals, secretarial staff, federal and local regulatory agencies, industrial study sponsors, and administrative staff regarding complex issues in the conduct of clinical trials.
  • Engages in sensitive and emotionally charged conversations with cancer patients and their families regarding issues related to clinical trial participation.
  • Regularly fields calls from patients and physicians across the country inquiring about clinical trial availability for specific patients and/or diseases.
  • Represents the NCCC Clinical Research program in discussions with clinicians at outside facilities throughout the United States.

Mentoring and Education

  • Educates patients, patient families, medical students, oncology fellows, and other clinical staff about clinical research standards.
  • Trains and mentors junior staff in the NCCC Clinical Research Office.

Administration

  • Implements and oversees one or more major Clinical Research Office administrative activity.
  • Prepares budget proposals for new industrially funded clinical trials.
  • Collaborates with PI and sponsor agency to conduct project needs assessment.
  • Estimates staffing requirements for study completion, and communicates with outside DHMC departments regarding costs for study-related services.
  • Develops and presents continuing education sessions regarding human subjects regulations for internal staff and other Geisel/DHMC departments.
  • Oversees the update and maintenance of standard operating procedures and quality control measures and evaluates program efficiency.
  • Serves as a formal liaison with Geisel/DHMC departments and other outside activities/organizations involved in clinical research.
  • Regularly attends and/or presents at their staff meetings.
  • Oversees the acquisition and maintenance of resources required for CRO staff.
  • Serves as the CRO expert on federal regulations.
  • Participates in the senior administrative forum of NCCC Clinical Research Office for planning new short-term and long-term CRO initiatives.
  • Participates in rotating assignments as the CRO scheduled on-call administrator during regular work hours.
-- Performs other duties as assigned

Applicant Documents

Required Documents
  1. Resume
  2. Cover Letter
Optional Documents
  1. Additional Document #1
  2. Additional Document #2

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