Easter Seals Jobs

SUMMARY

The Clinical Studies Coordinator collaborates with the research team and the principal investigator by becoming knowledgeable in current protocol requirements and by collecting protocol-specific information from physicians, nurses, patients, family members, local caregivers and others utilizing a computer database and/or case report forms. In addition, he/she participates in retrieval and analysis of protocol specific data and or disease treatment related information.

JOB SPECIFIC COMPETENCIES Clinical Protocols

• Assesses patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.

• On a real-time basis, assesses the patient's clinical status as per protocol requirements by coordinating, evaluating and following the patient's participation in clinical trials including collaborating with the entire medical care team as necessary, assisting protocol serious adverse events (SAE) reporting, participating in Quality Assurance (QA) procedure for reporting and monitoring Serious Adverse Events.

• Provides documentation in the patient's medical record, protocol specific documents, and institutional requirements.

• Communicates availability of protocol treatments for accrual.

• Maintains the institutional patient regulatory protocol requirements (deviation logs, SAEs, AE logs, IRB continuing review, etc.).

• Participates in monitoring, audit activities, SIVs, conference calls, interim assessments, protocol meetings, and email/written business correspondence.

• Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies.

• Notifies clinical and/or research laboratories of protocol-required laboratory tests including EKGs, PKs, PDs, urine collection, etc.

• Prepare orders for protocol-related tests, procedures, consults, requests for pathology slides and blocks as needed.

• Communicates verbally and in writing with primary investigator, other protocol managers, clinical staff to ensure protocol patient safety and protocol compliance.

• Conveys information clearly, accurately, and concisely through both formal and informal communication.

• Provides coverage for other protocol managers.

• Informs appropriate staff and arrange coverage for necessary functions when absent.

• Work in situations involving uncertainty, shifting priorities, and rapid change; deal constructively with mistakes and setbacks; demonstrate flexibility.

Protocol Data

• Assists the primary investigator in collection and evaluation of data.

• Oversees protocol-related data documentation in the medical record.

• Collaborates with data entry staff to ensure data is accurately entered into required database or on a handwritten case report form.

• Reviews patient response to treatment, treatment toxicities and adverse drug reactions with the principal investigator.

• Reports to the Institutional Review Board and the study sponsor.

• Provides protocol summary reports as requested.

Patient and Professional Education

• Identifies patient and family educational needs regarding treatment management, evaluation, and follow-up in clinical trials through talking with patients person-to-person or by telephone and provides appropriate education and/or educational materials.

• Ensures human subjects protection in accordance with federal, state and institutional requirements.

• Facilitates the patient's provision of initial informed consent and re-consent.

• Addresses research participants' inquiries and concerns.

• Provides professional and ancillary staff education concerning research protocols by preparing in-service materials and performing protocol in-service as needed.

• Provides accurate information as requested to the multidisciplinary team.

• Keeps current concerning oncology and research study management issues through reading and or attending meetings/in-services.

Other duties as assigned.

EDUCATION

Required: Bachelor's degree.

Preferred: Master's degree.

EXPERIENCE

Required: Three years' experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one-to-one basis. With preferred degree, one year of required experience.

Preferred: Clinical trial coordination and direct patient care experience. D ata collection/analysis experience.

CERTIFICATION

Required: None.

Preferred: Certification in Society of Clinical Research Associates (SOCRA), or Certified Clinical Research Professional (CCRP).

Onsite Presence: Is Required

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

Additional Information

• Requisition ID: 172372

• Employment Status: Full-Time

• Employee Status: Regular

• Work Week: Days

• Minimum Salary: US Dollar (USD) 53,000

• Midpoint Salary: US Dollar (USD) 66,000

• Maximum Salary : US Dollar (USD) 79,000

• FLSA: non-exempt and eligible for overtime pay

• Fund Type: Soft

• Work Location: Hybrid Onsite/Remote

• Pivotal Position: No

• Referral Bonus Available?: No

• Relocation Assistance Available?: No

• Science Jobs: No

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