Project Manager-Clinical Trials [NonExempt]

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Position Summary

The Project Manager-Clinical Trials has primary responsibility over the management of multiple clinical research trials, to include selection and analysis of potential patients for study participation, obtaining informed consent, documentation of all study required case report forms, identifying potential adverse events and reporting them to FDA/IRB/Study Sponsor as applicable. Ensures that site/principal investigator is compliant with approved protocols. Acts as a liaison between patients, their families and other healthcare professionals during their participation in a research trial.

Bachelor’s degree in a nursing, science or healthcare related field is required. 

Master's degree in healthcare, research, business or related discipline is preferred.

Associate's degree in radiology plus 3 years of experience special procedures technologist and/or cardiovascular research may be considered in lieu of bachelor's degree.

2 years healthcare or clinical research experience is required. 

2 years of experience in research is preferred.

Healthcare-related license if applicable. 

Clinical research professional certification (i.e., Certified Clinical Research Coordinator (CCRC) is preferred within 3 years of employment.

Human Subject Protection and Good Clinical Practices Training through the Collaborative Institutional Training Initiative (CITI) required within 30 days of hire.

Demonstrated written communication skills, strong verbal communication and listening skills, effective interpersonal skills, ability to build strong customer relationships and represent company with external constituents.

Above average time management, organizational and priority-setting skills, ability to work within tight timeframes and meet strict deadlines, demonstrated attention to detail with the ability to drive multiple projects to successful completion. Demonstrated project management skills.

High degree of professionalism and commitment to quality, composure under pressure, highly thorough and dependable, performs work with minimal supervision, possesses a high degree of initiative, possesses flexibility to work in a fast-paced, dynamic environment, proactively approaches responsibilities.

Current knowledge and application of all recognized Good Clinical Practice Standards and HIPAA regulations to the conduct of clinical trials.

Demonstrates use of critical thinking skills and initiative to independently manage moderately complex project and multiple priorities.

Basic computer skills, particularly knowledge of Word, Excel and Adobe, and the ability to comfortably navigate various databases and online data repositories.

Current and working knowledge of clinical discipline(s) related to research scope.

Attends research procedures and/or verifies orders to ensure protocol requirements are adhered to; collaborates with investigators and other clinical staff, sees patients in clinic, performing follow-up exams and assessments, as needed, per study specific protocols.

Maintains and monitors various databases and/or patient case records for accuracy, quality of data, and assurance of compliance with protocol guidelines. Responds in a timely manner to requests for clarification (query) of the data submitted.

Administers research protocols according to policies and procedures, and federal and state guidelines regarding the involvement of human subjects in research protocols. Assesses patient responses and compliance, and documents results in electronic records or in other source documentation.

Identifies possible clinical trial candidates and/or clinical trial sites and confirms patient eligibility for clinical trial participation via assessment of clinical information and protocol requirements.

Collaborates with investigators and clinical staff to problem solve complex situations, including deviations from protocols, resulting in dose modification or protocol interpretations and best outcomes for patients, if applicable.

Identifies adverse events and assists in symptom management of patients on protocols through coordination/collaboration with physicians, clinical staff or other providers. Responsible for filing reports of adverse events, protocol deviations or unanticipated problems to study sponsors, IRB, and/or NCI, as applicable.

Conducts informed consent process to verify patient understanding of study and obtains appropriate documentation from patient or verifies receipt in compliance with federal, state and Institutional Review Board (IRB) guidelines.

Interacts with the research base and/or study sponsor to complete the clinical trial randomization/registration process and communicates the treatment assignment to appropriate institutional personnel.

Maintains accuracy and integrity of the clinical research database and research records.

Completes data submission, including collections and processing of biological/pathological materials per regulations, for clinical trial participants, and maintains contact with research participants for long term follow-up, as required by the protocol.

Provides educational information regarding the participation in clinical trials to patients and their families. 

Maintains and monitors investigational drugs and/or device inventories in compliance with National Cancer Institute (NCI) or Food and Drug Administration (FDA) drug accountability procedures for recording the receipt, use, transfer and dispensing of investigational drugs, if applicable.

Prepares for and/or facilitates audits conducted by the research base, study sponsor, National Cancer Institute (NCI) or Food and Drug Administration (FDA), including the preparation of patient information and source documentation.  Clarifies and defends documentation with auditors, as needed.  Participates in internal quality improvement activities and maintenance of Standard Operating Procedures.

Assists in analyzing new research protocols to determine local feasibility and identifying any barriers to successful study management. Monitors and reviews protocol amendments and implements changes, as needed.

Possess the information, skill, and understanding of the work to be performed.  Actively participates in continuing education opportunities and maintains certifications, licensure as appropriate.

Abides by all safety requirements including demonstrating proper hand hygiene and wearing of Personal Protective Equipment (PPE), if applicable. 

Complies with all standards, policies and procedures including dress code, attendance and punctuality.  Attends required in-services and meetings and completes all mandatory competencies by deadline. Commits to keeping all patient, student or colleague information confidential and maintains ongoing communication and collaboration with team members. 

The purpose of this job description is to provide a summary of the major responsibilities performed by colleagues in this position. Colleagues may be requested to perform tasks other than those specifically presented in this job description.  Variances in job duties performed may exist between facilities, and colleagues may perform other related duties as assigned to meet the needs of the organization.

PHYSICAL, MENTAL AND ENVIRONMENTAL REQUIREMENTS

Physical, Mental and Environmental Requirements Category:

Administrative

Standing

X

Walking

X

Sitting

X

Lifting

X

20 lbs.

Carrying

X

20 lbs.

Pushing

X

20 lbs.

Pulling

X

20 lbs.

Climbing

X

Balancing

X

Stooping

X

Kneeling

X

Crouching

X

Crawling

X

Reaching

X

Use of Hands/Dexterity

X

Talking

X

Hearing

X

Eye/Hand/Foot Coordination

X

Extreme Cold

X

Extreme Heat

X

Humid

X

Wet

X

Noise

X

Hazards

X

Temperature Change

X

Atmospheric Conditions

X

Vibration

X

Other